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Study 201283 is an exploratory, non-controlled, non-drug study in Amyotrophic Lateral Sclerosis (ALS) subjects. This study is being conducted as the first step for developing new meaningful measure(s) which might prove to be more effective than existing measures for monitoring clinical function and disease course in ALS. The objective of this study is to test novel measures of movement/physical activity, heart rate and speech and explore how they measure disease progression by evaluating their relationship to gold standard measures of function. This study will be conducted in two phases. A variable length Pilot Phase to test biotelemetry instruments and algorithms reliability and ease of use/acceptance. Approximately 5 subjects will have at least 1 clinic visit to perform a series of set reference tasks while wearing the accelerometer and electrode. Subjects will also continuously wear the accelerometer and electrode in their routine home-life setting for approximately 3 days after the clinic visit (i.e., home monitoring). Subjects in the Pilot Phase will continue in the study and participate in the Core Study Phase. A 48 week Core Study Phase will be conducted to evaluate how measures of movement/physical activity, speech and Heart Rate Variability (HRV) relate to ALS disease progression. During this phase, a maximum of 25 subjects will be enrolled. Subjects will attend 5 clinic visits to perform gold standard measures of function and perform a series of set reference tasks while wearing the accelerometer and electrode. In between clinic visits, every month subjects will attach the accelerometer and electrode and wear it for approximately 3 days in their home. A telephone contact with the subject will be made by the site at the end of each 3-day home monitoring period.
All third party trademark rights are the rights of their respective owners.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pilot and Core Study Phase | Experimental | During Pilot phase,subjects will attend clinic at least once to perform a series of set reference tasks while wearing the accelerometer and electrode. Subjects will also continuously wear the accelerometer and electrode in their routine home-life setting for approximately 3 days after the clinic visit (home monitoring). During 48 week Core Study, subjects will attend 5 clinic visits to perform gold standard measures of function (ALS Functional Rating Scale-Revised and Forced Vital Capacity) and perform a series of set reference tasks while wearing the accelerometer and electrode. Subjects will also continuously wear the accelerometer and electrode in their routine home-life setting for approximately 3 days after the clinic visits (home monitoring). In between clinic visits, subjects will attach the accelerometer and electrode and wear it for approximately 3 days in their home. A telephone contact with the subject will be made by the site at the end of each 3-day home monitoring period |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Faros Sensor (FS) and LifeInsight Hub | Device | Each subject will be issued one FS and a MAT LifeInsight Hub for use during the study. At each clinic visit in the Pilot and Core Study Phases, the Faros sensor will be placed on the subject just prior to the defined reference tasks and will be worn on the subject's sternum during completion of the tasks. The morning after the clinic visit, the subject will re-attach the sensor and wear it for approximately 3 days. In between visits during the Core Study Phase the subject will wear the FS every month for approximately 3 days to enable data collection on a monthly basis over the 48 week study period. Movement/physical activity data will be collected by the FS throughout the study. |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of Day Time Wear Time of the Device | Each participant was provided one accelerometer and electrode (Faros sensor and LifeInsight Hub) through which movement/physical activity data was collected throughout the study. Duration of day time wear time was calculated by adding the durations of the time spent [Active + lying + sedentary not lying] in the day time. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).NA indicates that data could not be calculated as participant number was <=1. | Up to Week 48 |
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| Measure | Description | Time Frame |
|---|---|---|
| Duration of Night Time Wear Time of the Device | Each participant was provided one accelerometer and electrode (Faros sensor and LifeInsight Hub) through which movement/physical activity data was collected throughout the study. Duration of night time wear time was the calculated as the total of the times spent [Active + day time lying + day time "sedentary not lying"] for the night time. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles). NA indicates that data could not be calculated as participant number was <=1. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | London | SE5 8AF | United Kingdom | |||
| GSK Investigational Site |
Of total 25 screened participants, 5 participants were included in pilot phase of which 2 completed and entered core study phase with other 23 participants.
This is an exploratory, non-controlled, non-drug study in participants with amyotrophic lateral sclerosis (ALS). The study enrolled participants using two sites based in the United Kingdom
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| ID | Title | Description |
|---|---|---|
| FG000 | Mega Faros Device + Fast Fix | In variable length Pilot Phase participants visited clinic to perform a series of set reference tasks while wearing the accelerometer (Faros device) and electrode (fast fix). Participants continuously wore the accelerometer and electrode in their routine home-life setting for approximately 3 days after the clinic visit (home monitoring). Participants in the Pilot Phase continued to participate in the Core Study Phase. A 48 week Core Study Phase was conducted to evaluate how measures of movement/physical activity, speech and Heart Rate Variability (HRV) relate to ALS disease progression. Participants attended clinic visits to perform gold standard measures of function and perform a series of set reference tasks while wearing the accelerometer and electrode. In between clinic visits, participants attached the accelerometer and electrode and wore it for approximately 3 days in their home. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Mega Faros Device + Fast Fix | In variable length Pilot Phase participants visited clinic to perform a series of set reference tasks while wearing the accelerometer (Faros device) and electrode (fast fix). Participants continuously wore the accelerometer and electrode in their routine home-life setting for approximately 3 days after the clinic visit (home monitoring). Participants in the Pilot Phase continued to participate in the Core Study Phase. A 48 week Core Study Phase was conducted to evaluate how measures of movement/physical activity, speech and Heart Rate Variability (HRV) relate to ALS disease progression. Participants attended clinic visits to perform gold standard measures of function and perform a series of set reference tasks while wearing the accelerometer and electrode. In between clinic visits, participants attached the accelerometer and electrode and wore it for approximately 3 days in their home. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Duration of Day Time Wear Time of the Device | Each participant was provided one accelerometer and electrode (Faros sensor and LifeInsight Hub) through which movement/physical activity data was collected throughout the study. Duration of day time wear time was calculated by adding the durations of the time spent [Active + lying + sedentary not lying] in the day time. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).NA indicates that data could not be calculated as participant number was <=1. | Full Analysis Set included all participants with at least one post Baseline measure for the Amyotrophic Lateral Sclerosis Functional Rating Scale-Revised (ALSFRS-R) and at least one physical activity/movement measure. | Posted | Mean | Standard Deviation | Minutes | Up to Week 48 |
|
On-treatment SAEs and non-serious AEs were collected from start of study treatment until Week 48.
On-treatment SAEs and non-serious AEs are reported for Safety Population
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Mega Faros Device + Fast Fix | During Pilot phase,subjects will attend clinic at least once to perform a series of set reference tasks while wearing the accelerometer and electrode. Subjects will also continuously wear the accelerometer and electrode in their routine home-life setting for approximately 3 days after the clinic visit (home monitoring). During 48 week Core Study, subjects will attend 5 clinic visits to perform gold standard measures of function (ALS Functional Rating Scale-Revised and Forced Vital Capacity) and perform a series of set reference tasks while wearing the accelerometer and electrode. Subjects will also continuously wear the accelerometer and electrode in their routine home-life setting for approximately 3 days after the clinic visits (home monitoring). In between clinic visits, subjects will attach the accelerometer and electrode and wear it for approximately 3 days in their home. A telephone contact with the subject will be made by the site at the end of each 3-day home monitoring period |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA 20.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | GlaxoSmithKline | 866-435-7343 | GSKClinicalSupportHD@gsk.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| SAP | No | Yes | No | Statistical Analysis Plan | Aug 3, 2017 | Feb 21, 2018 | SAP_000.pdf |
| Prot | Yes | No | No | Study Protocol | Sep 21, 2015 | Feb 22, 2018 | Prot_001.pdf |
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| ID | Term |
|---|---|
| D000690 | Amyotrophic Lateral Sclerosis |
| ID | Term |
|---|---|
| D013118 | Spinal Cord Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D016472 | Motor Neuron Disease |
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| Fast Fix electrode patch | Device | The Fast Fix electrode patch will be worn with the FS on the subject's sternum according to the same schedule as the FS. The Fast Fix electrode patch will be replaced by the subject on a daily basis during the 3 day monitoring period. Subjects will be provided instructions on how to operate and wear the Fast Fix electrode patch. |
|
| Quantitative Measure of Speech (Core Phase Only) | Procedure | Subjects will follow simple prompts on a computer screen instructing them to say a series of vowels, words, and paragraphs which will be recorded using a high definition digital microphone and stored securely on a laptop. The speech waveform data will be sent via secure method to GSK/MAT for processing. |
|
| Up to Week 48 |
| Average Time Spent Active | Number of minutes spent active per day and night over the 24-hour recording periods; averaged for each time point. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles) | Up to Week 48 |
| Average Time Spent 'Sedentary Not Lying' | Number of minutes spent 'sedentary not lying' per day and night for 24-hour recording period; averaged for each time point. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles). | Up to Week 48 |
| Average Time Spent Lying | Number of minutes spent lying per day and night over the 24-hour recording periods; averaged for each time point. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles). | Up to Week 48 |
| Average Time Spent Sedentary. | Number of minutes spent sedentary [time spent lying + time spent sedentary not lying] per day and night over the 24-hour recording periods; averaged for each time point. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles). | Up to Week 48 |
| Time Spent With Sensor Off | Sensor off time includes the time that the sensor was either switched off or the participant was not wearing it (or both). This outcome measure was planned but not performed. | Up to Week 48 |
| Total Activity Count | Total activity count for the day time and night time for the 24-hour recording periods; averaged for each time point. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles). | Up to Week 48 |
| Maximum Activity Count in a 24 Hour Period | Maximum activity count for the day time and night time for the 24-hour recording periods; averaged for each time point. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles) | Up to Week 48 |
| Mean Maximum Activity Count in a 24 Hour Period | Mean maximum activity count of day time and night time for the 24-hour recording periods; averaged for each time point. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles) | Up to Week 48 |
| Number of Continuous Active Periods | Active periods were catagorized as >1minute to <=2minutes, >2 minutes to <=5minutes, >5 minutes to <=15 minutes, >15 minutes to <=30 minutes, >30 minutes. Total number of 'active periods were calculated as 1minute<x<2minutes + 'number of active periods 2minutes<x<5minutes + 'number of active periods 5minutes<x<15minutes + 'number of active periods 15minutes<x<30minutes + 'number of active periods >30minutes. | Up to Week 48 |
| Percent of Time Lying Down at Night | Percent time spent lying per day and night over the 24-hour recording periods; averaged for each timepoint | Up to Week 48 |
| Number of Night Time Movement Episodes Per Hour | Average number of night movement episodes per hour for each protocol time point. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles). | Up to Week 48 |
| Percent Time Night-time Rest Efficiency | Average night-time rest efficiency for each protocol time point. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles) | Up to Week 48 |
| Rest Fragmentation Index | Rest Fragmentation Index was computed as movement time (%) divided by number of movement episodes for each protocol time point. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles). | Up to Week 48 |
| Average Duration of Night Time Movement Episodes | Average duration of movement episodes for each time point. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles). | Up to Week 48 |
| Relationship Between Average Number Night Time Movements/Hour Versus Total ALSFRS-R | Estimates for between and within subject correlation coefficients were produced following multiple linear regression analyses on the actigraphy endpoints, comparing them with the ALSFRS-R total score and the gross motor domain and fine motor domain scores. Data for between subject correlation coefficient has been presented | Up to Week 48 |
| Relationship Between Average Duration Movement Episodes at Night Versus Total ALSFRS-R | Estimates for between and within subject correlation coefficients were produced following multiple linear regression analyses on the actigraphy endpoints, comparing them with the ALSFRS-R total score and the gross motor domain and fine motor domain scores. Data for between subject correlation coefficient has been presented | Up to Week 48 |
| Relationship Between Average Percent Time Night Time Rest Efficiency Versus Total ALSFRS-R | Estimates for between and within subject correlation coefficients were produced following multiple linear regression analyses on the actigraphy endpoints, comparing them with the ALSFRS-R total score and the gross motor domain and fine motor domain scores. Data for between subject correlation coefficient has been presented | Up to Week 48 |
| Relationship Between Average Night Time Rest Fragmentation Index Versus Total ALSFRS-R | Estimates for between and within subject correlation coefficients were produced following multiple linear regression analyses on the actigraphy endpoints, comparing them with the ALSFRS-R total score and the gross motor domain and fine motor domain scores. Data for between subject correlation coefficient has been presented | Up to Week 48 |
| Mean Heart Rate Variability (HRV) While Lying (Low Frequency[LF]/High Frequency[HF]) | Mean Heart Rate Variability (HRV) averaged over 5 windows of lying down at each protocol time point. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles). | Up to Week 48 |
| Variance of HRV While Lying (LF/HF) | Variance of Heart Rate Variability (HRV) averaged over 5 windows of lying down at each protocol time point (LF/HF analysis). Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles). | Up to Week 48 |
| Mean HRV While Sedentary Not Lying (LF/HF) | Mean Heart Rate Variability (HRV) averaged over 5 windows of sedentary not lying at each protocol time point (LF/HF analysis). Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles). | Up to Week 48 |
| Variance of HRV While Sedentary Not Lying (LF/HF) | Variance of Heart Rate Variability (HRV) averaged over 5 windows of sedentary not lying at each protocol time point. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles). | Up to Week 48 |
| Mean HRV While Active (LF/HF) | Mean Heart Rate Variability (HRV) averaged over 5 windows of subjects being active at each protocol time point (LF/HF analysis). Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles). NA indicates that data is not available. Standard deviation could not be calculated when number of participants was <=1 | Up to Week 48 |
| Variance of HRV While Active (LF/HF) | Variance of Heart Rate Variability (HRV) averaged over 5 windows of subjects being active at each protocol time point (LF/HF analysis). Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles). NA indicates that data could not be calculated as participant number was <=1 | Up to Week 48 |
| Effect of Being Upright on HRV- Mean HRV (LF/HF Analysis) | The effect of being upright on mean HRV was calculated as [mean HRV while sedentary not lying minus mean HRV while lying] (LF/HF analysis). Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles). | Up to Week 48 |
| Effect of Being Upright on HRV Variance (LF/HF Analysis) | The effect of being upright on HRV variance was calculated as [HRV variance while sedentary not lying minus HRV variance while lying] (LF/HF analysis). Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles). | Up to Week 48 |
| Effect of Activity on Mean HRV (LF/HF) | The effect of activity on mean HRV was calculated as [mean HRV while sedentary not lying minus mean HRV while lying] (LF/HF analysis). Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles). NA indicates that data could not be calculated as participant number was <=1. | Up to Week 48 |
| Effect of Activity on HRV Variance (LF/HF Analysis) | The effect of activity on HRV variance was calculated as [HRV variance while sedentary not lying minus HRV variance while lying] (LF/HF analysis). Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles). NA indicates that data could not be calculated as participant number was <=1. | Up to Week 48 |
| Mean HRV Over 24 Hours - Mean Root Mean Square of the Successive Differences (RMSSD) | Mean HRV over 24 hours (RMSSD analysis), averaged for each protocol time point. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles). | Up to Week 48 |
| HRV Variance Over 24 Hours - Mean Root Mean Square of the Successive Differences (RMSSD) Analysis | HRV variance over 24 hours (RMSSD analysis), averaged for each protocol time point. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles). | Up to Week 48 |
| Relationship Between Absolute Values of HRV Endpoints (LF/HF) and Absolute Value of Total ALSFRS-R | Estimates for between and within subject correlation coefficients were produced following multiple linear regression analyses on the actigraphy endpoints, comparing them with the ALSFRS-R total score and the gross motor domain and fine motor domain scores. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles). NA indicates that sample size was insufficient to calculate correlation coefficient | Up to Week 48 |
| Measurement of Speech Quality | Speech quality was assessed by Central Tendency of Fundamental Frequency (CTF) F0, jitter, and shimmer for 'short ah' and 'long ah' tests. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles). | Up to Week 48 |
| Duration of Maximum Gap Between Words | Duration of maximum gap between words during running speech to planned to analyze quality of speech however; was not performed. | Up to Week 48 |
| Speaking Rate | Speaking rate was analyzed during running speech. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles). | Up to Week 48 |
| Average Phoneme Rate | Phoneme rate was analyzed for the single word "doily". Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles). | Up to Week 48 |
| Maximum Phonation Time | Maximum phonation time for the single word "doily" test was analyzed for quality of speech testing. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles). | Seconds |
| Percentage Pause Time | Percentage pause time for running speech was analyzed. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles). | Up to Week 48 |
| Relationship Between Absolute Values of Speech Endpoints and Absolute Value of ALSFRS-R | Mixed Model was used to calculate Repeated Measures Correlation Coefficients between the two variables when model is converged. The correlation coefficient among the repeated measurements is same for different variables. Multiple Linear Regression was used to calculate Within and Between Participant Correlation Coefficients when Mixed Model is not converged. Data for Repeated Measures Correlation Coefficient has been presented in the table below | Up to Week 48 |
| Relationship Between Absolute Values of Speech Endpoints and Absolute Values of FVC | Mixed Model was used to calculate Repeated Measures Correlation Coefficients between the two variables when model is converged. The correlation coefficient among the repeated measurements is same for different variables. Multiple Linear Regression was used to calculate Within and Between Participant Correlation Coefficients when Mixed Model is not converged. Data for Between Subject Correlation Coefficient has been presented in the table below | Up to Week 48 |
| Number of Participants Reporting Sensor Comfort | Participant's feedback on whether the sensor was comfortable to wear was categorized as "yes" and "no". Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles). | Up to Week 48 |
| Number of Participants Reporting Impact on Sleep | Participant feedback on how much the sensor impacted their sleep was categorized as "not at all", "moderately" and "minimally". Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles). | Up to Week 48 |
| Number of Participants With Ease of Setting up and Attaching the Sensor | The participants were required to give feedback on how easy was it to set up and/ or attach the sensor and it was categorized as "easy", "neutral" and "difficult". Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles). | Up to Week 48 |
| Number of Participants With Corresponding Activity Level Required to Complete Their Job | The activity level required by the participant to complete their job was recorded, and was categorized as Not working, Physical activity required, and Sedentary. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles). | Up to Week 48 |
| Number of Participants With Corresponding Average Activity Level During Time of Wearing the Sensor | Average activity level during the time of wearing the sensor was reported by the participants, and was categorized as very low level activity, low level activity, moderate level activity and high level activity. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles). | Up to Week 48 |
| Number of Participants Whose Sensor Fell Off | The participants reported whether the sensor fell off. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles). | Up to Week 48 |
| Number of Participants With Adverse Events Secondary to the Devices Used or Due to Study Procedures | Only those AEs and SAEs which, in the opinion of the investigator, were related to a protocol-mandated procedure or one of the devices used in the study were reported. An AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect, any other situation according to medical or scientific judgment that may not be immediately life-threatening or result in death or hospitalization but may jeopardize the participant or may require medical or surgical intervention or event associated with liver injury and impaired liver function were categorized as SAE. | Up to Week 48 |
| Type of Adverse Events Secondary to the Devices Used or Due to Study Procedures | Only those AEs and SAEs which, in the opinion of the investigator, were related to a protocol-mandated procedure or one of the devices used in the study were reported. An AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect, any other situation according to medical or scientific judgment that may not be immediately life-threatening or result in death or hospitalization but may jeopardize the participant or may require medical or surgical intervention or event associated with liver injury and impaired liver function were categorized as SAE. Number of AEs, SAEs and Adverse events leading to discontinuation (AELDs)from the study is presented | Up to Week 48 |
| Oxford |
| OX3 9DU |
| United Kingdom |
| Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Number | Participants |
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In variable length Pilot Phase participants visited clinic to perform a series of set reference tasks while wearing the accelerometer (Faros device) and electrode (fast fix). Participants continuously wore the accelerometer and electrode in their routine home-life setting for approximately 3 days after the clinic visit (home monitoring). Participants in the Pilot Phase continued to participate in the Core Study Phase. A 48 week Core Study Phase was conducted to evaluate how measures of movement/physical activity, speech and Heart Rate Variability (HRV) relate to ALS disease progression. Participants attended clinic visits to perform gold standard measures of function and perform a series of set reference tasks while wearing the accelerometer and electrode. In between clinic visits, participants attached the accelerometer and electrode and wore it for approximately 3 days in their home.
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| Other Pre-specified | Duration of Night Time Wear Time of the Device | Each participant was provided one accelerometer and electrode (Faros sensor and LifeInsight Hub) through which movement/physical activity data was collected throughout the study. Duration of night time wear time was the calculated as the total of the times spent [Active + day time lying + day time "sedentary not lying"] for the night time. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles). NA indicates that data could not be calculated as participant number was <=1. | Full Analysis Set | Posted | Mean | Standard Deviation | Minutes | Up to Week 48 |
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| Other Pre-specified | Average Time Spent Active | Number of minutes spent active per day and night over the 24-hour recording periods; averaged for each time point. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles) | Full Analysis Set | Posted | Mean | Standard Deviation | Minutes | Up to Week 48 |
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| Other Pre-specified | Average Time Spent 'Sedentary Not Lying' | Number of minutes spent 'sedentary not lying' per day and night for 24-hour recording period; averaged for each time point. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles). | Full Analysis Set | Posted | Mean | Standard Deviation | Minutes | Up to Week 48 |
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| Other Pre-specified | Average Time Spent Lying | Number of minutes spent lying per day and night over the 24-hour recording periods; averaged for each time point. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles). | Full Analysis Set | Posted | Mean | Standard Deviation | Minutes | Up to Week 48 |
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| Other Pre-specified | Average Time Spent Sedentary. | Number of minutes spent sedentary [time spent lying + time spent sedentary not lying] per day and night over the 24-hour recording periods; averaged for each time point. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles). | Full Analysis Set | Posted | Mean | Standard Deviation | Minutes | Up to Week 48 |
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| Other Pre-specified | Time Spent With Sensor Off | Sensor off time includes the time that the sensor was either switched off or the participant was not wearing it (or both). This outcome measure was planned but not performed. | Full Analysis Set | Posted | Up to Week 48 |
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| Other Pre-specified | Total Activity Count | Total activity count for the day time and night time for the 24-hour recording periods; averaged for each time point. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles). | Full Analysis Set | Posted | Mean | Standard Deviation | Count of activity | Up to Week 48 |
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| Other Pre-specified | Maximum Activity Count in a 24 Hour Period | Maximum activity count for the day time and night time for the 24-hour recording periods; averaged for each time point. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles) | Full Analysis Set | Posted | Mean | Standard Deviation | Count of activity | Up to Week 48 |
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| Other Pre-specified | Mean Maximum Activity Count in a 24 Hour Period | Mean maximum activity count of day time and night time for the 24-hour recording periods; averaged for each time point. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles) | Full Analysis Set | Posted | Mean | Standard Deviation | Count of activity | Up to Week 48 |
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| Other Pre-specified | Number of Continuous Active Periods | Active periods were catagorized as >1minute to <=2minutes, >2 minutes to <=5minutes, >5 minutes to <=15 minutes, >15 minutes to <=30 minutes, >30 minutes. Total number of 'active periods were calculated as 1minute<x<2minutes + 'number of active periods 2minutes<x<5minutes + 'number of active periods 5minutes<x<15minutes + 'number of active periods 15minutes<x<30minutes + 'number of active periods >30minutes. | Full Analysis Set | Posted | Mean | Standard Deviation | Number/Hour | Up to Week 48 |
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| Other Pre-specified | Percent of Time Lying Down at Night | Percent time spent lying per day and night over the 24-hour recording periods; averaged for each timepoint | Full Analysis Set | Posted | Mean | Standard Deviation | Percentage of time | Up to Week 48 |
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| Other Pre-specified | Number of Night Time Movement Episodes Per Hour | Average number of night movement episodes per hour for each protocol time point. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles). | Full Analysis Set | Posted | Mean | Standard Deviation | Number of movements/hour | Up to Week 48 |
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| Other Pre-specified | Percent Time Night-time Rest Efficiency | Average night-time rest efficiency for each protocol time point. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles) | Full Analysis Set | Posted | Mean | Standard Deviation | Percentage of time | Up to Week 48 |
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|
| Other Pre-specified | Rest Fragmentation Index | Rest Fragmentation Index was computed as movement time (%) divided by number of movement episodes for each protocol time point. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles). | Full Analysis Set | Posted | Mean | Standard Deviation | Ratio | Up to Week 48 |
|
|
|
| Other Pre-specified | Average Duration of Night Time Movement Episodes | Average duration of movement episodes for each time point. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles). | Full Analysis Set | Posted | Mean | Standard Deviation | Seconds | Up to Week 48 |
|
|
|
| Other Pre-specified | Relationship Between Average Number Night Time Movements/Hour Versus Total ALSFRS-R | Estimates for between and within subject correlation coefficients were produced following multiple linear regression analyses on the actigraphy endpoints, comparing them with the ALSFRS-R total score and the gross motor domain and fine motor domain scores. Data for between subject correlation coefficient has been presented | Full Analysis Set | Posted | Number | Ratio | Up to Week 48 |
|
|
|
| Other Pre-specified | Relationship Between Average Duration Movement Episodes at Night Versus Total ALSFRS-R | Estimates for between and within subject correlation coefficients were produced following multiple linear regression analyses on the actigraphy endpoints, comparing them with the ALSFRS-R total score and the gross motor domain and fine motor domain scores. Data for between subject correlation coefficient has been presented | Full Analysis Set | Posted | Number | Ratio | Up to Week 48 |
|
|
|
| Other Pre-specified | Relationship Between Average Percent Time Night Time Rest Efficiency Versus Total ALSFRS-R | Estimates for between and within subject correlation coefficients were produced following multiple linear regression analyses on the actigraphy endpoints, comparing them with the ALSFRS-R total score and the gross motor domain and fine motor domain scores. Data for between subject correlation coefficient has been presented | Full Analysis Set | Posted | Number | Ratio | Up to Week 48 |
|
|
|
| Other Pre-specified | Relationship Between Average Night Time Rest Fragmentation Index Versus Total ALSFRS-R | Estimates for between and within subject correlation coefficients were produced following multiple linear regression analyses on the actigraphy endpoints, comparing them with the ALSFRS-R total score and the gross motor domain and fine motor domain scores. Data for between subject correlation coefficient has been presented | Full Analysis Set | Posted | Number | Ratio | Up to Week 48 |
|
|
|
| Other Pre-specified | Mean Heart Rate Variability (HRV) While Lying (Low Frequency[LF]/High Frequency[HF]) | Mean Heart Rate Variability (HRV) averaged over 5 windows of lying down at each protocol time point. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles). | Full Analysis Set | Posted | Mean | Standard Deviation | Ratio | Up to Week 48 |
|
|
|
| Other Pre-specified | Variance of HRV While Lying (LF/HF) | Variance of Heart Rate Variability (HRV) averaged over 5 windows of lying down at each protocol time point (LF/HF analysis). Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles). | Full Analysis Set | Posted | Mean | Standard Deviation | Ratio | Up to Week 48 |
|
|
|
| Other Pre-specified | Mean HRV While Sedentary Not Lying (LF/HF) | Mean Heart Rate Variability (HRV) averaged over 5 windows of sedentary not lying at each protocol time point (LF/HF analysis). Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles). | Full Analysis Set | Posted | Mean | Standard Deviation | Ratio | Up to Week 48 |
|
|
|
| Other Pre-specified | Variance of HRV While Sedentary Not Lying (LF/HF) | Variance of Heart Rate Variability (HRV) averaged over 5 windows of sedentary not lying at each protocol time point. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles). | Full Analysis Set | Posted | Mean | Standard Deviation | Ratio | Up to Week 48 |
|
|
|
| Other Pre-specified | Mean HRV While Active (LF/HF) | Mean Heart Rate Variability (HRV) averaged over 5 windows of subjects being active at each protocol time point (LF/HF analysis). Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles). NA indicates that data is not available. Standard deviation could not be calculated when number of participants was <=1 | Full Analysis Set | Posted | Mean | Standard Deviation | Ratio | Up to Week 48 |
|
|
|
| Other Pre-specified | Variance of HRV While Active (LF/HF) | Variance of Heart Rate Variability (HRV) averaged over 5 windows of subjects being active at each protocol time point (LF/HF analysis). Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles). NA indicates that data could not be calculated as participant number was <=1 | Full Analysis Set | Posted | Mean | Standard Deviation | Ratio | Up to Week 48 |
|
|
|
| Other Pre-specified | Effect of Being Upright on HRV- Mean HRV (LF/HF Analysis) | The effect of being upright on mean HRV was calculated as [mean HRV while sedentary not lying minus mean HRV while lying] (LF/HF analysis). Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles). | Full Analysis Set | Posted | Mean | Standard Deviation | Ratio | Up to Week 48 |
|
|
|
| Other Pre-specified | Effect of Being Upright on HRV Variance (LF/HF Analysis) | The effect of being upright on HRV variance was calculated as [HRV variance while sedentary not lying minus HRV variance while lying] (LF/HF analysis). Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles). | Full Analysis Set | Posted | Mean | Standard Deviation | Ratio | Up to Week 48 |
|
|
|
| Other Pre-specified | Effect of Activity on Mean HRV (LF/HF) | The effect of activity on mean HRV was calculated as [mean HRV while sedentary not lying minus mean HRV while lying] (LF/HF analysis). Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles). NA indicates that data could not be calculated as participant number was <=1. | Full Analysis Set | Posted | Mean | Standard Deviation | Ratio | Up to Week 48 |
|
|
|
| Other Pre-specified | Effect of Activity on HRV Variance (LF/HF Analysis) | The effect of activity on HRV variance was calculated as [HRV variance while sedentary not lying minus HRV variance while lying] (LF/HF analysis). Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles). NA indicates that data could not be calculated as participant number was <=1. | Full Analysis Set | Posted | Mean | Standard Deviation | Ratio | Up to Week 48 |
|
|
|
| Other Pre-specified | Mean HRV Over 24 Hours - Mean Root Mean Square of the Successive Differences (RMSSD) | Mean HRV over 24 hours (RMSSD analysis), averaged for each protocol time point. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles). | Full Analysis Set | Posted | Mean | Standard Deviation | Milliseconds^2 | Up to Week 48 |
|
|
|
| Other Pre-specified | HRV Variance Over 24 Hours - Mean Root Mean Square of the Successive Differences (RMSSD) Analysis | HRV variance over 24 hours (RMSSD analysis), averaged for each protocol time point. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles). | Full Analysis Set | Posted | Mean | Standard Deviation | Milliseconds^2 | Up to Week 48 |
|
|
|
| Other Pre-specified | Relationship Between Absolute Values of HRV Endpoints (LF/HF) and Absolute Value of Total ALSFRS-R | Estimates for between and within subject correlation coefficients were produced following multiple linear regression analyses on the actigraphy endpoints, comparing them with the ALSFRS-R total score and the gross motor domain and fine motor domain scores. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles). NA indicates that sample size was insufficient to calculate correlation coefficient | Full Analysis Set | Posted | Number | Ratio | Up to Week 48 |
|
|
|
| Other Pre-specified | Measurement of Speech Quality | Speech quality was assessed by Central Tendency of Fundamental Frequency (CTF) F0, jitter, and shimmer for 'short ah' and 'long ah' tests. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles). | Full Analysis Set | Posted | Mean | Standard Deviation | Hertz | Up to Week 48 |
|
|
|
| Other Pre-specified | Duration of Maximum Gap Between Words | Duration of maximum gap between words during running speech to planned to analyze quality of speech however; was not performed. | Full Analysis Set | Posted | Up to Week 48 |
|
|
| Other Pre-specified | Speaking Rate | Speaking rate was analyzed during running speech. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles). | Full Analysis Set | Posted | Mean | Standard Deviation | Words per minute | Up to Week 48 |
|
|
|
| Other Pre-specified | Average Phoneme Rate | Phoneme rate was analyzed for the single word "doily". Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles). | Full Analysis Set | Posted | Mean | Standard Deviation | Hertz per second | Up to Week 48 |
|
|
|
| Other Pre-specified | Maximum Phonation Time | Maximum phonation time for the single word "doily" test was analyzed for quality of speech testing. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles). | Full Analysis Set | Posted | Mean | Standard Deviation | Seconds | Seconds |
|
|
|
| Other Pre-specified | Percentage Pause Time | Percentage pause time for running speech was analyzed. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles). | Full Analysis Set | Posted | Mean | Standard Deviation | Percentage of time | Up to Week 48 |
|
|
|
| Other Pre-specified | Relationship Between Absolute Values of Speech Endpoints and Absolute Value of ALSFRS-R | Mixed Model was used to calculate Repeated Measures Correlation Coefficients between the two variables when model is converged. The correlation coefficient among the repeated measurements is same for different variables. Multiple Linear Regression was used to calculate Within and Between Participant Correlation Coefficients when Mixed Model is not converged. Data for Repeated Measures Correlation Coefficient has been presented in the table below | Full Analysis Set | Posted | Number | Ratio | Up to Week 48 |
|
|
|
| Other Pre-specified | Relationship Between Absolute Values of Speech Endpoints and Absolute Values of FVC | Mixed Model was used to calculate Repeated Measures Correlation Coefficients between the two variables when model is converged. The correlation coefficient among the repeated measurements is same for different variables. Multiple Linear Regression was used to calculate Within and Between Participant Correlation Coefficients when Mixed Model is not converged. Data for Between Subject Correlation Coefficient has been presented in the table below | Full Analysis Set | Posted | Number | Ratio | Up to Week 48 |
|
|
|
| Other Pre-specified | Number of Participants Reporting Sensor Comfort | Participant's feedback on whether the sensor was comfortable to wear was categorized as "yes" and "no". Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles). | Full Analysis Set | Posted | Number | Participants | Up to Week 48 |
|
|
|
| Other Pre-specified | Number of Participants Reporting Impact on Sleep | Participant feedback on how much the sensor impacted their sleep was categorized as "not at all", "moderately" and "minimally". Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles). | Full Analysis Set | Posted | Number | Participants | Up to Week 48 |
|
|
|
| Other Pre-specified | Number of Participants With Ease of Setting up and Attaching the Sensor | The participants were required to give feedback on how easy was it to set up and/ or attach the sensor and it was categorized as "easy", "neutral" and "difficult". Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles). | Full Analysis Set | Posted | Number | Participants | Up to Week 48 |
|
|
|
| Other Pre-specified | Number of Participants With Corresponding Activity Level Required to Complete Their Job | The activity level required by the participant to complete their job was recorded, and was categorized as Not working, Physical activity required, and Sedentary. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles). | Full Analysis Set | Posted | Number | Participants | Up to Week 48 |
|
|
|
| Other Pre-specified | Number of Participants With Corresponding Average Activity Level During Time of Wearing the Sensor | Average activity level during the time of wearing the sensor was reported by the participants, and was categorized as very low level activity, low level activity, moderate level activity and high level activity. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles). | Full Analysis Set | Posted | Number | Participants | Up to Week 48 |
|
|
|
| Other Pre-specified | Number of Participants Whose Sensor Fell Off | The participants reported whether the sensor fell off. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles). | Full Analysis Set | Posted | Number | Participants | Up to Week 48 |
|
|
|
| Other Pre-specified | Number of Participants With Adverse Events Secondary to the Devices Used or Due to Study Procedures | Only those AEs and SAEs which, in the opinion of the investigator, were related to a protocol-mandated procedure or one of the devices used in the study were reported. An AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect, any other situation according to medical or scientific judgment that may not be immediately life-threatening or result in death or hospitalization but may jeopardize the participant or may require medical or surgical intervention or event associated with liver injury and impaired liver function were categorized as SAE. | Safety Population comprised of all participants who carried out at least one protocol specified procedure | Posted | Number | Participants | Up to Week 48 |
|
|
|
| Other Pre-specified | Type of Adverse Events Secondary to the Devices Used or Due to Study Procedures | Only those AEs and SAEs which, in the opinion of the investigator, were related to a protocol-mandated procedure or one of the devices used in the study were reported. An AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect, any other situation according to medical or scientific judgment that may not be immediately life-threatening or result in death or hospitalization but may jeopardize the participant or may require medical or surgical intervention or event associated with liver injury and impaired liver function were categorized as SAE. Number of AEs, SAEs and Adverse events leading to discontinuation (AELDs)from the study is presented | Safety Population | Posted | Number | Events | Up to Week 48 |
|
|
|
| 0 |
| 25 |
| 0 |
| 25 |
| 6 |
| 25 |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 20.0 | Systematic Assessment |
|
| Rash pruritic | Skin and subcutaneous tissue disorders | MedDRA 20.0 | Systematic Assessment |
|
| Skin irritation | Skin and subcutaneous tissue disorders | MedDRA 20.0 | Systematic Assessment |
|
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
| D019636 | Neurodegenerative Diseases |
| D057177 | TDP-43 Proteinopathies |
| D009468 | Neuromuscular Diseases |
| D057165 | Proteostasis Deficiencies |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
|
| Week 0, Day 3, n=23 |
|
|
| Week 0, Day 4, n=12 |
|
|
| Week 0, Day 5, n=2 |
|
|
| Week4, Day 1, n=22 |
|
|
| Week4, Day 2, n=22 |
|
|
| Week4, Day 3, n=21 |
|
|
| Week4, Day 4, n=9 |
|
|
| Week4, Day 5, n=5 |
|
|
| Week4, Day 6, n=1 |
|
|
| Week4, Day 7, n=1 |
|
|
| Week4, Day 8, n=1 |
|
|
| Week8, Day 1, n=19 |
|
|
| Week8, Day 2, n=17 |
|
|
| Week8, Day 3, n=17 |
|
|
| Week8, Day 4, n=8 |
|
|
| Week12,Day 1, n=16 |
|
|
| Week12,Day 2, n=16 |
|
|
| Week12,Day 3, n=15 |
|
|
| Week12,Day 4, n=7 |
|
|
| Week12,Day 5, n=1 |
|
|
| Week16,Day 1, n=13 |
|
|
| Week16,Day 2, n=13 |
|
|
| Week16,Day 3, n=12 |
|
|
| Week16,Day 4, n=6 |
|
|
| Week20,Day 1, n=14 |
|
|
| Week20,Day 2, n=13 |
|
|
| Week20,Day 3, n=12 |
|
|
| Week20,Day 4, n=4 |
|
|
| Week24,Day 1, n=14 |
|
|
| Week24,Day 2, n=12 |
|
|
| Week24,Day 3, n=11 |
|
|
| Week24,Day 4, n=8 |
|
|
| Week24,Day 5, n=2 |
|
|
| Week28,Day 1, n=10 |
|
|
| Week28,Day 2, n=10 |
|
|
| Week28,Day 3, n=9 |
|
|
| Week28,Day 4, n=6 |
|
|
| Week32,Day 1, n=12 |
|
|
| Week32,Day 2, n=10 |
|
|
| Week32,Day 3, n=9 |
|
|
| Week32,Day 4, n=1 |
|
|
| Week36,Day 1, n=12 |
|
|
| Week36,Day 2, n=9 |
|
|
| Week36,Day 3, n=6 |
|
|
| Week36,Day 4, n=4 |
|
|
| Week36,Day 5, n=2 |
|
|
| Week36,Day 6, n=1 |
|
|
| Week40,Day 1, n=12 |
|
|
| Week40,Day 2, n=12 |
|
|
| Week40,Day 3, n=11 |
|
|
| Week40,Day 4, n=7 |
|
|
| Week40,Day 5, n=1 |
|
|
| Week40,Day 6, n=1 |
|
|
| Week44,Day 1, n=12 |
|
|
| Week44,Day 2, n=11 |
|
|
| Week44,Day 3, n=10 |
|
|
| Week44,Day 4, n=4 |
|
|
| Week44,Day 5, n=1 |
|
|
| Week48,Day 1, n=13 |
|
|
| Week48,Day 2, n=13 |
|
|
| Week48,Day 3, n=10 |
|
|
| Week48,Day 4, n=5 |
|
|
|
| Day time, Week 8, n=19 |
|
|
| Day time, Week 12, n=16 |
|
|
| Day time, Week 16, n=13 |
|
|
| Day time, Week 20, n=14 |
|
|
| Day time, Week 24, n=14 |
|
|
| Day time, Week 28, n=10 |
|
|
| Day time, Week 32, n=12 |
|
|
| Day time, Week 36, n=12 |
|
|
| Day time, Week 40, n=12 |
|
|
| Day time, Week 44, n=12 |
|
|
| Day time, Week 48, n=13 |
|
|
| Night time, Week 0, n=24 |
|
|
| Night time, Week 4, n=22 |
|
|
| Night time, Week 8, n=19 |
|
|
| Night time, Week 12, n=16 |
|
|
| Night time, Week 16, n=13 |
|
|
| Night time, Week 20, n=14 |
|
|
| Night time, Week 24, n=14 |
|
|
| Night time, Week 28, n=10 |
|
|
| Night time, Week 32, n=12 |
|
|
| Night time, Week 36, n=12 |
|
|
| Night time, Week 40, n=12 |
|
|
| Night time, Week 44, n=12 |
|
|
| Night time, Week 48, n=13 |
|
|
|
| Day time, Week 8, n=19 |
|
|
| Day time, Week 12, n=16 |
|
|
| Day time, Week 16, n=13 |
|
|
| Day time, Week 20, n=14 |
|
|
| Day time, Week 24, n=14 |
|
|
| Day time, Week 28, n=10 |
|
|
| Day time, Week 32, n=12 |
|
|
| Day time, Week 36, n=12 |
|
|
| Day time, Week 40, n=12 |
|
|
| Day time, Week 44, n=12 |
|
|
| Day time, Week 48, n=13 |
|
|
| Night time, Week 0, n=24 |
|
|
| Night time, Week 4, n=22 |
|
|
| Night time, Week 8, n=19 |
|
|
| Night time, Week 12, n=16 |
|
|
| Night time, Week 16, n=13 |
|
|
| Night time, Week 20, n=14 |
|
|
| Night time, Week 24, n=14 |
|
|
| Night time, Week 28, n=10 |
|
|
| Night time, Week 32, n=12 |
|
|
| Night time, Week 36, n=12 |
|
|
| Night time, Week 40, n=12 |
|
|
| Night time, Week 44, n=12 |
|
|
| Night time, Week 48, n=13 |
|
|
|
| Day time, Week 8, n=19 |
|
|
| Day time, Week 12, n=16 |
|
|
| Day time, Week 16, n=13 |
|
|
| Day time, Week 20, n=14 |
|
|
| Day time, Week 24, n=14 |
|
|
| Day time, Week 28, n=10 |
|
|
| Day time, Week 32, n=12 |
|
|
| Day time, Week 36, n=12 |
|
|
| Day time, Week 40, n=12 |
|
|
| Day time, Week 44, n=12 |
|
|
| Day time, Week 48, n=13 |
|
|
| Night time, Week 0, n=24 |
|
|
| Night time, Week 4, n=22 |
|
|
| Night time, Week 8, n=19 |
|
|
| Night time, Week 12, n=16 |
|
|
| Night time, Week 16, n=13 |
|
|
| Night time, Week 20, n=14 |
|
|
| Night time, Week 24, n=14 |
|
|
| Night time, Week 28, n=10 |
|
|
| Night time, Week 32, n=12 |
|
|
| Night time, Week 36, n=12 |
|
|
| Night time, Week 40, n=12 |
|
|
| Night time, Week 44, n=12 |
|
|
| Night time, Week 48, n=13 |
|
|
|
| Day time, Week 8, n=19 |
|
|
| Day time, Week 12, n=16 |
|
|
| Day time, Week 16, n=13 |
|
|
| Day time, Week 20, n=14 |
|
|
| Day time, Week 24, n=14 |
|
|
| Day time, Week 28, n=10 |
|
|
| Day time, Week 32, n=12 |
|
|
| Day time, Week 36, n=12 |
|
|
| Day time, Week 40, n=12 |
|
|
| Day time, Week 44, n=12 |
|
|
| Day time, Week 48, n=13 |
|
|
| Night time, Week 0, n=24 |
|
|
| Night time, Week 4, n=22 |
|
|
| Night time, Week 8, n=19 |
|
|
| Night time, Week 12, n=16 |
|
|
| Night time, Week 16, n=13 |
|
|
| Night time, Week 20, n=14 |
|
|
| Night time, Week 24, n=14 |
|
|
| Night time, Week 28, n=10 |
|
|
| Night time, Week 32, n=12 |
|
|
| Night time, Week 36, n=12 |
|
|
| Night time, Week 40, n=12 |
|
|
| Night time, Week 44, n=12 |
|
|
| Night time, Week 48, n=13 |
|
|
|
| Day time, Week 8, n=17 |
|
|
| Day time, Week 12, n=16 |
|
|
| Day time, Week 16, n=13 |
|
|
| Day time, Week 20, n=14 |
|
|
| Day time, Week 24, n=13 |
|
|
| Day time, Week 28, n=10 |
|
|
| Day time, Week 32, n=12 |
|
|
| Day time, Week 36, n=12 |
|
|
| Day time, Week 40, n=12 |
|
|
| Day time, Week 44, n=12 |
|
|
| Day time, Week 48, n=13 |
|
|
| Night time, Week 0, n=24 |
|
|
| Night time, Week 4, n=22 |
|
|
| Night time, Week 8, n=13 |
|
|
| Night time, Week 12, n=16 |
|
|
| Night time, Week 16, n=13 |
|
|
| Night time, Week 20, n=14 |
|
|
| Night time, Week 24, n=14 |
|
|
| Night time, Week 28, n=10 |
|
|
| Night time, Week 32, n=12 |
|
|
| Night time, Week 36, n=10 |
|
|
| Night time, Week 40, n=12 |
|
|
| Night time, Week 44, n=11 |
|
|
| Night time, Week 48, n=13 |
|
|
|
| Day time, Week 8, n=17 |
|
|
| Day time, Week 12, n=16 |
|
|
| Day time, Week 16, n=13 |
|
|
| Day time, Week 20, n=14 |
|
|
| Day time, Week 24, n=13 |
|
|
| Day time, Week 28, n=10 |
|
|
| Day time, Week 32, n=12 |
|
|
| Day time, Week 36, n=12 |
|
|
| Day time, Week 40, n=12 |
|
|
| Day time, Week 44, n=12 |
|
|
| Day time, Week 48, n=13 |
|
|
| Night time, Week 0, n=24 |
|
|
| Night time, Week 4, n=22 |
|
|
| Night time, Week 8, n=19 |
|
|
| Night time, Week 12, n=16 |
|
|
| Night time, Week 16, n=13 |
|
|
| Night time, Week 20, n=13 |
|
|
| Night time, Week 24, n=14 |
|
|
| Night time, Week 28, n=10 |
|
|
| Night time, Week 32, n=12 |
|
|
| Night time, Week 36, n=10 |
|
|
| Night time, Week 40, n=12 |
|
|
| Night time, Week 44, n=11 |
|
|
| Night time, Week 48, n=13 |
|
|
|
| Day time, Week 8, n=17 |
|
|
| Day time, Week 12, n=16 |
|
|
| Day time, Week 16, n=13 |
|
|
| Day time, Week 20, n=14 |
|
|
| Day time, Week 24, n=13 |
|
|
| Day time, Week 28, n=10 |
|
|
| Day time, Week 32, n=12 |
|
|
| Day time, Week 36, n=12 |
|
|
| Day time, Week 40, n=12 |
|
|
| Day time, Week 44, n=12 |
|
|
| Day time, Week 48, n=13 |
|
|
| Night time, Week 0, n=24 |
|
|
| Night time, Week 4, n=22 |
|
|
| Night time, Week 8, n=19 |
|
|
| Night time, Week 12, n=16 |
|
|
| Night time, Week 16, n=13 |
|
|
| Night time, Week 20, n=13 |
|
|
| Night time, Week 24, n=14 |
|
|
| Night time, Week 28, n=10 |
|
|
| Night time, Week 32, n=12 |
|
|
| Night time, Week 36, n=10 |
|
|
| Night time, Week 40, n=12 |
|
|
| Night time, Week 44, n=11 |
|
|
| Night time, Week 48, n=13 |
|
|
|
| >1 to <=2minutes;Day time, Week 8, n=18 |
|
|
| >1 to <=2minutes;Day time, Week 12, n=16 |
|
|
| >1 to <=2minutes;Day time, Week 16, n=13 |
|
|
| >1 to <=2minutes;Day time, Week 20, n=14 |
|
|
| >1 to <=2minutes;Day time, Week 24, n=14 |
|
|
| >1 to <=2minutes;Day time, Week 28, n=10 |
|
|
| >1 to <=2minutes;Day time, Week 32, n=12 |
|
|
| >1 to <=2minutes;Day time, Week 36, n=12 |
|
|
| >1 to <=2minutes;Day time, Week 40, n=12 |
|
|
| >1 to <=2minutes;Day time, Week 44, n=12 |
|
|
| >1 to <=2minutes;Day time, Week 48, n=13 |
|
|
| >2 to <=5minutes; Day time, Week 0, n=24 |
|
|
| >2 to <=5minutes;Day time, Week 4, n=22 |
|
|
| >2 to <=5minutes;Day time, Week 8, n=18 |
|
|
| >2 to <=5minutes;Day time, Week 12, n=16 |
|
|
| >2 to <=5minutes;Day time, Week 16, n=13 |
|
|
| >2 to <=5minutes;Day time, Week 20, n=14 |
|
|
| >2 to <=5minutes;Day time, Week 24, n=14 |
|
|
| >2 to <=5minutes;Day time, Week 28, n=10 |
|
|
| >2 to <=5minutes;Day time, Week 32, n=12 |
|
|
| >2 to <=5minutes;Day time, Week 36, n=12 |
|
|
| >2 to <=5minutes;Day time, Week 40, n=12 |
|
|
| >2 to <=5minutes;Day time, Week 44, n=12 |
|
|
| >2 to <=5minutes;Day time, Week 48, n=13 |
|
|
| >5 to <=15 minutes; Day time, Week 0, n=24 |
|
|
| >5 to <=15 minutes;Day time, Week 4, n=22 |
|
|
| >5 to <=15 minutes;Day time, Week 8, n=18 |
|
|
| >5 to <=15 minutes;Day time, Week 12, n=16 |
|
|
| >5 to <=15 minutes;Day time, Week 16, n=13 |
|
|
| >5 to <=15 minutes;Day time, Week 20, n=14 |
|
|
| >5 to <=15 minutes;Day time, Week 24, n=14 |
|
|
| >5 to <=15 minutes;Day time, Week 28, n=10 |
|
|
| >5 to <=15 minutes;Day time, Week 32, n=12 |
|
|
| >5 to <=15 minutes;Day time, Week 36, n=12 |
|
|
| >5 to <=15 minutes;Day time, Week 40, n=12 |
|
|
| >5 to <=15 minutes;Day time, Week 44, n=12 |
|
|
| >5 to <=15 minutes;Day time, Week 48, n=13 |
|
|
| >15 to <=30 minutes; Day time, Week 0, n=24 |
|
|
| >15 to <=30 minutes;Day time, Week 4, n=22 |
|
|
| >15 to <=30 minutes;Day time, Week 8, n=18 |
|
|
| >15 to <=30 minutes;Day time, Week 12, n=16 |
|
|
| >15 to <=30 minutes;Day time, Week 16, n=13 |
|
|
| >15 to <=30 minutes;Day time, Week 20, n=14 |
|
|
| >15 to <=30 minutes;Day time, Week 24, n=14 |
|
|
| >15 to <=30 minutes;Day time, Week 28, n=10 |
|
|
| >15 to <=30 minutes;Day time, Week 32, n=12 |
|
|
| >15 to <=30 minutes;Day time, Week 36, n=12 |
|
|
| >15 to <=30 minutes;Day time, Week 40, n=12 |
|
|
| >15 to <=30 minutes;Day time, Week 44, n=12 |
|
|
| >15 to <=30 minutes;Day time, Week 48, n=13 |
|
|
| >30 minutes; Day time, Week 0, n=24 |
|
|
| >30 minutes;Day time, Week 4, n=22 |
|
|
| >30 minutes;Day time, Week 8, n=18 |
|
|
| >30 minutes;Day time, Week 12, n=16 |
|
|
| >30 minutes;Day time, Week 16, n=13 |
|
|
| >30 minutes;Day time, Week 20, n=14 |
|
|
| >30 minutes;Day time, Week 24, n=14 |
|
|
| >30 minutes;Day time, Week 28, n=10 |
|
|
| >30 minutes;Day time, Week 32, n=12 |
|
|
| >30 minutes;Day time, Week 36, n=12 |
|
|
| >30 minutes;Day time, Week 40, n=12 |
|
|
| >30 minutes;Day time, Week 44, n=12 |
|
|
| >30 minutes;Day time, Week 48, n=13 |
|
|
| >1 to <=2minutes; Night time, Week 0, n=24 |
|
|
| >1 to <=2minutes;Night time, Week 4, n=22 |
|
|
| >1 to <=2minutes;Night time, Week 8, n=19 |
|
|
| >1 to <=2minutes;Night time, Week 12, n=16 |
|
|
| >1 to <=2minutes;Night time, Week 16, n=13 |
|
|
| >1 to <=2minutes;Night time, Week 20, n=13 |
|
|
| >1 to <=2minutes;Night time, Week 24, n=14 |
|
|
| >1 to <=2minutes;Night time, Week 28, n=10 |
|
|
| >1 to <=2minutes;Night time, Week 32, n=12 |
|
|
| >1 to <=2minutes;Night time, Week 36, n=10 |
|
|
| >1 to <=2minutes;Night time, Week 40, n=12 |
|
|
| >1 to <=2minutes;Night time, Week 44, n=11 |
|
|
| >1 to <=2minutes;Night time, Week 48, n=13 |
|
|
| >2 to <=5minutes; Night time, Week 0, n=24 |
|
|
| >2 to <=5minutes;Night time, Week 4, n=22 |
|
|
| >2 to <=5minutes;Night time, Week 8, n=19 |
|
|
| >2 to <=5minutes;Night time, Week 12, n=16 |
|
|
| >2 to <=5minutes;Night time, Week 16, n=13 |
|
|
| >2 to <=5minutes;Night time, Week 20, n=13 |
|
|
| >2 to <=5minutes;Night time, Week 24, n=14 |
|
|
| >2 to <=5minutes;Night time, Week 28, n=10 |
|
|
| >2 to <=5minutes;Night time, Week 32, n=12 |
|
|
| >2 to <=5minutes;Night time, Week 36, n=10 |
|
|
| >2 to <=5minutes;Night time, Week 40, n=12 |
|
|
| >2 to <=5minutes;Night time, Week 44, n=11 |
|
|
| >2 to <=5minutes;Night time, Week 48, n=13 |
|
|
| >5 to <=15 minutes; Night time, Week 0, n=24 |
|
|
| >5 to <=15 minutes;Night time, Week 4, n=22 |
|
|
| >5 to <=15 minutes;Night time, Week 8, n=19 |
|
|
| >5 to <=15 minutes;Night time, Week 12, n=16 |
|
|
| >5 to <=15 minutes;Night time, Week 16, n=13 |
|
|
| >5 to <=15 minutes;Night time, Week 20, n=13 |
|
|
| >5 to <=15 minutes;Night time, Week 24, n=14 |
|
|
| >5 to <=15 minutes;Night time, Week 28, n=10 |
|
|
| >5 to <=15 minutes;Night time, Week 32, n=12 |
|
|
| >5 to <=15 minutes;Night time, Week 36, n=10 |
|
|
| >5 to <=15 minutes;Night time, Week 40, n=12 |
|
|
| >5 to <=15 minutes;Night time, Week 44, n=11 |
|
|
| >5 to <=15 minutes;Night time, Week 48, n=13 |
|
|
| >15 to <=30 minutes; Night time, Week 0, n=24 |
|
|
| >15 to <=30 minutes;Night time, Week 4, n=22 |
|
|
| >15 to <=30 minutes;Night time, Week 8, n=19 |
|
|
| >15 to <=30 minutes;Night time, Week 12, n=16 |
|
|
| >15 to <=30 minutes;Night time, Week 16, n=13 |
|
|
| >15 to <=30 minutes;Night time, Week 20, n=13 |
|
|
| >15 to <=30 minutes;Night time, Week 24, n=14 |
|
|
| >15 to <=30 minutes;Night time, Week 28, n=10 |
|
|
| >15 to <=30 minutes;Night time, Week 32, n=12 |
|
|
| >15 to <=30 minutes;Night time, Week 36, n=10 |
|
|
| >15 to <=30 minutes;Night time, Week 40, n=12 |
|
|
| >15 to <=30 minutes;Night time, Week 44, n=11 |
|
|
| >15 to <=30 minutes;Night time, Week 48, n=13 |
|
|
| >30 minutes; Night time, Week 0, n=24 |
|
|
| >30 minutes;Night time, Week 4, n=22 |
|
|
| >30 minutes;Night time, Week 8, n=19 |
|
|
| >30 minutes;Night time, Week 12, n=16 |
|
|
| >30 minutes;Night time, Week 16, n=13 |
|
|
| >30 minutes;Night time, Week 20, n=13 |
|
|
| >30 minutes;Night time, Week 24, n=14 |
|
|
| >30 minutes;Night time, Week 28, n=10 |
|
|
| >30 minutes;Night time, Week 32, n=12 |
|
|
| >30 minutes;Night time, Week 36, n=10 |
|
|
| >30 minutes;Night time, Week 40, n=12 |
|
|
| >30 minutes;Night time, Week 44, n=11 |
|
|
| >30 minutes;Night time, Week 48, n=13 |
|
|
|
| Day time, Week 8, n=18 |
|
|
| Day time, Week 12, n=16 |
|
|
| Day time, Week 16, n=13 |
|
|
| Day time, Week 20, n=14 |
|
|
| Day time, Week 24, n=14 |
|
|
| Day time, Week 28, n=10 |
|
|
| Day time, Week 32, n=12 |
|
|
| Day time, Week 36, n=12 |
|
|
| Day time, Week 40, n=12 |
|
|
| Day time, Week 44, n=12 |
|
|
| Day time, Week 48, n=13 |
|
|
| Night time, Week 0, n=24 |
|
|
| Night time, Week 4, n=22 |
|
|
| Night time, Week 8, n=19 |
|
|
| Night time, Week 12, n=16 |
|
|
| Night time, Week 16, n=13 |
|
|
| Night time, Week 20, n=13 |
|
|
| Night time, Week 24, n=14 |
|
|
| Night time, Week 28, n=10 |
|
|
| Night time, Week 32, n=12 |
|
|
| Night time, Week 36, n=10 |
|
|
| Night time, Week 40, n=12 |
|
|
| Night time, Week 44, n=11 |
|
|
| Night time, Week 48, n=13 |
|
|
|
| Week 8, n=19 |
|
|
| Week 12, n=16 |
|
|
| Week 16, n=13 |
|
|
| Week 20, n=13 |
|
|
| Week 24, n=14 |
|
|
| Week 28, n=10 |
|
|
| Week 32, n=12 |
|
|
| Week 36, n=10 |
|
|
| Week 40, n=12 |
|
|
| Week 44, n=11 |
|
|
| Week 48, n=13 |
|
|
|
| Week 8, n=19 |
|
|
| Week 12, n=16 |
|
|
| Week 16, n=13 |
|
|
| Week 20, n=13 |
|
|
| Week 24, n=14 |
|
|
| Week 28, n=10 |
|
|
| Week 32, n=12 |
|
|
| Week 36, n=10 |
|
|
| Week 40, n=12 |
|
|
| Week 44, n=11 |
|
|
| Week 48, n=13 |
|
|
|
| Week 8, n=19 |
|
|
| Week 12, n=16 |
|
|
| Week 16, n=13 |
|
|
| Week 20, n=13 |
|
|
| Week 24, n=14 |
|
|
| Week 28, n=10 |
|
|
| Week 32, n=12 |
|
|
| Week 36, n=10 |
|
|
| Week 40, n=12 |
|
|
| Week 44, n=11 |
|
|
| Week 48, n=13 |
|
|
|
| Week 8, n=19 |
|
|
| Week 12, n=16 |
|
|
| Week 16, n=13 |
|
|
| Week 20, n=13 |
|
|
| Week 24, n=14 |
|
|
| Week 28, n=10 |
|
|
| Week 32, n=11 |
|
|
| Week 36, n=9 |
|
|
| Week 40, n=11 |
|
|
| Week 44, n=11 |
|
|
| Week 48, n=12 |
|
|
|
| Week 8, n=15 |
|
|
| Week 12, n=15 |
|
|
| Week 16, n=12 |
|
|
| Week 20, n=12 |
|
|
| Week 24, n=12 |
|
|
| Week 28, n=10 |
|
|
| Week 32, n=10 |
|
|
| Week 36, n=9 |
|
|
| Week 40, n=11 |
|
|
| Week 44, n=11 |
|
|
| Week 48, n=11 |
|
|
|
| Week 8, n=15 |
|
|
| Week 12, n=15 |
|
|
| Week 16, n=12 |
|
|
| Week 20, n=12 |
|
|
| Week 24, n=12 |
|
|
| Week 28, n=10 |
|
|
| Week 32, n=10 |
|
|
| Week 36, n=9 |
|
|
| Week 40, n=11 |
|
|
| Week 44, n=11 |
|
|
| Week 48, n=11 |
|
|
|
| Week 8, n=13 |
|
|
| Week 12, n=14 |
|
|
| Week 16, n=11 |
|
|
| Week 20, n=10 |
|
|
| Week 24, n=10 |
|
|
| Week 28, n=9 |
|
|
| Week 32, n=9 |
|
|
| Week 36, n=11 |
|
|
| Week 40, n=9 |
|
|
| Week 44, n=9 |
|
|
| Week 48, n=7 |
|
|
|
| Week 8, n=13 |
|
|
| Week 12, n=14 |
|
|
| Week 16, n=11 |
|
|
| Week 20, n=10 |
|
|
| Week 24, n=10 |
|
|
| Week 28, n=9 |
|
|
| Week 32, n=9 |
|
|
| Week 36, n=11 |
|
|
| Week 40, n=9 |
|
|
| Week 44, n=9 |
|
|
| Week 48, n=7 |
|
|
|
|
|
| Week 8, n=13 |
|
|
| Week 12, n=14 |
|
|
| Week 16, n=11 |
|
|
| Week 20, n=10 |
|
|
| Week 24, n=10 |
|
|
| Week 28, n=9 |
|
|
| Week 32, n=9 |
|
|
| Week 36, n=9 |
|
|
| Week 40, n=9 |
|
|
| Week 44, n=9 |
|
|
| Week 48, n=6 |
|
|
|
| Week 8, n=13 |
|
|
| Week 12, n=14 |
|
|
| Week 16, n=11 |
|
|
| Week 20, n=10 |
|
|
| Week 24, n=10 |
|
|
| Week 28, n=9 |
|
|
| Week 32, n=9 |
|
|
| Week 36, n=9 |
|
|
| Week 40, n=9 |
|
|
| Week 44, n=9 |
|
|
| Week 48, n=6 |
|
|
|
|
|
| Week 8, n=15 |
|
|
| Week 12, n=16 |
|
|
| Week 16, n=12 |
|
|
| Week 20, n=12 |
|
|
| Week 24, n=12 |
|
|
| Week 28, n=10 |
|
|
| Week 32, n=10 |
|
|
| Week 36, n=11 |
|
|
| Week 40, n=11 |
|
|
| Week 44, n=11 |
|
|
| Week 48, n=12 |
|
|
|
| Week 8, n=15 |
|
|
| Week 12, n=16 |
|
|
| Week 16, n=12 |
|
|
| Week 20, n=12 |
|
|
| Week 24, n=12 |
|
|
| Week 28, n=10 |
|
|
| Week 32, n=10 |
|
|
| Week 36, n=11 |
|
|
| Week 40, n=11 |
|
|
| Week 44, n=11 |
|
|
| Week 48, n=12 |
|
|
|
| Mean LF/HF sedentary (not lying) v/s ALSFRS-R;n=24 |
|
|
| Var. LF/HF sedentary (not lying) v/s ALSFR-R;n=24 |
|
|
| Mean HRV effect of activity v/s ALSFRS-R;n=3 |
|
|
| Mean LF/HF (avg-daytime activity) v/s ALSFRS-R;n=3 |
|
|
| Var of HRV effect of activity v/s ALSFRS-R;n=3 |
|
|
| Var of HRV effect being upright v/s ALSFRS-R;n=24 |
|
|
| Var of LF/HF (lying down) v/s ALSFRS-R;n=25 |
|
|
| Var of LF/HF v/s ALSFRS-R;n=3 |
|
|
|
| CTF F0;Week24;n=17 (Short ah) |
|
|
| CTF F0;Week36;n=15 (Short ah) |
|
|
| CTF F0;Week48;n=18 (Short ah) |
|
|
| CTF F0;EWD;n=3 (Short ah) |
|
|
| Jitter;Week0;n=25 (Short ah) |
|
|
| Jitter;Week12;n=18 (Short ah) |
|
|
| Jitter;Week24;n=17 (Short ah) |
|
|
| Jitter;Week36;n=15 (Short ah) |
|
|
| Jitter;Week48;n=18 (Short ah) |
|
|
| Jitter;EWD;n=2 (Short ah) |
|
|
| Shimmer;Week0;n=25 (Short ah) |
|
|
| Shimmer;Week12;n=18 (Short ah) |
|
|
| Shimmer;Week24;n=17 (Short ah) |
|
|
| Shimmer;Week36;n=15 (Short ah) |
|
|
| Shimmer;Week48;n=18 (Short ah) |
|
|
| Shimmer;EWD;n=2 (Short ah) |
|
|
| CTF F0;Week0;n=25 (Long ah) |
|
|
| CTF F0;Week12;n=18 (Long ah) |
|
|
| CTF F0;Week24;n=17 (Long ah) |
|
|
| CTF F0;Week36;n=15 (Long ah) |
|
|
| CTF F0;Week48;n=18 (Long ah) |
|
|
| CTF F0;EWD;n=3 (Long ah) |
|
|
| Jitter;Week0;n=25 (Long ah) |
|
|
| Jitter;Week12;n=18 (Long ah) |
|
|
| Jitter;Week24;n=17 (Long ah) |
|
|
| Jitter;Week36;n=15 (Long ah) |
|
|
| Jitter;Week48;n=18 (Long ah) |
|
|
| Jitter;EWD;n=2 (Long ah) |
|
|
| Shimmer;Week0;n=25 (Long ah) |
|
|
| Shimmer;Week12;n=18 (Long ah) |
|
|
| Shimmer;Week24;n=17 (Long ah) |
|
|
| Shimmer;Week36;n=15 (Long ah) |
|
|
| Shimmer;Week48;n=18 (Long ah) |
|
|
| Shimmer;EWD;n=2 (Long ah) |
|
|
|
| Week24; n=17 |
|
|
| Week36; n=15 |
|
|
| Week48; n=18 |
|
|
| EWD; n=2 |
|
|
|
| Week24; n=17 |
|
|
| Week36; n=15 |
|
|
| Week48; n=18 |
|
|
| EWD; n=2 |
|
|
|
| Week24; n=17 |
|
|
| Week36; n=15 |
|
|
| Week48; n=18 |
|
|
| EWD; n=2 |
|
|
|
| Week24; n=17 |
|
|
| Week36; n=15 |
|
|
| Week48; n=18 |
|
|
| EWD; n=2 |
|
|
| Title | Measurements |
|---|---|
|
| Shimmer(%) (Long ah) v/s ALSFRS-R |
|
| Maximum Phonation Time v/s ALSFRS-R |
|
| Title | Measurements |
|---|---|
|
| CTF F0 (Long ah) v/s FVC |
|
| Jitter (%) (Long ah) v/s FVC |
|
| Shimmer(%) (Long ah) v/s FVC |
|
| Average Phoneme Rate v/s FVC |
|
| Maximum Phonation Time v/s FVC |
|
| Percent Pause Time v/s FVC |
|
| Speaking Rate v/s FVC |
|
|
| Sensor comfortable to wear;Pilot repeat; n=5;Yes |
|
|
| Sensor comfortable to wear;Pilot repeat; n=5;No |
|
|
| Sensor comfortable to wear;Week12; n=15;Yes |
|
|
| Sensor comfortable to wear;Week12; n=15;No |
|
|
| Sensor comfortable to wear;Week24; n=14; Yes |
|
|
| Sensor comfortable to wear;Week24; n=14;No |
|
|
| Sensor comfortable to wear;Week36; n=14; Yes |
|
|
| Sensor comfortable to wear;Week36; n=14; No |
|
|
| Sensor comfortable to wear;Week48; n=18; Yes |
|
|
| Sensor comfortable to wear;Week48; n=18;No |
|
|
| Sensor comfortable to wear;EWD; n=2;Yes |
|
|
| Sensor comfortable to wear;EWD; n=2;No |
|
|
|
| Minimally; Pilot; n=5 |
|
|
| Not at all;Pilot repeat; n=5 |
|
|
| Moderately;Pilot repeat; n=5 |
|
|
| Minimally; Pilot repeat; n=5 |
|
|
| Not at all;Week12; n=15 |
|
|
| Moderately;Week12; n=15 |
|
|
| Minimally; Week12; n=15 |
|
|
| Not at all;Week24; n=14 |
|
|
| Moderately;Week24; n=14 |
|
|
| Minimally; Week24; n=14 |
|
|
| Not at all;Week36; n=14 |
|
|
| Moderately;Week36; n=14 |
|
|
| Minimally; Week36; n=14 |
|
|
| Not at all;Week48; n=18 |
|
|
| Moderately;Week48; n=18 |
|
|
| Minimally; Week48; n=18 |
|
|
| Not at all;EWD; n=2 |
|
|
| Moderately;EWD; n=2 |
|
|
| Minimally; EWD; n=2 |
|
|
|
| Difficult;Pilot; n=5 |
|
|
| Easy;Pilot repeat; n=5 |
|
|
| Neutral;Pilot repeat; n=5 |
|
|
| Difficult;Pilot repeat; n=5 |
|
|
| Easy;Week0; n=25 |
|
|
| Neutral;Week0; n=25 |
|
|
| Difficult;Week0; n=25 |
|
|
| Easy;Week4; n=23 |
|
|
| Neutral;Week4; n=23 |
|
|
| Difficult;Week4; n=23 |
|
|
| Easy;Week8; n=21 |
|
|
| Neutral;Week8; n=21 |
|
|
| Difficult;Week8; n=21 |
|
|
| Easy;Week12; n=20 |
|
|
| Neutral;Week12; n=20 |
|
|
| Difficult;Week12; n=20 |
|
|
| Easy;Week16; n=18 |
|
|
| Neutral;Week16; n=18 |
|
|
| Difficult;Week16; n=18 |
|
|
| Easy;Week20; n=20 |
|
|
| Neutral;Week20; n=20 |
|
|
| Difficult;Week20; n=20 |
|
|
| Easy;Week24; n=18 |
|
|
| Neutral;Week24; n=18 |
|
|
| Difficult;Week24; n=18 |
|
|
| Easy;Week28; n=16 |
|
|
| Neutral;Week28; n=16 |
|
|
| Difficult;Week28; n=16 |
|
|
| Easy;Week32; n=20 |
|
|
| Neutral;Week32; n=20 |
|
|
| Difficult;Week32; n=20 |
|
|
| Easy;Week36; n=18 |
|
|
| Neutral;Week36; n=18 |
|
|
| Difficult;Week36; n=18 |
|
|
| Easy;Week40; n=15 |
|
|
| Neutral;Week40; n=15 |
|
|
| Difficult;Week40; n=15 |
|
|
| Easy;Week44; n=16 |
|
|
| Neutral;Week44; n=16 |
|
|
| Difficult;Week44; n=16 |
|
|
| Easy;Week48; n=15 |
|
|
| Neutral;Week48; n=15 |
|
|
| Difficult;Week48; n=15 |
|
|
|
| Pilot; Sedentary;n=5 |
|
|
| Pilot repeat; Not working;n=5 |
|
|
| Pilot Repeat; Physical activity required;n=5 |
|
|
| Pilot Repeat; Sedentary;n=5 |
|
|
| Week0; Not working;n=25 |
|
|
| Week0; Physical activity required;n=25 |
|
|
| Week0; Sedentary;n=25 |
|
|
| Week4; Not working;n=23 |
|
|
| Week4; Physical activity required;n=23 |
|
|
| Week4; Sedentary;n=23 |
|
|
| Week8; Not working;n=21 |
|
|
| Week8; Physical activity required;n=21 |
|
|
| Week8; Sedentary;n=21 |
|
|
| Week12; Not working;n=20 |
|
|
| Week12; Physical activity required;n=20 |
|
|
| Week12; Sedentary;n=20 |
|
|
| Week16; Not working;n=18 |
|
|
| Week16; Physical activity required;n=18 |
|
|
| Week16; Sedentary;n=18 |
|
|
| Week20; Not working;n=20 |
|
|
| Week20; Physical activity required;n=20 |
|
|
| Week20; Sedentary;n=20 |
|
|
| Week24; Not working;n=18 |
|
|
| Week24; Physical activity required;n=18 |
|
|
| Week24; Sedentary;n=18 |
|
|
| Week28; Not working;n=16 |
|
|
| Week28; Physical activity required;n=16 |
|
|
| Week28; Sedentary;n=16 |
|
|
| Week32; Not working;n=20 |
|
|
| Week32; Physical activity required;n=20 |
|
|
| Week32; Sedentary;n=20 |
|
|
| Week36; Not working;n=18 |
|
|
| Week36; Physical activity required;n=18 |
|
|
| Week36; Sedentary;n=18 |
|
|
| Week40; Not working;n=15 |
|
|
| Week40; Physical activity required;n=15 |
|
|
| Week40; Sedentary;n=15 |
|
|
| Week44; Not working;n=16 |
|
|
| Week44; Physical activity required;n=16 |
|
|
| Week44; Sedentary;n=16 |
|
|
| Week48; Not working;n=15 |
|
|
| Week48; Physical activity required;n=15 |
|
|
| Week48; Sedentary;n=15 |
|
|
|
| Pilot;Moderate level activity;n=5 |
|
|
| Pilot;High level activity;n=5 |
|
|
| Pilot repeat;Very low level activity;n=5 |
|
|
| Pilot repeat; Low level activity; n=5 |
|
|
| Pilot repeat;Moderate level activity;n=5 |
|
|
| Pilot repeat;High level activity;n=5 |
|
|
| Week0;Very low level activity;n=25 |
|
|
| Week0;Low level activity;n=25 |
|
|
| Week0;Moderate level activity;n=25 |
|
|
| Week0;High level activity;n=25 |
|
|
| Week4;Very low level activity;n=23 |
|
|
| Week4;Low level activity;n=23 |
|
|
| Week4;Moderate level activity;n=23 |
|
|
| Week4;High level activity;n=23 |
|
|
| Week8;Very low level activity;n=21 |
|
|
| Week8;Low level activity;n=21 |
|
|
| Week8;Moderate level activity;n=21 |
|
|
| Week8;High level activity;n=21 |
|
|
| Week12;Very low level activity;n=20 |
|
|
| Week12;Low level activity;n=20 |
|
|
| Week12;Moderate level activity;n=20 |
|
|
| Week12;High level activity;n=20 |
|
|
| Week16;Very low level activity;n=18 |
|
|
| Week16;Low level activity;n=18 |
|
|
| Week16;Moderate level activity;n=18 |
|
|
| Week16;High level activity;n=18 |
|
|
| Week20;Very low level activity;n=20 |
|
|
| Week20;Low level activity;n=20 |
|
|
| Week20;Moderate level activity;n=20 |
|
|
| Week20;High level activity;n=20 |
|
|
| Week24;Very low level activity;n=18 |
|
|
| Week24;Low level activity;n=18 |
|
|
| Week24;Moderate level activity;n=18 |
|
|
| Week24;High level activity;n=18 |
|
|
| Week28;Very low level activity;n=16 |
|
|
| Week28;Low level activity;n=16 |
|
|
| Week28;Moderate level activity;n=16 |
|
|
| Week28;High level activity;n=16 |
|
|
| Week32;Very low level activity;n=20 |
|
|
| Week32;Low level activity;n=20 |
|
|
| Week32;Moderate level activity;n=20 |
|
|
| Week32;High level activity;n=20 |
|
|
| Week36;Very low level activity;n=18 |
|
|
| Week36;Low level activity;n=18 |
|
|
| Week36;Moderate level activity;n=18 |
|
|
| Week36;High level activity;n=18 |
|
|
| Week40;Very low level activity;n=15 |
|
|
| Week40;Low level activity;n=15 |
|
|
| Week40;Moderate level activity;n=15 |
|
|
| Week40;High level activity;n=15 |
|
|
| Week44;Very low level activity;n=16 |
|
|
| Week44;Low level activity;n=16 |
|
|
| Week44;Moderate level activity;n=16 |
|
|
| Week44;High level activity;n=16 |
|
|
| Week48;Very low level activity;n=15 |
|
|
| Week48;Low level activity;n=15 |
|
|
| Week48;Moderate level activity;n=15 |
|
|
| Week48;High level activity;n=15 |
|
|
|
| Pilot Repeat;Yes;n=5 |
|
|
| Pilot Repeat;No;n=5 |
|
|
| Week 0; Yes; n=25 |
|
|
| Week 0; No; n=25 |
|
|
| Week 4; Yes;n=23 |
|
|
| Week 4;No; n=23 |
|
|
| Week 8; Yes; n=21 |
|
|
| Week 8; No; n=21 |
|
|
| Week 12; Yes;n=20 |
|
|
| Week 12;No;n=20 |
|
|
| Week 16;Yes; n=18 |
|
|
| Week 16;No; n=18 |
|
|
| Week 20; Yes; n=20 |
|
|
| Week 20; No; n=20 |
|
|
| Week 24;Yes; n=18 |
|
|
| Week 24;No; n=18 |
|
|
| Week 28;Yes; n=16 |
|
|
| Week 28;No; n=16 |
|
|
| Week 32;Yes; n=20 |
|
|
| Week 32;No; n=20 |
|
|
| Week 36;Yes; n=18 |
|
|
| Week 36;No; n=18 |
|
|
| Week 40;Yes; n=15 |
|
|
| Week 40;No; n=15 |
|
|
| Week 44;Yes; n=16 |
|
|
| Week 44;No; n=16 |
|
|
| Week 48;Yes; n=15 |
|
|
| Week 48;No; n=15 |
|
|