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| Name | Class |
|---|---|
| Fisher and Paykel Healthcare | INDUSTRY |
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This study will investigate Obstructive Sleep Apnea (OSA) and an automatically Adjusting Positive Airway Pressure (APAP) device with new technology called SensAwake™. This requires experimental confirmation in a randomised controlled trial with crossover design, comparing compliance on standard APAP with compliance using APAP modified by the addition of the SensAwake™ modification on consecutive nights in participants with moderate-to-severe OSA.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| APAP begins without SensAwake | No Intervention | Patients will receive CPAP treatment without SensAwake™ activation for two weeks, then crossed-over to CPAP treatment with SensAwake™ activation for additional two weeks. | |
| APAP begins with SensAwake | Experimental | Patients will receive CPAP treatment with SensAwake™ activation for two weeks, then crossed-over to CPAP treatment without SensAwake™ activation for additional two weeks. SensAwake™ modification: SensAwake™ is a new design based on the research of Doctor Ayappa 5 years ago. The SensAwake™ modification to the Fisher and Paykel automatically titrating positive airway pressure (APAP) device aims to sense whether the patient is awake via respiratory patterns that differentiate between sleep and wake. Upon sensing that the patient is awake the device is able to reduce positive airway pressure PAP aiming to improve patient comfort which should result in more consolidated sleep. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SensAwake™ modification | Device | SensAwake™ is a new design based on the research of Doctor Ayappa 5 years ago. The SensAwake™ modification to the Fisher and Paykel automatically titrating positive airway pressure (APAP) device aims to sense whether the patient is awake via respiratory patterns that differentiate between sleep and wake. Upon sensing that the patient is awake the device is able to reduce positive airway pressure PAP aiming to improve patient comfort which should result in more consolidated sleep. |
| Measure | Description | Time Frame |
|---|---|---|
| Compliance of Auto-CPAP Therapy | Objective data recorded in the auto-CPAP machine, Percentage of nights of using auto-CPAP for at least 4 hours during therapy. | 2 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Average SA Detections | Average detects of arousal per hours. (Objective data recorded in the auto-CPAP machine) | 2 weeks |
| Average Pressures of Auto-CPAP Machine | Average Pressures of Auto-CPAP Machine (Objective data recorded in the auto-CPAP machine) |
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Inclusion Criteria:
1. Participants will be recruited from OSA patients who will remove CPAP himself without any notable reasons.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Li-Pang Chuang, MD | ChangGungMemorialHospital | Principal Investigator |
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March 2015 to Mar 2016, at medical clinic.
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| ID | Title | Description |
|---|---|---|
| FG000 | CPAP w/SensAwake First, Then CPAP w/o SensAwake | Patients will receive CPAP treatment with SensAwake™ activation for two weeks, then crossed-over to CPAP treatment without SensAwake™ activation for additional two weeks. No washout period. |
| FG001 | CPAP w/o SensAwake First, Then CPAP w/SensAwake | Patients will receive CPAP treatment without SensAwake™ activation for two weeks, then crossed-over to CPAP treatment with SensAwake™ activation for additional two weeks. No washout period. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Intervention (2 Weeks) |
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| Second Intervention (2 Weeks) |
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| ID | Title | Description |
|---|---|---|
| BG000 | CPAP w/SensAwake First, Then CPAP w/o SensAwake | Patients will receive CPAP treatment with SensAwake™ activation for two weeks, then crossed-over to CPAP treatment without SensAwake™ activation for additional two weeks. No washout period. |
| BG001 | CPAP w/o SensAwake First, Then CPAP w/SensAwake |
| Units | Counts |
|---|---|
| Participants |
|
| 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 | Compliance of Auto-CPAP Therapy | Objective data recorded in the auto-CPAP machine, Percentage of nights of using auto-CPAP for at least 4 hours during therapy. | Posted | Mean | Standard Deviation | percentage of nights | 2 weeks |
|
|
4 weeks
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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 | SA ON | CPAP with SensAwake activation | 0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ning-Hung, Chen | Sleep Center, Taoyuan Chang Gung Memorial Hospital | +886-3-3281200 | 2281 | ninghung@yahoo.com.tw |
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| ID | Term |
|---|---|
| D020181 | Sleep Apnea, Obstructive |
| ID | Term |
|---|---|
| D012891 | Sleep Apnea Syndromes |
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
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|
| 2 weeks |
| 90th Percentile Pressures of Auto-CPAP Machine | 90th percentile pressures of auto-CPAP machine (Objective data recorded in the auto-CPAP machine) | 2 weeks |
| Average Leaks of Auto-CPAP Machine | Average leaks of auto-CPAP machine (Objective data recorded in the auto-CPAP machine) | 2 weeks |
| 90th Percentile Leaks of Auto-CPAP Machine | Average leaks of auto-CPAP machine (Objective data recorded in the auto-CPAP machine) | 2 weeks |
| Residual Apnea-Hypopnea Index (AHI) | Residual Apnea-Hypopnea index (Objective data recorded in the auto-CPAP machine) means events of apnea and hypopnea per hour during CPAP therapy. | 2 weeks |
| Time Used of Auto-CPAP Machine | Average Time used of auto-CPAP machine (Objective data recorded in the auto-CPAP machine) | 2 weeks |
| Percentage of Day Used of Auto-CPAP Machine | Percentage of day used of auto-CPAP machine (Objective data recorded in the auto-CPAP machine) | 2 weeks |
| Pittsburgh Sleep Quality Index (PSQI) | The Pittsburgh Sleep Quality Index (PSQI) is a self-report questionnaire that assesses sleep quality over a 1-month time interval. Overall score is ranging from 0 to 21, where lower scores denote a healthier sleep quality. | 2 weeks |
| Epworth Sleepiness Score (ESS) | The ESS is a self-administered questionnaire with 8 questions. The ESS score can range from 0 to 24, where higher scores denote a worse daytime sleepiness. | 2 weeks |
| Nasal Obstruction Symptom Evaluation (NOSE) | The Nasal Obstruction Symptom Evaluation (NOSE) is a self-administered questionnaire with 11 questions. The NOSE score can range from 0 to 44, where higher scores denote a worse nasal obstruction. | 2 weeks |
| NOT COMPLETED |
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Patients will receive CPAP treatment without SensAwake™ activation for two weeks, then crossed-over to CPAP treatment with SensAwake™ activation for additional two weeks. No washout period. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Body Mass Index (BMI) | Mean | Standard Deviation | kg/m2 |
|
| Neck Circumference (NC) | Mean | Standard Deviation | cm |
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| Apnea-hypopnea index (AHI) | Apnea-hypopnea index is an index used to indicate the severity of sleep apnea. It is represented by the number of apnea and hypopnea events per hour of sleep that recorded in polysomnography. | Mean | Standard Deviation | events per hour |
|
| Sleep efficiency | Sleep efficiency is presented by percentage of minutes of sleep divided by the minutes in bed. | Mean | Standard Deviation | % (percentage of minutes slept) |
|
| Total sleep time | Mean | Standard Deviation | minutes |
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| Deep sleep - Stage 3 | Deep sleep is presented by percentage of minutes of stage 3 divided by the minutes of all sleep time. | Mean | Standard Deviation | % (percentage of minutes of stage 3) |
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| Average used time of CPAP | Mean | Standard Deviation | minutes |
|
| Compliance of CPAP | CPAP compliance is defined as using the therapy for more than 4 hours a night of all the nights. | Mean | Standard Deviation | % |
|
| Residual AHI under CPAP Tx | Apnea-hypopnea index (AHI) is an index used to indicate the severity of sleep apnea. It is represented by the number of apnea and hypopnea events per hour of sleep. Residual AHI is recorded by CPAP device. | Mean | Standard Deviation | events per hour |
|
| Pittsburgh Sleep Quality Index (PSQI) | The Pittsburgh Sleep Quality Index (PSQI) is a self-report questionnaire that assesses sleep quality over a 1-month time interval. Overall score is ranging from 0 to 21, where lower scores denote a healthier sleep quality. | Mean | Standard Deviation | units on a scale |
|
| Epworth Sleepiness Scale (ESS) | The ESS is a self-administered questionnaire with 8 questions. The ESS score can range from 0 to 24, where higher scores denote a worse daytime sleepiness. | Mean | Standard Deviation | units on a scale |
|
| Nasal Obstruction Symptom Evaluation (NOSE) | The Nasal Obstruction Symptom Evaluation (NOSE) is a self-administered questionnaire with 11 questions. The NOSE score can range from 0 to 44, where higher scores denote a worse nasal obstruction. | Mean | Standard Deviation | units on a scale |
|
|
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| Secondary | Average SA Detections | Average detects of arousal per hours. (Objective data recorded in the auto-CPAP machine) | Posted | Mean | Standard Deviation | times/hour | 2 weeks |
|
|
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| Secondary | Average Pressures of Auto-CPAP Machine | Average Pressures of Auto-CPAP Machine (Objective data recorded in the auto-CPAP machine) | Posted | Mean | Standard Deviation | cmH2O | 2 weeks |
|
|
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| Secondary | 90th Percentile Pressures of Auto-CPAP Machine | 90th percentile pressures of auto-CPAP machine (Objective data recorded in the auto-CPAP machine) | Posted | Mean | Standard Deviation | cmH2O | 2 weeks |
|
|
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| Secondary | Average Leaks of Auto-CPAP Machine | Average leaks of auto-CPAP machine (Objective data recorded in the auto-CPAP machine) | Posted | Mean | Standard Deviation | liters per minute | 2 weeks |
|
|
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| Secondary | 90th Percentile Leaks of Auto-CPAP Machine | Average leaks of auto-CPAP machine (Objective data recorded in the auto-CPAP machine) | Posted | Mean | Standard Deviation | liters per minute | 2 weeks |
|
|
|
| Secondary | Residual Apnea-Hypopnea Index (AHI) | Residual Apnea-Hypopnea index (Objective data recorded in the auto-CPAP machine) means events of apnea and hypopnea per hour during CPAP therapy. | Posted | Mean | Standard Deviation | events per hour | 2 weeks |
|
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| Secondary | Time Used of Auto-CPAP Machine | Average Time used of auto-CPAP machine (Objective data recorded in the auto-CPAP machine) | Posted | Mean | Standard Deviation | minutes | 2 weeks |
|
|
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| Secondary | Percentage of Day Used of Auto-CPAP Machine | Percentage of day used of auto-CPAP machine (Objective data recorded in the auto-CPAP machine) | Posted | Mean | Standard Deviation | Percentage of days | 2 weeks |
|
|
|
| Secondary | Pittsburgh Sleep Quality Index (PSQI) | The Pittsburgh Sleep Quality Index (PSQI) is a self-report questionnaire that assesses sleep quality over a 1-month time interval. Overall score is ranging from 0 to 21, where lower scores denote a healthier sleep quality. | Posted | Mean | Standard Deviation | units on a scale | 2 weeks |
|
|
|
| Secondary | Epworth Sleepiness Score (ESS) | The ESS is a self-administered questionnaire with 8 questions. The ESS score can range from 0 to 24, where higher scores denote a worse daytime sleepiness. | Posted | Mean | Standard Deviation | units on a scale | 2 weeks |
|
|
|
| Secondary | Nasal Obstruction Symptom Evaluation (NOSE) | The Nasal Obstruction Symptom Evaluation (NOSE) is a self-administered questionnaire with 11 questions. The NOSE score can range from 0 to 44, where higher scores denote a worse nasal obstruction. | Posted | Mean | Standard Deviation | units on a scale | 2 weeks |
|
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|
| 25 |
| 0 |
| 25 |
| 0 |
| 25 |
| EG001 | SA OFF | CPAP without SensAwake activation | 0 | 25 | 0 | 25 | 0 | 25 |
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| D020919 |
| Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |