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Conceptually, awareness of pressure occurs only during wakefulness. Thus reducing the pressure during wakefulness may improve therapy comfort and potentially adherence without compromizing therapy efficacy. SensAwake™ is a unique pressure relief technology developed by Fisher & Paykel Healthcare which detects irregularity in the flow signal indicative of the transition from sleep to wake. When the transition from sleep to wake is detected the device promptly reduces the pressure to help facilitate a return to sleep.
The purpose of this study is to compare adherence and sleep quality outcomes in patients treated by CPAP with and without SensAwake technology.
It is hypothesised that participants with SensAwake on will have improved adherence and sleep quality.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SensAwake On | Experimental | The comfort feature 'SensAwake' will be turned on |
|
| SensAwake Off | Active Comparator | The comfort feature 'SensAwake' will be turned off |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SensAwake On | Device |
| ||
| SensAwake Off |
| Measure | Description | Time Frame |
|---|---|---|
| Adherence to CPAP Treatment | Average used minutes (all days) taken from the CPAP device. | 2 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Daytime Sleepiness (Subjective Sleep Quality) | Collected through the Epworth Sleepiness Scale (ESS) which is a subjective questionnaire and the participant answer 8 question with rating on the chance of dozing (from 0= no chance of dozing to 3 = high chance of dozing). The total is added with a range from 0-24. A total score of 0 means that the participant is not experiencing day time sleepiness, while total score of 24 means that the participant si extremely sleepy during the daytime. |
| Measure | Description | Time Frame |
|---|---|---|
| Leak | The amount of Continuous Positive Airway Pressure (CPAP) leak was obtained through the device | One night |
| Apnea Hypopnea Index (AHI) | Collected through the device |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pulmonary Associates | Glendale | Arizona | 85306 | United States | ||
| SleepMed of Central Georgia |
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| ID | Title | Description |
|---|---|---|
| FG000 | SensAwake On, Then Followed by SensAwake Off | The comfort feature 'SensAwake' will be turned on, followed by it off. |
| FG001 | SensAwake Off, Then Followed by SensAwake On | The comfort feature 'SensAwake' will be turned off, then followed by on. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | All Study Participants | Participants who were randomized to receive either SensAwake On or SensAwake Off |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Only collected 65 participants data on age |
| 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 | Adherence to CPAP Treatment | Average used minutes (all days) taken from the CPAP device. | Adherence data could only be obtained for 61 participants | Posted | Mean | Standard Error | mins | 2 weeks |
|
|
1 year and 1 month
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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 | SensAwake On | The comfort feature 'SensAwake' will be turned on | 0 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| High Blood Pressure | Blood and lymphatic system disorders | Non-systematic Assessment | Participant was hospitalized with symptoms of extremely high blood pressure. No formal diagnosis was given prior to discharge however subjects were placed on hypertension medication. PI deemed as not related to the device |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Mask related issues | Skin and subcutaneous tissue disorders | Non-systematic Assessment | 11 events were related to the mask, it was not related to the device. There were sore on nose, skin breakdown from mask and mask irritations |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Richard Bogan | SleepMed of South Carolina | 8777537633 | rbogan@sleepmedinc.com |
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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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|
| 4 weeks |
| Insomnia Severity Index (Subjective Sleep Quality) | Collected through the Insomnia Severity Index (ISI). There are seven question with each question having a scale of 0 (no issue) to 4 (very severe). The total score is added up. If the participant has a total score of 0-7 = no clinical significant insomnia, total score of 8-14 = sub threshold insomnia, total score of 15-21 = clinical insomnia (moderate), total score of 22-28 = clinical insomnia (severe). | 4 weeks |
| OSA Impact of Daily Life | Collected through the Short Functional Outcomes of Sleep Questionnaire (FOSQ-10). The questionnaire has 10 questions which ask how daytime sleepiness has impacted their quality of life. Each question has a scale of 1 = yes extreme to 4 = No. Lower total score (min 10) means that the disease is affecting your quality of life while a higher total score (maximum 40) means that the disease is not affecting your quality of life. | 4 weeks |
| OSA Impact of Daily Life (Fatigue) | Collected through the Fatigue Severity Scale (FSS). There are 9 question on fatigue with each question having a scale of 1 = strongly disagree and 7 = strongly agree. A lower total score (minimum of 9) = low severity with fatigue while a higher total score (maximum of 63) indicates a higher severity with fatigue. | 4 weeks |
| Subjective Treatment Efficacy - Patient Global Impression of Change (PGI) - Severity | Collected through the Patient Global Impression of Change (PGI).The questions ask "Since beginning CPAP therapy, how would you describe the chance (if any) in symptoms related to your OSA. The questions has a scale of 1 = no change (or condition has got worse) to 7 = a great deal better and a considerable improvement that has made all the difference. | 4 weeks |
| Subjective Treatment Efficacy - Patient Global Impression of Change (PGI) - Change | Collected through the Patient Global Impression of Change (PGI).The questions ask "Since beginning CPAP therapy, how would you describe the change (if any) in overall quality of life related to your OSA?". The questions has a scale of 1 = no change (or condition has got worse) to 7 = a great deal better and a considerable improvement that has made all the difference. | 4 weeks |
| 2 weeks |
| Macon |
| Georgia |
| United States |
| Sleep Med of South Carolina | Columbia | South Carolina | United States |
| Mean |
| Standard Deviation |
| years |
|
| Sex: Female, Male | Only collected n=68. Missing data for 2 participants. | Count of Participants | Participants |
|
| Participants |
|
|
| Secondary | Daytime Sleepiness (Subjective Sleep Quality) | Collected through the Epworth Sleepiness Scale (ESS) which is a subjective questionnaire and the participant answer 8 question with rating on the chance of dozing (from 0= no chance of dozing to 3 = high chance of dozing). The total is added with a range from 0-24. A total score of 0 means that the participant is not experiencing day time sleepiness, while total score of 24 means that the participant si extremely sleepy during the daytime. | Data for 65 participant were available | Posted | Mean | Standard Error | units on a scale | 4 weeks |
|
|
|
| Secondary | Insomnia Severity Index (Subjective Sleep Quality) | Collected through the Insomnia Severity Index (ISI). There are seven question with each question having a scale of 0 (no issue) to 4 (very severe). The total score is added up. If the participant has a total score of 0-7 = no clinical significant insomnia, total score of 8-14 = sub threshold insomnia, total score of 15-21 = clinical insomnia (moderate), total score of 22-28 = clinical insomnia (severe). | Data for 63 participant were available | Posted | Mean | Standard Error | units on a scale | 4 weeks |
|
|
|
| Secondary | OSA Impact of Daily Life | Collected through the Short Functional Outcomes of Sleep Questionnaire (FOSQ-10). The questionnaire has 10 questions which ask how daytime sleepiness has impacted their quality of life. Each question has a scale of 1 = yes extreme to 4 = No. Lower total score (min 10) means that the disease is affecting your quality of life while a higher total score (maximum 40) means that the disease is not affecting your quality of life. | Data for 62 participant were available | Posted | Mean | Standard Error | units on a scale | 4 weeks |
|
|
|
| Secondary | OSA Impact of Daily Life (Fatigue) | Collected through the Fatigue Severity Scale (FSS). There are 9 question on fatigue with each question having a scale of 1 = strongly disagree and 7 = strongly agree. A lower total score (minimum of 9) = low severity with fatigue while a higher total score (maximum of 63) indicates a higher severity with fatigue. | Data for 64 participant were available | Posted | Mean | Standard Error | units on a scale | 4 weeks |
|
|
|
| Secondary | Subjective Treatment Efficacy - Patient Global Impression of Change (PGI) - Severity | Collected through the Patient Global Impression of Change (PGI).The questions ask "Since beginning CPAP therapy, how would you describe the chance (if any) in symptoms related to your OSA. The questions has a scale of 1 = no change (or condition has got worse) to 7 = a great deal better and a considerable improvement that has made all the difference. | Data for 64 participant were available | Posted | Mean | Standard Error | units on a scale | 4 weeks |
|
|
|
| Other Pre-specified | Leak | The amount of Continuous Positive Airway Pressure (CPAP) leak was obtained through the device | Obtained only 61 participant CPAP data. | Posted | Mean | Standard Error | L/min | One night |
|
|
|
| Other Pre-specified | Apnea Hypopnea Index (AHI) | Collected through the device | Only 61 participant data was available. | Posted | Mean | Standard Error | events/hour | 2 weeks |
|
|
|
| Post-Hoc | Adherence in Patients With Signs of Moderate Clinical Insomnia | Adherence from the device (during their first treatment arm) in patients with moderate clinical insomnia (Insomnia Severity Index 15 or over) | Only participant with moderate clinical insomnia (Insomnia Severity Index of 15 and over) were included in the post-hoc. | Posted | Mean | Standard Error | minutes | 4 weeks |
|
|
|
| Post-Hoc | Adherence in Patients With Signs of Moderate Clinical Insomnia | Adherence from the device (during their entire study period) in patients with moderate clinical insomnia (Insomnia Severity Index 15 or over) | Only participant with moderate clinical insomnia (Insomnia Severity Index of 15 and over) were included in the post-hoc. | Posted | Mean | Standard Error | minutes | 8 weeks |
|
|
|
| Secondary | Subjective Treatment Efficacy - Patient Global Impression of Change (PGI) - Change | Collected through the Patient Global Impression of Change (PGI).The questions ask "Since beginning CPAP therapy, how would you describe the change (if any) in overall quality of life related to your OSA?". The questions has a scale of 1 = no change (or condition has got worse) to 7 = a great deal better and a considerable improvement that has made all the difference. | Data for 64 participant were available | Posted | Mean | Standard Error | units on a scale | 4 weeks |
|
|
|
| 70 |
| 0 |
| 70 |
| 11 |
| 70 |
| EG001 | SensAwake Off | The comfort feature 'SensAwake' will be turned off | 0 | 70 | 1 | 70 | 16 | 70 |
|
|
| Cold or Upper Respiratory Infections | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment | Cold or Upper Respiratory Infections. They were not related to the device |
|
| Broken Arm | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | Broken Arm not related to the device |
|
| Dizziness upon Arousal | Blood and lymphatic system disorders | Non-systematic Assessment | Not related to the device |
|
| Pressure related problems | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment | Feeling higher pressure from the device |
|
| Scheduled Achilles Tendon Surgery | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | Not related to the device |
|
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| D020919 |
| Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |