Comparison Study of the ICON™ CPAP Series With and Without SensAwake™

Study Overview
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Brief Summary
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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.

Conditions
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Obstructive Sleep Apnea

Intervention / Treatment
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* Device: SensAwake On
* Device: SensAwake Off


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Aged 18-75 years with moderate-to-severe OSA (AHI equal to or greater than 10 per hour). Successful in-lab titration polysomnography (PSG) General (at home) sleep habits of: At least 7 hours in bed on most nights Lights out at 12 midnight or earlier Fluency in both written and spoken English. Exclusion Criteria: Participants prescribed and fitted with any PAP device in the past 2 years Contraindicated for CPAP or AutoCPAP therapy. Any known factor or disease that might interfere with treatment adherence, study conduct or interpretation of the results such as severe psychiatric disease, history of non adherence to medical regimens, or unwillingness to comply with study requirements as determined by the principal investigator. Other significant sleep disorder(s) that would interfere with their ability to wear CPAP as determined by the principal investigator. Patients who are prescribed hypnotics and sedating medications. Any surgery of the mouth, nose, sinuses or airways (for OSA, snoring or otherwise) in the past 12 months. If participants are required, by the nature of their employment, to comply with therapy. For example truck drivers or airline pilots. If the physician objects to their patient taking part in the study.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SensAwake On<br>The comfort feature 'SensAwake' will be turned on | Device: SensAwake On<br> <br> |
| Active Comparator: SensAwake Off<br>The comfort feature 'SensAwake' will be turned off | Device: SensAwake Off<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adherence to CPAP Treatment | Average used minutes (all days) taken from the CPAP device. | 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | 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. | 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 |