Evaluation of APAP With SensAwake in OSA and Insomnia Patients

Study Overview
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Brief Summary
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The hypothesis is that APAP with SensAwake improves wake-after sleep onset compared to APAP without SensAwake in a patient population with Obstructive Sleep Apnea Syndrome (OSAS) and Insomnia.

Detailed Description
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Patients with OSA and Insomnia will be enrolled into this randomized study to receive treatment with APAP with and without SensAwake. Baseline data will be collected for one week prior to CPAP initiation, followed by two treatment periods on each study arm of four weeks each.

Official Title
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Evaluation of APAP With SensAwake in OSA and Insomnia Patients

Conditions
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Obstructive Sleep Apnea, Insomnia

Intervention / Treatment
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* Device: APAP
* Device: APAP with SensAwake


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Older than 18 years of age. Diagnosed with OSA and eligible for CPAP treatment under local requirements (AHI>30 with no more than 20% of central respiratory events) Naïve to CPAP therapy, i.e. have not been prescribed, or used CPAP in the last 5 years. Fluent in spoken and written French Exclusion Criteria: Significant uncontrolled cardiac disease, as per the principal investigator's discretion, and/or Left Ventricular Ejection Fraction (LVEF) < 45% Co-existing lung disease, as per the principal investigator's discretion Co-existing sleep disorder, such as predominant central sleep apnea Previous or current diagnosis of sleep phase delay Pregnancy Participants that are unable or unwilling to give informed consent Receiving cognitive behavioral therapy or other intervention to treat insomnia. Subjects may be using hypnotics, but there shall be no change in hypnotic use during the protocol or 4 weeks preceding enrolment into the study. Diagnosed with clinical depression and/or currently using anti-depressants and/or anti-anxiolytics within the last 6 months. Hospital Anxiety OR Depression score > 11 Participating in another research study for the duration of participation in this study. Participation in an observational study or genetic study is permitted at the discretion of the investigator. Patient protected by the Law, under guardianship or curators, as defined in Public Health Code in articles from L1121-5 to L1121-8. Patient not covered by a health insurance

Ages Eligible for Study
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Minimum Age: 18 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 |
| --- | --- |
| Active Comparator: APAP without SensAwake<br>Auto CPAP delivered from the ICON+ CPAP device. | Device: APAP<br>* Automatic Continuous Positive Airway Pressure<br>* Other names: ICON+ Auto;|
| Experimental: APAP with SensAwake<br>Auto CPAP with SensAwake turned on and set at a pressure of 4cmH2O. SensAwake is a pressure relief function that reduces the CPAP pressure on the transition from sleep to wake. | Device: APAP with SensAwake<br>* Automatic Continuous Positive Airway Pressure with SensAwake enabled. SensAwake is a pressure relief technology that detects the transition from sleep to wake, and promptly reduces the pressure during wakeful periods.<br>* Other names: Auto CPAP with SensAwake Pressure relief;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective Sleep Quality - Wake After Sleep Onset (WASO) | Amount of time spent awake after sleep onset, as measured by actigraphy | Four weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective Sleep Quality - Total Sleep Time | Total sleep time, as measured by actigraphy - nightly average | Four weeks | 
| Objective Sleep Quality - Sleep Onset Latency | Time it takes to fall asleep, as measured by actigraphy - nightly average | Four weeks | 
| Objective Sleep Quality - Sleep efficiency | Percentage of time in bed spent asleep, as measured by actigraphy - nightly average | Four weeks | 
| Treatment compliance | Time spent on CPAP treatment - nightly average | Four weeks | 
| Subjective sleep quality - Pittsburgh Sleep Quality Index | Questionnaire | Four weeks | 
| Insomnia severity - Insomnia Severity Index | Questionnaire | Four weeks | 
| Daytime sleepiness - Epworth Sleepiness Score | Questionnaire | Four weeks | 
| Quality of Life - Short Form 12 | Questionnaire | Four weeks | 
| Blood pressure | Measured by 24 hour ambulatory blood pressure | 24 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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OSA, Obstructive Sleep Apnea, Insomnia, CPAP, SensAwake