The Effectiveness of SensAwake™ for Continue Positive Airway Pressure Treatment of Obstructive Sleep Apnea Patients

Study Overview
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Brief Summary
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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.

Official Title
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Effects of Pressure Control Device (SensAwake™) on Obstructive Sleep Apnea (OSA) Patients Who Remove the Mask for Unknown Reasons During Automatic Continuous Positive Airway Pressure (Auto-CPAP) Therapy

Conditions
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Obstructive Sleep Apnea

Intervention / Treatment
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* Device: SensAwake™ modification


Participation Criteria
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Eligibility Criteria
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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: Unstable cardiovascular disease (untreated or resistant hypertension acceptable). Inability to tolerate CPAP due to nasal obstruction or claustrophobia as determined by the study investigator. Any known factor or disease that might interfere with treatment compliance, study conduct or interpretation of the results such as psychiatric disease, history of non compliance to medical regimens, or unwillingness to comply with study requirements. Any known factor that result in mask taken of such as skin discomfort, nasal obstruction, water dripping inside the tubing system etc.

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 |
| --- | --- |
| No Intervention: APAP begins without SensAwake<br>Patients will receive CPAP treatment without SensAwake™ activation for two weeks, then crossed-over to CPAP treatment with SensAwake™ activation for additional two weeks. | |
| Experimental: APAP begins with SensAwake<br>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. | Device: SensAwake™ modification<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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) | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cPAP, SenseAwake