The Effectiveness of SensAwake™ for Continue Positive Airway Pressure Treatment of Obstructive Sleep Apnea Patients
- Conditions
- Obstructive Sleep Apnea
- Registration Number
- NCT03294629
- Lead Sponsor
- Chang Gung Memorial Hospital
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 35
- Participants will be recruited from OSA patients who will remove CPAP himself without any notable reasons.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Primary Outcome Measures
Name Time Method Compliance of Auto-CPAP Therapy 2 weeks Objective data recorded in the auto-CPAP machine, Percentage of nights of using auto-CPAP for at least 4 hours during therapy.
- Secondary Outcome Measures
Name Time Method Average SA Detections 2 weeks Average detects of arousal per hours. (Objective data recorded in the auto-CPAP machine)
Average Leaks of Auto-CPAP Machine 2 weeks Average leaks of auto-CPAP machine (Objective data recorded in the auto-CPAP machine)
90th Percentile Leaks of Auto-CPAP Machine 2 weeks Average leaks of auto-CPAP machine (Objective data recorded in the auto-CPAP machine)
Average Pressures of Auto-CPAP Machine 2 weeks Average Pressures of Auto-CPAP Machine (Objective data recorded in the auto-CPAP machine)
Pittsburgh Sleep Quality Index (PSQI) 2 weeks 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.
Nasal Obstruction Symptom Evaluation (NOSE) 2 weeks 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.
Residual Apnea-Hypopnea Index (AHI) 2 weeks Residual Apnea-Hypopnea index (Objective data recorded in the auto-CPAP machine) means events of apnea and hypopnea per hour during CPAP therapy.
Percentage of Day Used of Auto-CPAP Machine 2 weeks Percentage of day used of auto-CPAP machine (Objective data recorded in the auto-CPAP machine)
Epworth Sleepiness Score (ESS) 2 weeks 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.
90th Percentile Pressures of Auto-CPAP Machine 2 weeks 90th percentile pressures of auto-CPAP machine (Objective data recorded in the auto-CPAP machine)
Time Used of Auto-CPAP Machine 2 weeks Average Time used of auto-CPAP machine (Objective data recorded in the auto-CPAP machine)