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

Not Applicable

Completed

• Conditions: Obstructive Sleep Apnea
• Interventions: Device: SensAwake™ modification

• 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

Study Timeline

• Study Start: 2015-03
• Study First Submitted: 2015-08-05
• Primary Completion: 2016-03
• Study Completion: 2016-03
• Status Verified: 2017-06
• Study First Submitted QC: 2017-09-26
• Study First Posted: 2017-09-27
• Results First Submitted: 2018-03-12
• Results First Submitted QC: 2018-05-11
• Last Update Submitted: 2018-05-11
• Results First Posted: 2018-06-12
• Last Update Posted: 2018-06-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 35

Inclusion Criteria

1. Participants will be recruited from OSA patients who will remove CPAP himself without any notable reasons.

Exclusion Criteria

1. Unstable cardiovascular disease (untreated or resistant hypertension acceptable).
2. Inability to tolerate CPAP due to nasal obstruction or claustrophobia as determined by the study investigator.
3. 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.
4. 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

Arm && Interventions

Group	Intervention	Description
APAP begins with SensAwake	SensAwake™ modification	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.

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
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)
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.