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

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

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.

Study Overview

• Status: Completed
• Conditions: Obstructive Sleep Apnea
• Intervention / Treatment: Device: SensAwake™ modification

• Study Type: Interventional
• Enrollment (Actual): 35
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
NO_INTERVENTION: APAP begins without SensAwake; 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; 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; 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Chang Gung Memorial Hospital
• Collaborators: Fisher and Paykel Healthcare
• Investigators: Principal Investigator: Li-Pang Chuang, MD, ChangGungMemorialHospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 1, 2015
• Primary Completion (ACTUAL): March 1, 2016
• Study Completion (ACTUAL): March 1, 2016

Study Registration Dates

• First Submitted: August 5, 2015
• First Submitted That Met QC Criteria: September 26, 2017
• First Posted (ACTUAL): September 27, 2017

Study Record Updates

• Last Update Posted (ACTUAL): June 12, 2018
• Last Update Submitted That Met QC Criteria: May 11, 2018
• Last Verified: June 1, 2017

More Information

Terms related to this study

• Keywords: cPAP; SenseAwake
• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Signs and Symptoms, Respiratory; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Apnea
• Other Study ID Numbers: 103-7083B