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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
35
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.
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.
Time frame: 2 weeks
Average SA Detections
Average detects of arousal per hours. (Objective data recorded in the auto-CPAP machine)
Time frame: 2 weeks
Average Pressures of Auto-CPAP Machine
Average Pressures of Auto-CPAP Machine (Objective data recorded in the auto-CPAP machine)
Time frame: 2 weeks
90th Percentile Pressures of Auto-CPAP Machine
90th percentile pressures of auto-CPAP machine (Objective data recorded in the auto-CPAP machine)
Time frame: 2 weeks
Average Leaks of Auto-CPAP Machine
Average leaks of auto-CPAP machine (Objective data recorded in the auto-CPAP machine)
Time frame: 2 weeks
90th Percentile Leaks of Auto-CPAP Machine
Average leaks of auto-CPAP machine (Objective data recorded in the auto-CPAP machine)
Time frame: 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.
Time frame: 2 weeks
Time Used of Auto-CPAP Machine
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Average Time used of auto-CPAP machine (Objective data recorded in the auto-CPAP machine)
Time frame: 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)
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 2 weeks