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

Chang Gung Medical Foundation

Status: Completed

Conditions: Obstructive Sleep Apnea

Treatments: Device: SensAwake™ modification

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03294629

103-7083B

Details and patient eligibility

About

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.

Enrollment: 35 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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35 participants in 2 patient groups

APAP begins without SensAwake

No Intervention group

Description:

Patients will receive CPAP treatment without SensAwake™ activation for two weeks, then crossed-over to CPAP treatment with SensAwake™ activation for additional two weeks.

APAP begins with SensAwake

Experimental group

Description:

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.

Treatment:

Device: SensAwake™ modification