Comparison of Two Continuous Positive Airway Pressure Systems

Not Applicable

Completed

• Conditions: Obstructive Sleep Apnoea
• Interventions: Device: Novel System; Device: Traditional System

• Registration Number: NCT02535234
• Lead Sponsor: ResMed

Brief Summary

Randomised crossover trial of a novel and traditional Continuous Positive Airway Pressure (CPAP) system in Obstructive Sleep Apnoea patients.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-08-25
• Study First Submitted QC: 2015-08-26
• Study First Posted: 2015-08-28
• Study Start: 2016-04
• Primary Completion: 2016-06
• Study Completion: 2016-06
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-02
• Last Update Posted: 2021-02-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Arm 1	Novel System	Participants randomised to Arm 1 will receive an intervention of 7 nights with the Novel system followed by 7 nights with theTraditional system
Arm 2	Novel System	Participants randomised to Arm 1 will receive an intervention of 7 nights with the Traditional system followed by 7 nights with the Novel system
Arm 1	Traditional System	Participants randomised to Arm 1 will receive an intervention of 7 nights with the Novel system followed by 7 nights with theTraditional system
Arm 2	Traditional System	Participants randomised to Arm 1 will receive an intervention of 7 nights with the Traditional system followed by 7 nights with the Novel system

Primary Outcome Measures

Name	Time	Method
Subjective usability ratings of the prototype system using a visual analogue scale, compared to a reference level and the second full system.	1 year	Participants will be asked to complete a short questionnaire at the end of each week to evaluate the general usability of the system. The questionnaire will include questions related to system use and comfort. The participants will answer the questions using an 11-point Likert scale.

Trial Locations

Locations (1)

ResMed; 🇦🇺 Sydney, New South Wales, Australia