Usability Evaluation of Menai CPAP Masks

Not Applicable

Completed

• Conditions: Obstructive Sleep Apnea
• Interventions: Device: Menai mask (nasal); Device: Menai mask (full face); Device: Menai mask (pillows); Device: Menai Standard mask (pillows); Device: Menai Standard mask (nasal); Device: Menai Standard mask (full face)

• Registration Number: NCT02364375
• Lead Sponsor: ResMed

Brief Summary

The primary objective of this study is to evaluate the subjective performance of the Menai mask systems (full face, nasal, and pillows variants), compared against Comparison mask systems.

Detailed Description

The study will evaluate the subjective seal, comfort, stability, usability, and humidification performance of the prototype mask systems in CPAP established patients. The performance of the prototype Menai mask systems (full face, nasal, and pillows variants) will be subjectively assessed through user questionnaires based on an 11-point Likert scale, and will be compared against Comparison masks.

The prototype masks share the same parts (cushion, frame, headgear), with the difference being that the Menai masks feature a novel vent and humidification system.

Study Timeline

• Study First Submitted: 2015-02-01
• Study First Submitted QC: 2015-02-17
• Study First Posted: 2015-02-18
• Study Start: 2015-05
• Primary Completion: 2015-07
• Study Completion: 2015-07
• 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

• Participants willing to provide written informed consent
• Participants who can read and comprehend written and spoken English
• Participants who are over 18 years of age
• Participants who have been diagnosed with OSA
• Participants who have been established on CPAP for ≥ 6 months
• Participants who are currently using the same mask type/variant as the interventional mask system to be evaluated

Exclusion Criteria

• Participants who are not able to provide written informed consent
• Participants who are unable to comprehend written and spoken English
• Participants who are pregnant
• Participants who are unsuitable to participate in the study in the opinion of the researcher
• Participants with a pre-existing lung disease or a condition that would predispose them to pneumothorax (e.g. COPD, lung cancer; fibrosis of the lungs; recent (< 2years) case of pneumonia or lung infection, lung injury)
• Participants who cannot participate for the duration of the trial
• Participants who are established on bi-level support therapy
• Participants who are not currently using the same mask type/variant as the interventional mask system to be evaluated

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Nasal	Menai mask (nasal)	Participants will trial the same mask type/variant (full face, nasal, pillows) as the variant they are using as part of their current treatment. Participants in this arm will trial the Menai mask (nasal) and Comparison Menai Standard mask (nasal) for 7 nights each.
Pillows	Menai Standard mask (pillows)	Participants will trial the same mask type/variant (full face, nasal, pillows) as the variant they are using as part of their current treatment. Participants in this arm will trial the Menai mask (pillows) and Comparison Menai Standard mask (pillows) for 7 nights each.
Full Face	Menai mask (full face)	Participants will trial the same mask type/variant (full face, nasal, pillows) as the variant they are using as part of their current treatment. Participants in this arm will trial the Menai mask (full face) and Comparison Menai Standard mask (full face) for 7 nights each.
Nasal	Menai Standard mask (nasal)	Participants will trial the same mask type/variant (full face, nasal, pillows) as the variant they are using as part of their current treatment. Participants in this arm will trial the Menai mask (nasal) and Comparison Menai Standard mask (nasal) for 7 nights each.
Pillows	Menai mask (pillows)	Participants will trial the same mask type/variant (full face, nasal, pillows) as the variant they are using as part of their current treatment. Participants in this arm will trial the Menai mask (pillows) and Comparison Menai Standard mask (pillows) for 7 nights each.
Full Face	Menai Standard mask (full face)	Participants will trial the same mask type/variant (full face, nasal, pillows) as the variant they are using as part of their current treatment. Participants in this arm will trial the Menai mask (full face) and Comparison Menai Standard mask (full face) for 7 nights each.

Primary Outcome Measures

Name	Time	Method
Usability Performance Evaluation	2 weeks	Evaluation of the usability performance (seal, comfort, etc) of the Menai masks, compared to the Comparison Menai Standard masks.

Secondary Outcome Measures

Name	Time	Method
Humidification Performance Evaluation	2 weeks	Evaluation of the humidification performance of the Menai masks (passive humidification), compared to the Comparison Menai Standard masks (active humidification).

Trial Locations

Locations (1)

ResMed Sleep Research Centre; 🇦🇺 Sydney, New South Wales, Australia