Usability Evaluation of Menai CPAP Masks

February 2, 2021 updated by: ResMed

Menai Mask Systems - Clinical Study 1

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • New South Wales
      • Sydney, New South Wales, Australia, 2153
        • ResMed Sleep Research Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Device: Menai mask (full face)
Prototype mask system (full face variant) with novel vent and humidification system
Device: Menai Standard mask (full face)
Prototype mask system (full face variant) with conventional vent and humidification system
Experimental: 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.
Device: Menai mask (nasal)
Prototype mask system (nasal variant) with novel vent and humidification system
Device: Menai Standard mask (nasal)
Prototype mask system (nasal variant) with conventional vent and humidification system
Experimental: 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.
Device: Menai mask (pillows)
Prototype mask system (pillows variant) with conventional vent and humidification system
Device: Menai Standard mask (pillows)
Prototype mask system (pillows variant) with conventional vent and humidification system

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Usability Performance Evaluation
Time Frame: 2 weeks
Evaluation of the usability performance (seal, comfort, etc) of the Menai masks, compared to the Comparison Menai Standard masks.
2 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Humidification Performance Evaluation
Time Frame: 2 weeks
Evaluation of the humidification performance of the Menai masks (passive humidification), compared to the Comparison Menai Standard masks (active humidification).
2 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ResMed

Investigators

  • Principal Investigator: Klaus Schindhelm, BE PhD, Graduate School of Biomedical Engineering, University of New South Wales, Sydney Australia and Applied Research, ResMed Ltd Sydney Australia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2015

Primary Completion (Actual)

July 1, 2015

Study Completion (Actual)

July 1, 2015

Study Registration Dates

First Submitted

February 1, 2015

First Submitted That Met QC Criteria

February 17, 2015

First Posted (Estimate)

February 18, 2015

Study Record Updates

Last Update Posted (Actual)

February 4, 2021

Last Update Submitted That Met QC Criteria

February 2, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MA220115

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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