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Usability Evaluation of Menai CPAP Masks

Primary Purpose

Obstructive Sleep Apnea

Status
Completed
Phase
Not Applicable
Locations
Australia
Study Type
Interventional
Intervention
Menai mask (full face)
Menai Standard mask (full face)
Menai mask (nasal)
Menai Standard mask (nasal)
Menai mask (pillows)
Menai Standard mask (pillows)
Sponsored by
ResMed
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Obstructive Sleep Apnea focused on measuring sleep, apnea, OSA, CPAP

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • ResMed Sleep Research Centre

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Full Face

Nasal

Pillows

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Humidification Performance Evaluation
Evaluation of the humidification performance of the Menai masks (passive humidification), compared to the Comparison Menai Standard masks (active humidification).

Full Information

First Posted
February 1, 2015
Last Updated
February 2, 2021
Sponsor
ResMed
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1. Study Identification

Unique Protocol Identification Number
NCT02364375
Brief Title
Usability Evaluation of Menai CPAP Masks
Official Title
Menai Mask Systems - Clinical Study 1
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
May 2015 (Actual)
Primary Completion Date
July 2015 (Actual)
Study Completion Date
July 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ResMed

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstructive Sleep Apnea
Keywords
sleep, apnea, OSA, CPAP

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Full Face
Arm Type
Experimental
Arm Description
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.
Arm Title
Nasal
Arm Type
Experimental
Arm Description
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.
Arm Title
Pillows
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Menai mask (full face)
Intervention Description
Prototype mask system (full face variant) with novel vent and humidification system
Intervention Type
Device
Intervention Name(s)
Menai Standard mask (full face)
Intervention Description
Prototype mask system (full face variant) with conventional vent and humidification system
Intervention Type
Device
Intervention Name(s)
Menai mask (nasal)
Intervention Description
Prototype mask system (nasal variant) with novel vent and humidification system
Intervention Type
Device
Intervention Name(s)
Menai Standard mask (nasal)
Intervention Description
Prototype mask system (nasal variant) with conventional vent and humidification system
Intervention Type
Device
Intervention Name(s)
Menai mask (pillows)
Intervention Description
Prototype mask system (pillows variant) with conventional vent and humidification system
Intervention Type
Device
Intervention Name(s)
Menai Standard mask (pillows)
Intervention Description
Prototype mask system (pillows variant) with conventional vent and humidification system
Primary Outcome Measure Information:
Title
Usability Performance Evaluation
Description
Evaluation of the usability performance (seal, comfort, etc) of the Menai masks, compared to the Comparison Menai Standard masks.
Time Frame
2 weeks
Secondary Outcome Measure Information:
Title
Humidification Performance Evaluation
Description
Evaluation of the humidification performance of the Menai masks (passive humidification), compared to the Comparison Menai Standard masks (active humidification).
Time Frame
2 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Klaus Schindhelm, BE PhD
Organizational Affiliation
Graduate School of Biomedical Engineering, University of New South Wales, Sydney Australia and Applied Research, ResMed Ltd Sydney Australia
Official's Role
Principal Investigator
Facility Information:
Facility Name
ResMed Sleep Research Centre
City
Sydney
State/Province
New South Wales
ZIP/Postal Code
2153
Country
Australia

12. IPD Sharing Statement

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Usability Evaluation of Menai CPAP Masks

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