Usability Evaluation of Menai CPAP Masks
Menai Mask Systems - Clinical Study 1
1 other identifier
interventional
30
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started May 2015
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 1, 2015
CompletedFirst Posted
Study publicly available on registry
February 18, 2015
CompletedStudy Start
First participant enrolled
May 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2015
CompletedFebruary 4, 2021
February 1, 2021
2 months
February 1, 2015
February 2, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Usability Performance Evaluation
Evaluation of the usability performance (seal, comfort, etc) of the Menai masks, compared to the Comparison Menai Standard masks.
2 weeks
Secondary Outcomes (1)
Humidification Performance Evaluation
2 weeks
Study Arms (3)
Full Face
EXPERIMENTALParticipants 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
EXPERIMENTALParticipants 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
EXPERIMENTALParticipants 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.
Interventions
Prototype mask system (full face variant) with novel vent and humidification system
Prototype mask system (full face variant) with conventional vent and humidification system
Prototype mask system (nasal variant) with novel vent and humidification system
Prototype mask system (nasal variant) with conventional vent and humidification system
Prototype mask system (pillows variant) with conventional vent and humidification system
Prototype mask system (pillows variant) with conventional vent and humidification system
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- ResMedlead
Study Sites (1)
ResMed Sleep Research Centre
Sydney, New South Wales, 2153, Australia
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- 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 Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 1, 2015
First Posted
February 18, 2015
Study Start
May 1, 2015
Primary Completion
July 1, 2015
Study Completion
July 1, 2015
Last Updated
February 4, 2021
Record last verified: 2021-02