Obstructive Sleep ApneaNCT02364375
Usability Evaluation of Menai CPAP Masks
A study testing Menai mask (full face), Menai Standard mask (full face) and Menai mask (nasal) in people with Obstructive Sleep Apnea, run by ResMed at 1 site in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Obstructive Sleep Apnea
- What is being tested?
- Menai mask (full face), Menai Standard mask (full face) and Menai mask (nasal)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteAustralia
- Study dates
- May 2015to Jul 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Obstructive Sleep Apnea
- Being tested
- Menai mask (full face), Menai Standard mask (full face), Menai mask (nasal), Menai Standard mask (nasal), Menai mask (pillows)
- Keywords
- sleep, apnea, OSA, CPAP
- Medical subject headings
- Sleep Apnea, Obstructive, Apnea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Menai mask (full face)Device
Prototype mask system (full face variant) with novel vent and humidification system
Menai Standard mask (full face)Device
Prototype mask system (full face variant) with conventional vent and humidification system
Menai mask (nasal)Device
Prototype mask system (nasal variant) with novel vent and humidification system
Menai Standard mask (nasal)Device
Prototype mask system (nasal variant) with conventional vent and humidification system
Menai mask (pillows)Device
Prototype mask system (pillows variant) with conventional vent and humidification system
Menai Standard mask (pillows)Device
Prototype mask system (pillows variant) with conventional vent and humidification system
| Study group | Role | What they receive |
|---|---|---|
| Full Face | Experimental | 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. Receives: Device: Menai mask (full face); Device: Menai Standard mask (full face) |
| Nasal | Experimental | 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. Receives: Device: Menai mask (nasal); Device: Menai Standard mask (nasal) |
| Pillows | Experimental | 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. Receives: Device: Menai mask (pillows); Device: Menai Standard mask (pillows) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Usability Performance Evaluation
Evaluation of the usability performance (seal, comfort, etc) of the Menai masks, compared to the Comparison Menai Standard masks.
Measured: 2 weeks
Secondary outcomes (1)
Humidification Performance Evaluation
Evaluation of the humidification performance of the Menai masks (passive humidification), compared to the Comparison Menai Standard masks (active humidification).
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2015 (estimated)
- Study startMay 2015
- Primary completionJul 2015
- Study completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstructive Sleep ApneaStudies of the same condition, open and under way.
- More trials run by ResMedThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- ResMed
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Klaus Schindhelm, BE PhD, Principal investigator, Graduate School of Biomedical Engineering, University of New South Wales, Sydney Australia and Applied Research, ResMed Ltd Sydney Australia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02364375
- Sponsor's protocol ID
- MA220115
- Status last verified
- Feb 2021
- First submitted
- 1 Feb 2015
- Last updated
- 4 Feb 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Menai Mask Systems - Clinical Study 1
- ClinicalTrials.gov ID
- NCT02364375
- Acronym / sponsor ID
- MA220115
- Conditions
- Obstructive Sleep Apnea
- Keywords
- sleep, apnea, OSA, CPAP
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- ResMedIndustry (pharma, biotech, devices)
- Study start
- May 2015 (actual)
- Primary completion
- Jul 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 18 Feb 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Full Face | Experimental | Device: Menai mask (full face), Device: 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. |
| Nasal | Experimental | Device: Menai mask (nasal), Device: 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 | Experimental | Device: Menai mask (pillows), Device: 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. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (8 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Menai mask (full face)Prototype mask system (full face variant) with novel vent and humidification system | Device | Full Face |
| Menai Standard mask (full face)Prototype mask system (full face variant) with conventional vent and humidification system | Device | Full Face |
| Menai mask (nasal)Prototype mask system (nasal variant) with novel vent and humidification system | Device | Nasal |
| Menai Standard mask (nasal)Prototype mask system (nasal variant) with conventional vent and humidification system | Device | Nasal |
| Menai mask (pillows)Prototype mask system (pillows variant) with conventional vent and humidification system | Device | Pillows |
| Menai Standard mask (pillows)Prototype mask system (pillows variant) with conventional vent and humidification system | Device | Pillows |
Primary outcome
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.
1 secondary outcome
Humidification Performance Evaluation
Time frame: 2 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Klaus Schindhelm, BE PhD principal investigator
Graduate School of Biomedical Engineering, University of New South Wales, Sydney Australia and Applied Research, ResMed Ltd Sydney Australia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Menai mask (full face), Menai Standard mask (full face) and Menai mask (nasal) in people with Obstructive Sleep Apnea, run by ResMed at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Usability Performance Evaluation (time frame: 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2021.