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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT02364375




Registration number
NCT02364375
Ethics application status
Date submitted
1/02/2015
Date registered
18/02/2015
Date last updated
4/02/2021

Titles & IDs
Public title
Usability Evaluation of Menai CPAP Masks
Scientific title
Menai Mask Systems - Clinical Study 1
Secondary ID [1] 0 0
MA220115
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obstructive Sleep Apnea 0 0
Condition category
Condition code
Respiratory 0 0 0 0
Sleep apnoea

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - Menai mask (full face)
Treatment: Devices - Menai Standard mask (full face)
Treatment: Devices - Menai mask (nasal)
Treatment: Devices - Menai Standard mask (nasal)
Treatment: Devices - Menai mask (pillows)
Treatment: Devices - Menai Standard mask (pillows)

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.

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.

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.


Treatment: Devices: Menai mask (full face)
Prototype mask system (full face variant) with novel vent and humidification system

Treatment: Devices: Menai Standard mask (full face)
Prototype mask system (full face variant) with conventional vent and humidification system

Treatment: Devices: Menai mask (nasal)
Prototype mask system (nasal variant) with novel vent and humidification system

Treatment: Devices: Menai Standard mask (nasal)
Prototype mask system (nasal variant) with conventional vent and humidification system

Treatment: Devices: Menai mask (pillows)
Prototype mask system (pillows variant) with conventional vent and humidification system

Treatment: Devices: Menai Standard mask (pillows)
Prototype mask system (pillows variant) with conventional vent and humidification system
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Usability Performance Evaluation
Timepoint [1] 0 0
2 weeks
Secondary outcome [1] 0 0
Humidification Performance Evaluation
Timepoint [1] 0 0
2 weeks

Eligibility
Key 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
Minimum age
18 Years
Maximum age
90 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Supportive Care
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/05/2015
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/07/2015
Sample size
Target
Accrual to date
Final
30
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
ResMed Sleep Research Centre - Sydney
Recruitment postcode(s) [1] 0 0
2153 - Sydney

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
ResMed
Address
Country

Ethics approval
Ethics application status

Summary
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 website
https://clinicaltrials.gov/ct2/show/NCT02364375
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Klaus Schindhelm, BE PhD
Address 0 0
Graduate School of Biomedical Engineering, University of New South Wales, Sydney Australia and Applied Research, ResMed Ltd Sydney Australia
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT02364375