An interventional study of Menai mask (full face) and Menai Standard mask (full face) in Obstructive Sleep Apnea, sponsored by ResMed. Completed at 1 site in Australia. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2021-02-04.
Sponsored by ResMed · Not applicable, Interventional, and Supportive care
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.
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.
2,198 studies on the registry are indexed under Sleep Apnea, Obstructive; 469 are open to participants now.
This study's enrollment of 30 is below the median of 53 across 1,448 interventional studies indexed under Sleep Apnea, Obstructive.
Browse Sleep Apnea, Obstructive studies →ResMed is the lead sponsor of 105 studies on the registry; 13 are open to participants now.
Of its 12 completed or terminated interventional studies of FDA-regulated products, 6 (50%) have results posted.
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Exclusion Criteria:
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) · 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 (nasal) and Comparison Menai Standard mask (nasal) for 7 nights each.
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 (pillows) and Comparison Menai Standard mask (pillows) for 7 nights each.
Device: Menai mask (pillows) · Device: Menai Standard mask (pillows)
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
Usability Performance Evaluation
Evaluation of the usability performance (seal, comfort, etc) of the Menai masks, compared to the Comparison Menai Standard masks.
Time frame: 2 weeks
Humidification Performance Evaluation
Evaluation of the humidification performance of the Menai masks (passive humidification), compared to the Comparison Menai Standard masks (active humidification).
Time frame: 2 weeks
This study is completed, as verified in Feb 2021. You cannot join it, but the record below documents what was studied.
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