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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Menai mask (full face) | Device | Prototype mask system (full face variant) with novel vent and humidification system |
|
| Measure | Description | Time Frame |
|---|---|---|
| Usability Performance Evaluation | Evaluation of the usability performance (seal, comfort, etc) of the Menai masks, compared to the Comparison Menai Standard masks. | 2 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Humidification Performance Evaluation | Evaluation of the humidification performance of the Menai masks (passive humidification), compared to the Comparison Menai Standard masks (active humidification). | 2 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Klaus Schindhelm, BE PhD | Graduate School of Biomedical Engineering, University of New South Wales, Sydney Australia and Applied Research, ResMed Ltd Sydney Australia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ResMed Sleep Research Centre | Sydney | New South Wales | 2153 | Australia |
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| ID | Term |
|---|---|
| D020181 | Sleep Apnea, Obstructive |
| D001049 | Apnea |
| ID | Term |
|---|---|
| D012891 | Sleep Apnea Syndromes |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D020919 | Sleep Disorders, Intrinsic |
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| 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 |
|
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |