NCT02364375

Usability Evaluation of Menai CPAP Masks

Menai Mask Systems - Clinical Study 1

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: ResMed · Industry
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

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.

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

Interventions

Type	Name	Description
DEVICE	Menai mask (full face)	Prototype mask system (full face variant) with novel vent and humidification system
DEVICE	Menai Standard mask (full face)	Prototype mask system (full face variant) with conventional vent and humidification system
DEVICE	Menai mask (nasal)	Prototype mask system (nasal variant) with novel vent and humidification system
DEVICE	Menai Standard mask (nasal)	Prototype mask system (nasal variant) with conventional vent and humidification system
DEVICE	Menai mask (pillows)	Prototype mask system (pillows variant) with conventional vent and humidification system
DEVICE	Menai Standard mask (pillows)	Prototype mask system (pillows variant) with conventional vent and humidification system

Timeline

• Start date: 2015-05-01
• Primary completion: 2015-07-01
• Completion: 2015-07-01
• First posted: 2015-02-18
• Last updated: 2021-02-04

Locations

1 site across 1 country: Australia