Usability Evaluation of Menai CPAP Masks

Obstructive Sleep Apnea Clinical Trial

Official title:

Menai Mask Systems - Clinical Study 1

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02364375
• Other study ID #: MA220115
• Status: Completed
• Phase: N/A
• Start date: May 2015
• Est. completion date: July 2015

Study information

• Verified date: February 2021
• Source: ResMed
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: July 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

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

Related Conditions & MeSH terms

• Obstructive Sleep Apnea
• Sleep Apnea, Obstructive

Intervention

Device:
• Menai mask (full face)
Prototype mask system (full face variant) with novel vent and humidification system
• Menai Standard mask (full face)
Prototype mask system (full face variant) with conventional vent and humidification system
• Menai mask (nasal)
Prototype mask system (nasal variant) with novel vent and humidification system
• Menai Standard mask (nasal)
Prototype mask system (nasal variant) with conventional vent and humidification system
• Menai mask (pillows)
Prototype mask system (pillows variant) with conventional vent and humidification system
• Menai Standard mask (pillows)
Prototype mask system (pillows variant) with conventional vent and humidification system

Locations

Country	Name	City	State
Australia	ResMed Sleep Research Centre	Sydney	New South Wales

Sponsors (1)

Lead Sponsor	Collaborator
ResMed

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Usability Performance Evaluation	Evaluation of the usability performance (seal, comfort, etc) of the Menai masks, compared to the Comparison Menai Standard masks.	2 weeks
Secondary	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