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Usability Evaluation of Menai CPAP Masks

NCT02364375 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2021-02-04

No results posted yet for this study

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.

Conditions

Interventions

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

Sponsors & Collaborators

  • ResMed

    lead INDUSTRY

Principal Investigators

  • Klaus Schindhelm, BE PhD · Graduate School of Biomedical Engineering, University of New South Wales, Sydney Australia and Applied Research, ResMed Ltd Sydney Australia

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-05-31
Primary Completion
2015-07-31
Completion
2015-07-31

Countries

  • Australia

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02364375 on ClinicalTrials.gov