Evaluation of Continuous Positive Airway Pressure Mask Systems: Comparison of Cushions, Frames, Headgear, Components and Accessories

Not Applicable

Recruiting

• Conditions: Obstructive Sleep Apnea (OSA); Respiratory - Sleep apnoea

• Registration Number: ACTRN12614000998640
• Lead Sponsor: ResMed Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-09-16
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

Patients willing to give written informed consent
Patients who are able to comprehend written and spoken English
Patients who have been diagnosed with OSA
Patients who are established CPAP therapy users
Patients who are at least 18 years of age
Patients who are using an appropriate current mask system and size for the particular study

Exclusion Criteria

Patients who are not able to provide written informed consent
Patients who are unable to comprehend written and spoken English
Patients who are not using an appropriate current mask system and size for the particular study
Patients who are pregnant
Patients with a pre existing lung disease/ condition that would predispose them to pneumothorax (for example: COPD, lung cancer; fibrosis of the lungs; recent (< 2years) case of pneumonia or lung infection; lung injury.
Patients who are unsuitable for inclusion in the opinion of the investigator

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Subjective mask comfort as assessed by patient questionnaire (ie. 11-point Likert scale designed for this protocol)[After maximum of 7 nights on CPAP mask];Subjective mask seal as assessed by patient questionnaire (ie. 11-point Likert scale designed for this protocol)[After a maximum of 7 nights on CPAP mask];Subjective mask stability as assessed by patient questionnaire (ie. 11-point Likert scale designed for this protocol)[After a maximum of 7 nights on CPAP mask]

Secondary Outcome Measures

Name	Time	Method
Objective mask efficacy as assessed by CPAP device data[After a maximum of 7 nights on CPAP mask];Objective mask leak as assessed by CPAP device data[After a maximum of 7 nights on CPAP mask];Objective mask usage assessed by CPAP device data[After a maximum of 7 nights on CPAP mask];Objective mask pressure as assessed by CPAP device data[After a maximum of 7 nights on CPAP mask];Primary Outcome: Subjective general usability as assessed by patient questionnaire (ie. 11-point Likert scale designed for this protocol)[After a maximum of 7 nights of CPAP mask]