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

Not Applicable

Recruiting

• Conditions: Intervention intended for treatment of Obstructive Sleep Apnea (OSA); Respiratory - Sleep apnoea

• Registration Number: ACTRN12614000999639
• 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

Participants have been trained in The Rights and Responsibilities of Trial Participants
Participants willing to give written informed consent
Participants who are able to comprehend written and spoken English
Participants that are willing and able to complete the specified follow up evaluations
Participants who are at least 18 years of age

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 unable to commit to the duration of the trial
Participant is a design engineer directly involved with designing the prototype being trialled
Participants 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.
Participants 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 study)[After maximum of 7 nights on CPAP mask<br>];Subjective mask seal as assessed by patient questionnaire (ie. 11-point Likert scale designed for this study)[After maximum of 7 nights on CPAP mask];Subjective mask stability as assessed by patient questionnaire (ie. 11-point Likert scale designed for this study)[After 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<br>];Objective mask leak as assessed by CPAP device data[After a maximum of 7 nights on CPAP mask];Objective mask usage as 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 study)[After a maximum of 7 nights on CPAP mask]