Investigative Headgear With CPAP Mask

Not Applicable

Completed

• Conditions: Obstructive Sleep Apnea

• Registration Number: NCT02323035
• Lead Sponsor: Fisher and Paykel Healthcare

Brief Summary

This investigation is designed to evaluate the at-home usability, performance, user acceptance and reliability of the Headgear with a CPAP Mask for a duration of 2-4 weeks.

Detailed Description

Up to 300 participants will be recruited for the trial, consisting of male and female participants diagnosed with OSA and receiving CPAP or Bi-level PAP for the treatment of their OSA. These include current CPAP mask users.

Study Timeline

• Study Start: 2014-12
• Study First Submitted: 2014-12-15
• Study First Submitted QC: 2014-12-17
• Study First Posted: 2014-12-23
• Primary Completion: 2016-11
• Study Completion: 2016-11
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-16
• Last Update Posted: 2019-04-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 23

Inclusion Criteria

• AHI≥5 from the diagnostic night
• ≥18 years of age
• Prescribed CPAP or Bilevel therapy for OSA
• Existing CPAP mask users

Exclusion Criteria

• Inability to give informed consent
• Patient intolerant to PAP
• Anatomical or physiological conditions making PAP therapy inappropriate
• History of respiratory disease or CO2 retention.
• Pregnant or think they may be pregnant
• Investigated by Land Transport Safety Authority

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Participants perception of the headgear on mask performance	2-4 weeks	Assess if the headgear with mask changes the perception of the performance of the mask.

Secondary Outcome Measures

Name	Time	Method
Number of participants that choose this Headgear over their usual.	2-4 weeks	Assess the acceptability of the headgear with mask.

Trial Locations

Locations (1)

Fisher & Paykel Healthcare; 🇳🇿 Auckland, New Zealand