Evaluation of a Full Face Mask and Headgear for the Treatment of Obstructive Sleep Apnea

Not Applicable

Completed

• Conditions: Obstructive Sleep Apnea
• Interventions: Device: Investigative Full Face Mask with Headgear

• Registration Number: NCT02297789
• Lead Sponsor: Fisher and Paykel Healthcare

Brief Summary

Currently Fisher \& Paykel Healthcare (FPH) is developing a new full face mask. The objective of this clinical investigation is to evaluate the usability and acceptance of the investigative mask, the effectiveness of the seal and headgear.

The participant will be randomised to use either full face mask prototype 1 or 2 as according to the randomization log for 7 ± 3 days in home. The participant will then crossover to the other full face mask prototype to use in home for 7 ± 3 days. Neither the investigators or the participants will be blinded to the study.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-11
• Study First Submitted: 2014-11-19
• Study First Submitted QC: 2014-11-19
• Study First Posted: 2014-11-21
• Primary Completion: 2014-12
• Study Completion: 2014-12
• Status Verified: 2015-07
• Last Update Submitted: 2015-07-22
• Last Update Posted: 2015-07-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 11

Inclusion Criteria

• AHI ≥ 5 from the diagnostic night
• ≥ 18 years of age
• Either prescribed APAP or CPAP or Bi level for OSA
• Existing full face users

Exclusion Criteria

• Inability to give informed consent
• Participant intolerance to PAP
• Anatomical or physiological conditions making PAP therapy inappropriate
• Current diagnosis of respiratory disease or CO2 retention
• Pregnant or think they may be pregnant

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Headgear 1	Investigative Full Face Mask with Headgear	Full Face Mask with Headgear 1
Headgear 2	Investigative Full Face Mask with Headgear	Full Face Mask with Headgear 2

Primary Outcome Measures

Name	Time	Method
The mask is comfortable and is effective for the participant during in-home use	1 week for each mask prototype in-home	Performance in relations to leak and comfort of each prototype and how it compares to their usual mask, as measured by a custom questionnaire, daily participant feedback log and PAP device data.

Secondary Outcome Measures

Name	Time	Method
Acceptability of the Full Face mask prototypes	1 week for each mask prototype in-home	Preference for one of the Full Face Mask prototypes design through a custom questionnaire and a daily participant feedback log

Trial Locations

Locations (1)

Fisher & Paykel Healthcare Ltd.; 🇳🇿 Auckland, East Tamaki, New Zealand