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

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.

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Key information

Conditions

Obstructive Sleep Apnea Apnea Dyssomnias Nervous System Diseases Respiration Disorders Respiratory Tract Diseases Sleep Apnea Syndromes Sleep Apnea, Obstructive Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Fisher & Paykel Healthcare Ltd.

Auckland, East Tamaki, 1010, New Zealand

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Investigative Full Face Mask with Headgear

Device

Primary outcomes

The mask is comfortable and is effective for the participant during in-home use

Time frame: 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 outcomes

Acceptability of the Full Face mask prototypes

Time frame: 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

Sponsors and collaborators

Lead sponsor

Fisher and Paykel Healthcare

Industry

Registry information

Important dates

Study start: 2014
Primary completion: 2014
Study completion: 2014
First posted: Nov 21, 2014
Registry last updated: Jul 24, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed