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

July 22, 2015 updated by: Fisher and Paykel Healthcare

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

11

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • New Zealand
    • East Tamaki
      • Auckland, East Tamaki, New Zealand, 1010
        • Fisher & Paykel Healthcare Ltd.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Headgear 1
Full Face Mask with Headgear 1
Device: Investigative Full Face Mask with Headgear
Experimental: Headgear 2
Full Face Mask with Headgear 2
Device: Investigative Full Face Mask with Headgear

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1 week for each mask prototype in-home

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
1 week for each mask prototype in-home

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fisher and Paykel Healthcare

Investigators

  • Principal Investigator: Bhavi Ogra, BSc, Fisher & Paykel Healthcare

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2014

Primary Completion (Actual)

December 1, 2014

Study Completion (Actual)

December 1, 2014

Study Registration Dates

First Submitted

November 19, 2014

First Submitted That Met QC Criteria

November 19, 2014

First Posted (Estimate)

November 21, 2014

Study Record Updates

Last Update Posted (Estimate)

July 24, 2015

Last Update Submitted That Met QC Criteria

July 22, 2015

Last Verified

July 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CIA-152

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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