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

Primary Purpose

Obstructive Sleep Apnea

Status
Completed
Phase
Not Applicable
Locations
New Zealand
Study Type
Interventional
Intervention
Investigative Full Face Mask with Headgear
Sponsored by
Fisher and Paykel Healthcare
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obstructive Sleep Apnea

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Fisher & Paykel Healthcare Ltd.

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Headgear 1

Headgear 2

Arm Description

Full Face Mask with Headgear 1

Full Face Mask with Headgear 2

Outcomes

Primary Outcome Measures

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

Acceptability of the Full Face mask prototypes
Preference for one of the Full Face Mask prototypes design through a custom questionnaire and a daily participant feedback log

Full Information

First Posted
November 19, 2014
Last Updated
July 22, 2015
Sponsor
Fisher and Paykel Healthcare
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1. Study Identification

Unique Protocol Identification Number
NCT02297789
Brief Title
Evaluation of a Full Face Mask and Headgear for the Treatment of Obstructive Sleep Apnea
Official Title
Evaluation of a Full Face Mask and Headgear for the Treatment of Obstructive Sleep Apnea
Study Type
Interventional

2. Study Status

Record Verification Date
July 2015
Overall Recruitment Status
Completed
Study Start Date
November 2014 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
December 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fisher and Paykel Healthcare

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstructive Sleep Apnea

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
11 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Headgear 1
Arm Type
Experimental
Arm Description
Full Face Mask with Headgear 1
Arm Title
Headgear 2
Arm Type
Experimental
Arm Description
Full Face Mask with Headgear 2
Intervention Type
Device
Intervention Name(s)
Investigative Full Face Mask with Headgear
Primary Outcome Measure Information:
Title
The mask is comfortable and is effective for the participant during in-home use
Description
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.
Time Frame
1 week for each mask prototype in-home
Secondary Outcome Measure Information:
Title
Acceptability of the Full Face mask prototypes
Description
Preference for one of the Full Face Mask prototypes design through a custom questionnaire and a daily participant feedback log
Time Frame
1 week for each mask prototype in-home

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bhavi Ogra, BSc
Organizational Affiliation
Fisher & Paykel Healthcare
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fisher & Paykel Healthcare Ltd.
City
Auckland
State/Province
East Tamaki
ZIP/Postal Code
1010
Country
New Zealand

12. IPD Sharing Statement

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

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