Back to resultsInvestigative Headgear With CPAP Mask
Primary Purpose
Obstructive Sleep Apnea
Status
Completed
Phase
Not Applicable
Locations
New Zealand
Study Type
Interventional
Intervention
Headgear
Sponsored by
About this trial
This is an interventional other trial for Obstructive Sleep Apnea
Eligibility Criteria
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
Sites / Locations
- Fisher & Paykel Healthcare
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Headgear
Arm Description
Investigative Headgear with CPAP Mask.
Outcomes
Primary Outcome Measures
Participants perception of the headgear on mask performance
Assess if the headgear with mask changes the perception of the performance of the mask.
Secondary Outcome Measures
Number of participants that choose this Headgear over their usual.
Assess the acceptability of the headgear with mask.
Full Information
NCT ID
NCT02323035
First Posted
December 15, 2014
Last Updated
April 16, 2019
Sponsor
Fisher and Paykel Healthcare
1. Study Identification
Unique Protocol Identification Number
NCT02323035
Brief Title
Investigative Headgear With CPAP Mask
Official Title
Investigative Headgear With CPAP Mask
Study Type
Interventional
2. Study Status
Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
December 2014 (undefined)
Primary Completion Date
November 2016 (Actual)
Study Completion Date
November 2016 (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
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.
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
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
23 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Headgear
Arm Type
Experimental
Arm Description
Investigative Headgear with CPAP Mask.
Intervention Type
Device
Intervention Name(s)
Headgear
Intervention Description
Investigative Headgear with CPAP Mask.
Primary Outcome Measure Information:
Title
Participants perception of the headgear on mask performance
Description
Assess if the headgear with mask changes the perception of the performance of the mask.
Time Frame
2-4 weeks
Secondary Outcome Measure Information:
Title
Number of participants that choose this Headgear over their usual.
Description
Assess the acceptability of the headgear with mask.
Time Frame
2-4 weeks
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
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bhavi Ogra, BSc
Organizational Affiliation
Clinical Research Scientist
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fisher & Paykel Healthcare
City
Auckland
ZIP/Postal Code
2013
Country
New Zealand
12. IPD Sharing Statement
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Investigative Headgear With CPAP Mask
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