Status:
COMPLETED
Evaluation of a Full Face Mask and Headgear for the Treatment of Obstructive Sleep Apnea
Lead Sponsor:
Fisher and Paykel Healthcare
Conditions:
Obstructive Sleep Apnea
Eligibility:
All Genders
18+ years
Phase:
NA
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2014
Estimated Enrollment :
11 Patients enrolled
Trial Details
Trial ID
NCT02297789
Start Date
November 1 2014
End Date
December 1 2014
Last Update
July 24 2015
Active Locations (1)
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1
Fisher & Paykel Healthcare Ltd.
Auckland, East Tamaki, New Zealand, 1010