Status:
COMPLETED
Evaluation of a Full-Face Mask for the Treatment of Obstructive Sleep Apnea (OSA)
Lead Sponsor:
Fisher and Paykel Healthcare
Conditions:
Obstructive Sleep Apnea
Eligibility:
All Genders
22+ years
Phase:
NA
Brief Summary
The investigation is designed to evaluate the comfort, ease of use and performance of a trial nasal mask for the treatment of Obstructive Sleep Apnea (OSA) in the home environment.
Detailed Description
The investigation is a prospective, non-randomized, non-blinded study. Up to 45 OSA participants who currently use a full-face mask will be recruited. The study will involve a baseline (Visit 1) data...
Eligibility Criteria
Inclusion
- AHI ≥ 5 from diagnostic PSG night
- Aged 22 and over (FDA defined as adult)
- Either prescribed APAP, CPAP or Bi-Level PAP for OSA
- Existing full-face mask users
- Fluent in spoken and written English
Exclusion
- Inability to give informed consent
- Patient intolerant to CPAP therapy
- 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 3 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 31 2018
Estimated Enrollment :
44 Patients enrolled
Trial Details
Trial ID
NCT03329352
Start Date
November 3 2017
End Date
July 31 2018
Last Update
November 10 2021
Active Locations (1)
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1
North Texas Lung and Sleep Clinic
Fort Worth, Texas, United States, 76109