Status:
COMPLETED
A Development Study to Evaluate a Full-Face Mask for the Treatment of Obstructive Sleep Apnea
Lead Sponsor:
Fisher and Paykel Healthcare
Conditions:
Obstructive Sleep Apnea
Eligibility:
All Genders
22+ years
Phase:
NA
Brief Summary
This 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
This investigation is a prospective, non-randomized, non-blinded study. Up to 45 OSA participants who currently use a full-face mask will be recruited. This study will involve a baseline (Visit One) ...
Eligibility Criteria
Inclusion
- AHI ≥ 5 from the diagnostic night
- Aged 22 and over (FDA defined as default)
- Either prescribed APAP, CPAP or Bi-level PAP for OSA
- Existing Full-Face mask user
- Fluent in spoken and written English
Exclusion
- Inability to give informed consent
- Participant intolerant 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 :
October 9 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 9 2018
Estimated Enrollment :
38 Patients enrolled
Trial Details
Trial ID
NCT03272763
Start Date
October 9 2017
End Date
October 9 2018
Last Update
June 21 2022
Active Locations (1)
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1
California Sleep Solutions
Roseville, California, United States, 95661