Status:
COMPLETED
Evaluation of the F&P Caramel Nasal Mask, US, 2023
Lead Sponsor:
Fisher and Paykel Healthcare
Conditions:
Obstructive Sleep Apnea
Eligibility:
All Genders
22+ years
Phase:
NA
Brief Summary
The purpose of this clinical investigation is to evaluate the performance and safety of the F\&P Caramel nasal mask in a home environment.
Eligibility Criteria
Inclusion
- Persons who are ≥22 years of age
- Persons who weigh ≥66 pounds
- Persons who have been prescribed PAP therapy by a physician
- Persons who are existing nasal mask or sub-nasal mask users with ≥3 months of use prior to enrolment in the clinical trial
- Persons who are compliant with PAP therapy for ≥4 hours per night for ≥70% of nights for a 14-day period within 30 days prior to enrolment in the clinical trial
- Persons who are fluent in spoken and written English
- Persons who possess the capacity to provide informed consent
Exclusion
- Persons who are intolerant to PAP therapy
- Persons who possess, or suffer from, anatomical or physiological conditions which make PAP therapy inappropriate
- Persons who are required to use PAP therapy for \>12 hours per day or for extensive periods, not including sleep or naps
- Persons who are trying to get pregnant, are pregnant, or think they may be pregnant
- Persons who have an IPAP pressure of \>30 cmH2O if on BPAP
- Persons who use a PAP therapy device for the delivery of medicines, except supplemental oxygen
- Persons who use a PAP therapy device that does not possess data recording capabilities to capture AHI and a numerical indicator of leak that is accessible to the investigation site
Key Trial Info
Start Date :
November 27 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 11 2024
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT06060717
Start Date
November 27 2023
End Date
June 11 2024
Last Update
September 23 2025
Active Locations (1)
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1
Clayton Sleep Institute
St Louis, Missouri, United States, 63123