Evaluation of the F&P Caramel Nasal Mask, US, 2023
Completed · Not applicable
Conditions studied: Obstructive Sleep Apnea
In brief
The purpose of this clinical investigation is to evaluate the performance and safety of the F\&P Caramel nasal mask in a home environment.
Key facts
- Study ID
- NCT06060717
- Run by
- Fisher and Paykel Healthcare
- People needed
- 45
- Starts
- 2023-11-27
- Expected to finish
- 2024-06-11
- Last updated by the study team
- 2025-09-23
Who can join
Age: 22 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Clayton Sleep Institute — St Louis, Missouri, United States
Full record on ClinicalTrials.gov
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