Evaluation of the Toffee Nasal and Toffee Nasal Pillows Mask in Home, USA, 2022
Completed · Not applicable
Conditions studied: Obstructive Sleep Apnea
In brief
This clinical investigation is designed to assess the F\&P Toffee Nasal and Toffee Nasal Pillows masks in home for use during PAP therapy delivery. The objectives of the investigation are to assess therapeutic efficacy, safety and comfort.
Key facts
- Study ID
- NCT05496062
- Run by
- Fisher and Paykel Healthcare
- People needed
- 91
- Starts
- 2022-09-12
- Expected to finish
- 2024-04-30
- Last updated by the study team
- 2024-05-24
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 lbs (30 kgs)
- Persons who have been prescribed PAP (APAP, BPAP or CPAP) therapy by a physician
- Persons who are compliant with PAP therapy for ≥ 4 hours per night for 70% of nights for at least two weeks prior to enrolment in the trial
- Persons who are currently using either a nasal, sub-nasal or nasal pillows mask
- Persons who have an IPAP pressure of < 20 cmH2O
- Persons who currently use a PAP therapy device with data recording capabilities
- 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 are required to use PAP therapy for more than 12 hours per day or for extensive periods other than sleep or naps
- Persons using full face masks
- Persons who possess, or suffer from, anatomical or physiological conditions which make PAP therapy inappropriate
- Persons who are pregnant or think they may be pregnant
- Persons who use a PAP therapy machine for the delivery of medicines, except supplemental O2
Where it is running
- Clinical Site Partners, LLC - DBA CSP Miami — Miami, Florida, United States
- Clayton Sleep Institute — St Louis, Missouri, United States
Full record on ClinicalTrials.gov
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