N/A
Completed N=40
Evaluation of the F&P Toffee Nasal Pillows Mask, US, 2022
Source: ClinicalTrials.gov NCT05573763 ↗Enrolled (actual)
40
Serious AEs
0.0%
Results posted
Sep 2025
Primary outcomePrimary: Therapeutic Efficacy — 2 events per hour
Summary
The purpose of this clinical investigation is to evaluate the performance and safety of the F&P Toffee nasal pillows mask in a home environment.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Therapeutic Efficacy |
2 | — |
| PRIMARY Epworth Sleepiness Scale |
10 | — |
Eligibility Criteria
Inclusion Criteria
- 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 pillows mask users with at ≥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 Criteria
- 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 >25 cmH2O if on BPAP
- Persons who use a PAP therapy device for the delivery of medicines, except supplemental O2
- 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
Data sourced from ClinicalTrials.gov (NCT05573763). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.