N/A
Completed N=44
F&P Toffee Full Face Mask Clinical Trial, NZ, 2020
Positive Airway Pressure Therapy · Obstructive Sleep Apnea
Source: ClinicalTrials.gov NCT04615832 ↗
Enrolled (actual)
44
Serious AEs
0.0%
Results posted
Nov 2021
Primary outcomePrimary: Comfort - Subjective — 18; 23; 2; 1 Participants
Summary
This will be a prospective, multi-arm, randomized, and non-blinded clinical trial designed to evaluate the performance, comfort, and usability of the Toffee full face mask amongst participants who have been prescribed PAP therapy by a physician. This clinical trial will take place across three investigation sites with a sample of 45 participants.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Comfort - Subjective |
18; 23; 2; 1 | — |
| PRIMARY Usability |
19; 23; 2; 0 | — |
| PRIMARY Seal Performance |
25; 15; 4; 0 | — |
Eligibility Criteria
Inclusion Criteria
- 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 a full face mask
- Persons who have an IPAP pressure of < 30 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
Exclusion Criteria
- 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 nasal or nasal pillows 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
- Persons who currently have cold or flu like symptoms at the time of recruitment
- Persons who have tested positive for COVID-19 within the previous 28 days prior to enrolment
Data sourced from ClinicalTrials.gov (NCT04615832). 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.