N/A
Completed N=39
The Evaluation of the Toffee Mask for the Treatment of Obstructive Sleep Apnea
Source: ClinicalTrials.gov NCT03726346 ↗Enrolled (actual)
39
Serious AEs
0.0%
Results posted
Jun 2022
Primary outcomePrimary: Toffee Mask Acceptability — 27; 12 Participants
Summary
This investigation is a prospective, non-randomized, non-blinded study. This investigation is designed to evaluate the performance, comfort and ease of use of the F&P Toffee mask amongst Obstructive Sleep Apnea (OSA) patients. Up to 45 OSA patients will be recruited from the Pulmonary Disease Specialists Research database.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Toffee Mask Acceptability |
27; 12 | — |
| PRIMARY Toffee Mask Comfort |
15; 17; 3; 4; 0 | — |
| PRIMARY Toffee Mask Treatment Seal Performance-Subjective |
14; 14; 9; 2; 0 | — |
| SECONDARY Toffee Mask Treatment Performance-Objective |
19; 10; 10 | — |
Eligibility Criteria
Inclusion Criteria
- Adult (22+ years of age)
- Able to give informed consent
- Apnea hypopnea Index (AHI) ≥ 5 on diagnostic night
- Either prescribed Automatic positive airway pressure (APAP), Continuous positive airway pressure (CPAP) or Bi-level positive airway pressure (PAP) for OSA
- Fluent in spoken and written English
- Existing OSA mask user
Exclusion Criteria
- Inability to give informed consent
- Participant intolerant to PAP
- Anatomical or physiological conditions making PAP therapy inappropriate
- Current diagnosis of respiratory disease or carbon Dioxide (CO2) retention
- Pregnant or may think they are pregnant.
Data sourced from ClinicalTrials.gov (NCT03726346). 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.