N/A
Completed N=38
The Evaluation of a Full Face Mask Seal for the Treatment of Obstructive Sleep Apnea
Source: ClinicalTrials.gov NCT03230877 ↗Enrolled (actual)
38
Serious AEs
0.0%
Results posted
Sep 2022
Primary outcomePrimary: Trial Mask Seal Comfort — 16; 13; 16; 19 Participants
Summary
The investigation is a prospective, randomized, single blinded, crossover study. The investigation is designed to evaluate the performance, comfort and ease of use of the F&P Trial Full Face Mask Seal amongst Obstructive Sleep Apnea (OSA) participants. A total number of 40-45 OSA participants will be recruited for the trial by the investigation site
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Trial Mask Seal Comfort |
16; 13; 16; 19; 2; 1 | — |
| PRIMARY Trial Mask Seal Acceptability |
19; 15; 3; 1 | — |
| SECONDARY Trial Mask Seal Treatment Performance - Objective |
10; 6; 3; 4; 7; 11 | — |
| SECONDARY Trial Mask Seal Usability |
28; 26; 8; 7; 0; 2 | — |
| SECONDARY Trial Mask Seal Treatment Performance- Subjective |
19; 17; 11; 12; 3; 4 | — |
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 F&P full face 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 (NCT03230877). 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.