N/A
Completed N=44
Evaluation of a Full-Face Mask for the Treatment of Obstructive Sleep Apnea (OSA)
Source: ClinicalTrials.gov NCT03329352 ↗Enrolled (actual)
44
Serious AEs
4.8%
Results posted
Sep 2021
Primary outcomePrimary: Trial Mask Comfort — 20; 16; 4; 1 Participants
Summary
The investigation is designed to evaluate the comfort, ease of use and performance of a trial nasal mask for the treatment of Obstructive Sleep Apnea (OSA) in the home environment.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Trial Mask Comfort |
20; 16; 4; 1; 0; 1 | — |
| PRIMARY Participant Count of Acceptable Trial Mask Performance - Objective |
34; 0; 8 | — |
| PRIMARY Trial Mask Seal Performance - Subjective |
17; 14; 4; 4; 2; 1 | — |
| PRIMARY Trial Mask Ease of Cleaning |
25; 15; 2; 0; 0 | — |
| PRIMARY Trial Mask Ease-of-use |
27; 14; 1; 0; 0 | — |
| SECONDARY Participant Count of Acceptable Mask Leak |
30; 4; 8 | — |
| SECONDARY Participant Count of Seal Size Determination |
28; 16 | — |
Eligibility Criteria
Inclusion Criteria
- AHI ≥ 5 from diagnostic PSG night
- Aged 22 and over (FDA defined as adult)
- Either prescribed APAP, CPAP or Bi-Level PAP for OSA
- Existing full-face mask users
- Fluent in spoken and written English
Exclusion Criteria
- Inability to give informed consent
- Patient intolerant to CPAP therapy
- Anatomical or physiological conditions making PAP therapy inappropriate
- Current diagnosis of respiratory disease or CO2 retention
- Pregnant or think they may be pregnant.
Data sourced from ClinicalTrials.gov (NCT03329352). 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.