N/A
Completed N=38
A Development Study to Evaluate a Full-Face Mask for the Treatment of Obstructive Sleep Apnea
Source: ClinicalTrials.gov NCT03272763 ↗Enrolled (actual)
38
Serious AEs
0.0%
Results posted
Jun 2022
Primary outcomePrimary: Trial Mask Comfort — 7; 13; 3; 12 Participants
Summary
This 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 |
7; 13; 3; 12; 3 | — |
| PRIMARY Trial Mask Performance - Objective |
9; 3; 9; 17 | — |
| PRIMARY Trial Mask Performance - Subjective |
9; 8; 10; 10; 1 | — |
| PRIMARY Trial Mask Usability |
17; 25; 1 | — |
| PRIMARY Trial Mask Ease-of-Use |
7; 14; 13; 3; 1 | — |
| SECONDARY Mask Leak Data |
1; 3; 10; 6 | — |
| SECONDARY Seal Size Determination |
36; 2 | — |
| SECONDARY Efficacy Data |
18; 3; 14; 3 | — |
Eligibility Criteria
Inclusion Criteria
- AHI ≥ 5 from the diagnostic night
- Aged 22 and over (FDA defined as default)
- Either prescribed APAP, CPAP or Bi-level PAP for OSA
- Existing Full-Face mask user
- Fluent in spoken and written English
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 CO2 retention
- Pregnant or think they may be pregnant
Data sourced from ClinicalTrials.gov (NCT03272763). 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.