N/A
Completed N=37
A Development Study to Evaluate a Nasal Mask for the Treatment of Obstructive Sleep Apnea
Source: ClinicalTrials.gov NCT03124069 ↗Enrolled (actual)
37
Serious AEs
0.0%
Results posted
Jul 2021
Primary outcomePrimary: Number of Participants Reporting Comfort Compared to Their Usual Mask. — 17; 4; 9; 6 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 Number of Participants Reporting Comfort Compared to Their Usual Mask. |
17; 4; 9; 6; 1 | — |
| PRIMARY Number of Participants PAP Device Performance Reporting |
9; 13; 2; 13 | — |
| PRIMARY Number of Participants Subjective Performance Rating of the Nasal Mask |
23; 6; 4; 4; 0 | — |
| PRIMARY Number of Participants Subjective Reporting of Nasal Mask Usability |
23; 9; 5; 0; 0 | — |
| PRIMARY Number of Participants Subjective Recording of Ease of Nasal Mask Use. |
23; 9; 5; 0; 0 | — |
| SECONDARY Number of Participants Leak Compared to Usual Mask |
13; 9; 13; 2 | — |
| SECONDARY Number of Participants With Correct Nasal Mask Size Determination |
22; 6; 9 | — |
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 nasal or nasal pillows mask users (preferable 70%:30% split)
- 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 (NCT03124069). 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.