N/A
Completed N=57
The Evaluation of a Mask for the Treatment of Obstructive Sleep Apnea
Source: ClinicalTrials.gov NCT03142438 ↗Enrolled (actual)
57
Serious AEs
0.0%
Results posted
Jul 2021
Primary outcomePrimary: Number of Participants Subjective Usability Reporting — 14; 41; 2 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 with the F&P trial full face and nasal mask amongst Obstructive Sleep Apnea (OSA) patients. Up to 70 OSA patients will be recruited from the North Texas Lung and Sleep Clinic (NTLSC) database
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Subjective Usability Reporting |
14; 41; 2 | — |
| PRIMARY Number or Participants Comparative Subjective Reported Comfort |
27; 24; 6 | — |
| SECONDARY Objective Performance Reporting |
17; 3; 8; 29 | — |
| SECONDARY Number of Participants Reported Mask Acceptability |
27; 18; 12 | — |
| SECONDARY Number of Participants Subjective Comfort Reporting |
35; 16; 4; 2; 0 | — |
| SECONDARY Number or Participants Subjective Reporting of Seal Performance |
28; 22; 6; 1; 0 | — |
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 oronasal and nasal 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 (NCT03142438). 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.