N/A
Completed N=45
The Evaluation of a New Nasal Mask for the Treatment of Obstructive Sleep Apnea
Source: ClinicalTrials.gov NCT04011826 ↗Enrolled (actual)
45
Serious AEs
0.0%
Results posted
Jul 2021
Primary outcomePrimary: Number of Participants Objective Trial Mask Performance — 42 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 Objective Trial Mask Performance |
42 | — |
| SECONDARY Number of Participants Trial Mask Overall Simplicity of Use |
53; 36; 2; 7; 2 | — |
| SECONDARY Number of Participants Subjective Trial Mask Comfort |
39; 37; 11; 11; 2 | — |
| SECONDARY Number of Participants Overall Trial Mask Satisfaction |
24; 20 | — |
Eligibility Criteria
Inclusion Criteria
- Diagnosis of OSA by Physician
- ≥ 22 years of age
- ≥ 66 lbs
- Prescribed PAP or BPAP therapy for OSA
- Existing nasal, sub-nasal and pillows mask users
- Fluent in written and spoken English
Exclusion Criteria
- Inability to give informed consent
- Pregnant or think they may be pregnant
- PAP Intolerant
- Anatomical or Physiological Conditions that make PAP inappropriate
- IPAP pressure of ≤25cmH20.
- PAP/BPAP therapy device without data recording capabilities
- Using a PAP/BPAP therapy device for the delivery any medication with the exception of oxygen
Data sourced from ClinicalTrials.gov (NCT04011826). 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.