N/A
N=70
Field Usability Study of Eclipse Mask
Obstructive Sleep Apnea
Bottom Line
View on ClinicalTrials.gov: NCT05559047 ↗Enrolled (actual)
70
Serious AEs
0.0%
Results posted
Nov 2025
Primary outcome: Primary: Number of Participants Who Asked for Additional Information — 6 Participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Eclipse mask (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Bleep, LLC
- Primary completion
- Jan 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Who Asked for Additional Information |
6 | — |
| PRIMARY Mask Likeability |
4.1 | — |
| PRIMARY Number of Participants Who Experienced Technical Issues |
7 | — |
Summary
The study is designed to assess the usability of a novel CPAP human interface compared to a traditional nasal mask. Human subjects will interact with two different CPAP interfaces including a traditional CPAP mask and the 2nd generation DreamPort-Eclipse. Subjects will be requested to put on each of the different CPAP interface options a total of three times for a total of 6 trials. The order of device will be randomized.
Eligibility Criteria
Inclusion Criteria
•Male or female ≥18 years old who are impacted by obstructive sleep apnea and currently are familiar with a CPAP device.
Exclusion Criteria
- Diagnosis of any medical or behavioral conditions that would compromise subject safety.
- Under the age of 18: target for this current version of the platform is the adult population.
Data sourced from ClinicalTrials.gov (NCT05559047). 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.