Trials / Completed
CompletedNCT05818540
Sleep Apnea Study in Adults Using DreamPort-Eclipse and a Traditional Nasal Mask
Randomized Controlled Trial to Compare Effectiveness of DreamPort-Eclipse to a Traditional Nasal Mask
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 173 (actual)
- Sponsor
- Bleep, LLC · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Accepted
Summary
The Randomized Controlled Trial of Bleep DreamPort-Eclipse Study is a two-arm, randomized, prospective, non-blinded study to assess the effectiveness of the novel CPAP human interface design to improve leak, AHI, and pressure compared to a traditional nasal mask.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Eclipse novel CPAP mask | Participants will wear the mask for 6 hours a night for 60 days. |
| DEVICE | ResMed P-10 mask | Participants will wear the mask for 6 hours a night for 60 days. |
Timeline
- Start date
- 2023-04-17
- Primary completion
- 2023-12-29
- Completion
- 2023-12-29
- First posted
- 2023-04-19
- Last updated
- 2025-11-10
- Results posted
- 2025-11-10
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT05818540. Inclusion in this directory is not an endorsement.