Trials / Completed
CompletedNCT03999944
Non-Inferiority Study of the FRESCA Airbox Positive Airway Pressure System
Non-Inferiority Study of the FRESCA Airbox Positive Airway Pressure System Versus the (Predicate) FRESCA Positive Airway Pressure System for the Treatment of Obstructive Sleep Apnea
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 52 (actual)
- Sponsor
- FRESCA Medical · Industry
- Sex
- All
- Age
- 22 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
Prospective, open-label, randomized crossover assignment, multi-center non-inferiority study conducted in the United States
Detailed description
This study is designed to demonstrate that the FRESCA Airbox Positive Airway Pressure System is non-inferior to the existing FRESCA Positive Airway Pressure System. Subjects meeting the inclusion and exclusion criteria will be randomized to one sleep night with the existing FRESCA device programmed to fixed pressure and one sleep night with the investigational FRESCA device programmed to auto-adjusting pressure and exhale pressure relief.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | positive airway pressure system | Positive Airway Pressure System |
Timeline
- Start date
- 2019-10-14
- Primary completion
- 2020-01-07
- Completion
- 2020-01-07
- First posted
- 2019-06-27
- Last updated
- 2021-06-23
- Results posted
- 2021-06-23
Locations
6 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT03999944. Inclusion in this directory is not an endorsement.