Non-Inferiority Study of the FRESCA Airbox Positive Airway Pressure System
NCT03999944 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 52
Last updated 2021-06-23
Summary
Prospective, open-label, randomized crossover assignment, multi-center non-inferiority study conducted in the United States
Conditions
Interventions
- DEVICE
-
positive airway pressure system
Positive Airway Pressure System
Sponsors & Collaborators
-
FRESCA Medical
lead INDUSTRY
Principal Investigators
-
Mark Goetting, MD · Bronson Sleep Health
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- SINGLE
- Model
- CROSSOVER
Eligibility
- Min Age
- 22 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2019-10-14
- Primary Completion
- 2020-01-07
- Completion
- 2020-01-07
- FDA Device
- Yes
Countries
- United States
Study Locations
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