Trials / Completed
CompletedNCT03375905
Effectiveness and Safety of cNEP in Ethnic Japanese With Obstructive Sleep Apnea
Pilot Study to Evaluate the Effectiveness and Safety of the aerSleep™ System in an Ethnic Japanese Population Diagnosed With Obstructive Sleep Apnea (OSA)
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 8 (actual)
- Sponsor
- Sommetrics, Inc. · Industry
- Sex
- All
- Age
- 18 Years – 70 Years
- Healthy volunteers
- Not accepted
Summary
The aim of this study is to evaluate the effectiveness and safety of cNEP (continuous negative external pressure) for the treatment of obstructive sleep apnea during two weeks of home use in subjects of Japanese ethnicity.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | cNEP | subjects with OSA will be treated with the cNEP device with the goal of reducing the number of apneas and hypopneas |
Timeline
- Start date
- 2017-12-07
- Primary completion
- 2019-03-28
- Completion
- 2019-04-26
- First posted
- 2017-12-18
- Last updated
- 2019-09-19
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT03375905. Inclusion in this directory is not an endorsement.