Trials / Completed
CompletedNCT03061071
The POSAtive Study: Study for the Treatment of Positional Obstructive Sleep Apnea
A Prospective, Randomized, Crossover Study of the NightBalance Sleep Position Trainer (SPT) Compared to Automatic Adjusting Positive Airway Pressure (APAP) for the Treatment of Positional Obstructive Sleep Apnea (POSA)
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 117 (actual)
- Sponsor
- NightBalance · Industry
- Sex
- All
- Age
- 20 Years – 80 Years
- Healthy volunteers
- Not accepted
Summary
This study is a prospective, multi-center, randomized crossover of the NightBalance SPT compared to APAP for the treatment of Positional Obstructive Sleep Apnea (POSA).
Detailed description
This study is a prospective, multi-center, randomized crossover of the NightBalance SPT compared to APAP for the treatment of POSA. The Primary Objective of the study is to demonstrate non-inferiority of treatment with the SPT as compared to APAP.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | NightBalance Sleep Position Trainer (SPT) | Subject to sleep with the SPT for a 6 week home use period followed by in-lab PSG. |
| DEVICE | Automated Adjusting Positive Airway Pressure (APAP) | Subject to sleep with the APAP for a 6 week home use period followed by in-lab PSG. |
Timeline
- Start date
- 2017-03-01
- Primary completion
- 2018-07-12
- Completion
- 2018-07-12
- First posted
- 2017-02-23
- Last updated
- 2018-08-21
Locations
11 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT03061071. Inclusion in this directory is not an endorsement.