Trials / Completed
CompletedNCT04643782
Comparative Study of the ANNE™ One System to Diagnose Obstructive Sleep Apnea
A Single Arm, Open-Label, Multi-Center, and Comparative Study of the Anne Sleep System Versus Polysomnography to Diagnose Obstructive Sleep Apnea: ANNE Program for the Non-Invasive Evaluation of Apnea in Sleep (APNEAs)
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 287 (actual)
- Sponsor
- Northwestern University · Academic / Other
- Sex
- All
- Age
- 22 Years
- Healthy volunteers
- Accepted
Summary
The main objective of this study is to evaluate the accuracy of the ANNE Sleep system for the diagnosis of obstructive sleep apnea (OSA) in adults
Detailed description
The main object of this study is to evaluate the accuracy of the ANNE Sleep system for the diagnosis of obstructive sleep apnea (OSA) in adults. Our primary hypothesis is that the ANNE Sleep system is non-inferior compared to polysomnography (PSG) for the diagnosis of obstructive sleep apnea
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | ANNE Sleep | ANNE sleep system |
Timeline
- Start date
- 2021-05-11
- Primary completion
- 2021-11-17
- Completion
- 2021-12-27
- First posted
- 2020-11-25
- Last updated
- 2023-02-14
- Results posted
- 2023-02-14
Locations
4 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT04643782. Inclusion in this directory is not an endorsement.