Comparative Study of the ANNE™ One System to Diagnose Obstructive Sleep Apnea
NCT04643782 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 287
Last updated 2023-02-14
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
Conditions
- Obstructive Sleep Apnea of Adult
Interventions
- DEVICE
-
ANNE Sleep
ANNE sleep system
Sponsors & Collaborators
-
Sibel Health Inc.
collaborator INDUSTRY - lead OTHER
Study Design
- Allocation
- NA
- Purpose
- DIAGNOSTIC
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 22 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2021-05-11
- Primary Completion
- 2021-11-17
- Completion
- 2021-12-27
- FDA Device
- Yes
Countries
- United States
Study Locations
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