ANNE Diagnostic Agreement With Home Sleep Testing
NCT05421754 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 38
Last updated 2023-05-26
Summary
The main objective of this study is to provide an adequately powered study that would provide evidence on the non-inferiority of ANNE to a Home Sleep Test (HST).
Conditions
- Obstructive Sleep Apnea of Adult
Interventions
- DEVICE
-
ANNE Sleep
ANNE Sleep system for 1 night with HST followed by 3 nights of ANNE Sleep system alone.
Sponsors & Collaborators
-
Sibel Health Inc.
collaborator INDUSTRY - lead OTHER
Study Design
- Allocation
- NA
- Purpose
- OTHER
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 22 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-01-06
- Primary Completion
- 2022-04-30
- Completion
- 2023-02-28
- FDA Device
- Yes
Countries
- United States
Study Locations
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