Polysomnography Validation of the Sansa Device
NCT06070389 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 533
Last updated 2024-08-14
Summary
The objective of this study is to evaluate the performance of the Sansa device for the diagnosis of sleep disordered breathing.
Conditions
- Sleep-Disordered Breathing
Interventions
- DEVICE
-
Sansa device
The Sansa device will be used during a single overnight polysomnography study.
Sponsors & Collaborators
-
Huxley Medical, Inc.
lead INDUSTRY
Principal Investigators
-
Cathy Goldstein · University of Michigan
Study Design
- Allocation
- NA
- Purpose
- DIAGNOSTIC
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2023-06-01
- Primary Completion
- 2023-12-13
- Completion
- 2023-12-13
- FDA Device
- Yes
Countries
- United States
Study Locations
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