Status:
COMPLETED
Polysomnography Validation of the Sansa Device
Lead Sponsor:
Huxley Medical, Inc.
Conditions:
Sleep-Disordered Breathing
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The objective of this study is to evaluate the performance of the Sansa device for the diagnosis of sleep disordered breathing.
Eligibility Criteria
Inclusion
- 18 years of age or older
- able to read, understand, and sign informed consent documentation
- willing to sleep with the Sansa device and PSG simultaneously in the sleep clinic
- suspected or known to have sleep disordered breathing
Exclusion
- exhibit deformities of the chest that would interfere with sensor placement
- have broken or injured skin that would interfere with sensor placement
- known to experience adverse reactions to medical-grade adhesive
- diagnosed with hypoventilation
- diagnosed with severe chronic obstructive pulmonary disease
- exhibit symptoms of significant non-respiratory sleep disorders
- diagnosed with a neuromuscular disorder leading to muscle weakness
- chronically use supplemental oxygen at night or during the day
- pregnant
- scheduled to undergo titration of a hypoglossal nerve stimulation device
- undergo permanent pacing with an implanted pacemaker
- diagnosed with congestive heart failure with an ejection fraction less than 45%
Key Trial Info
Start Date :
June 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 13 2023
Estimated Enrollment :
533 Patients enrolled
Trial Details
Trial ID
NCT06070389
Start Date
June 1 2023
End Date
December 13 2023
Last Update
August 14 2024
Active Locations (2)
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1
Pulmonary & Sleep Specialists
Decatur, Georgia, United States, 30033
2
University of Michigan
Ann Arbor, Michigan, United States, 48109