Polysomnography Validation of the Sansa Device
Not Applicable
Completed
- Conditions
- Sleep-Disordered Breathing
- Registration Number
- NCT06070389
- Lead Sponsor
- Huxley Medical, Inc.
- Brief Summary
The objective of this study is to evaluate the performance of the Sansa device for the diagnosis of sleep disordered breathing.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 533
Inclusion Criteria
- 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 Criteria
- 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%
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Sensitivity and Specificity of the Sansa device to detect sleep disordered breathing compared to polysomnography 1 night
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (2)
Pulmonary & Sleep Specialists
🇺🇸Decatur, Georgia, United States
University of Michigan
🇺🇸Ann Arbor, Michigan, United States