Sleep-Disordered Breathing
Conditions
Brief summary
The objective of this study is to evaluate the performance of the Sansa device for the diagnosis of sleep disordered breathing.
Interventions
DEVICESansa device
The Sansa device will be used during a single overnight polysomnography study.
Sponsors
Huxley Medical, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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%
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Sensitivity and Specificity of the Sansa device to detect sleep disordered breathing compared to polysomnography | 1 night |
Countries
United States
Outcome results
None listed