Sleep Clinical Trial
Official title:
The RestEaze Ambulatory Sleep Monitor for Detection of Leg Movements During Sleep in Adults and Children With a Sleep Disturbance
This observational study will test and evaluate the RestEaze ambulatory sleep monitor for the detection and classification of leg movements during sleep (LMS) and other sleep measures.
| Status | Recruiting |
| Enrollment | 200 |
| Est. completion date | August 6, 2021 |
| Est. primary completion date | July 31, 2021 |
| Accepts healthy volunteers | |
| Gender | All |
| Age group | 5 Years to 75 Years |
| Eligibility |
Inclusion Criteria: - Ages between 5 -75 - General good health and ambulatory - Sleep complaint or other diagnosis that affects sleep (e.g. ADHD) with likely concomitant abnormal LMS requiring either HST or PSG - Reports no significant problems sleeping in a new bed and bedroom away from home - (If applicable) Parent or guardian available to spend the night with the child during the sleep study Exclusion Criteria: • Amputation that would preclude use of wrist actigraph or the RestEaze device |
| Country | Name | City | State |
|---|---|---|---|
| United States | Comprehensive Sleep Center | Milpitas | California |
| Lead Sponsor | Collaborator |
|---|---|
| Tanzen Medical Inc |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Algorithm | Development of analysis tools to validate RestEaze as a biomarker of leg movements of sleep | 1 year |
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