Status:
UNKNOWN
The RestEaze Ambulatory Sleep Monitor for Detection of Leg Movements During Sleep in Adults and Children With a Sleep Disturbance
Lead Sponsor:
Tanzen Medical Inc
Conditions:
Sleep
Eligibility:
All Genders
5-75 years
Brief Summary
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.
Eligibility Criteria
Inclusion
- 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
- • Amputation that would preclude use of wrist actigraph or the RestEaze device
Key Trial Info
Start Date :
August 8 2020
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
August 6 2021
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT04508595
Start Date
August 8 2020
End Date
August 6 2021
Last Update
August 11 2020
Active Locations (1)
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1
Comprehensive Sleep Center
Milpitas, California, United States, 95035