The RestEaze Ambulatory Sleep Monitor for Detection of Leg Movements During Sleep in Adults and Children With a Sleep Disturbance

• Conditions: Sleep

• Registration Number: NCT04508595
• Lead Sponsor: Tanzen Medical Inc

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2020-08
• Study First Submitted: 2020-08-07
• Study First Submitted QC: 2020-08-07
• Last Update Submitted: 2020-08-07
• Study Start: 2020-08-08
• Study First Posted: 2020-08-11
• Last Update Posted: 2020-08-11
• Primary Completion: 2021-07-31
• Study Completion: 2021-08-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Algorithm	1 year	Development of analysis tools to validate RestEaze as a biomarker of leg movements of sleep

Trial Locations

Locations (1)

Comprehensive Sleep Center; 🇺🇸 Milpitas, California, United States