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

Last updated: August 7, 2020
Sponsor: Tanzen Medical Inc
Overall Status: Active - Recruiting

Phase

N/A

Condition

Narcolepsy

Sleep Disorders

Treatment

N/A

Clinical Study ID

NCT04508595
TM-RE1-OBS-0001
  • Ages 5-75
  • All Genders

Study 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

Inclusion Criteria:

  • Ages between 5 -75

  • General good health and ambulatory

  • Sleep complaint or other diagnosis that affects sleep (e.g. ADHD) with likelyconcomitant 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 duringthe sleep study

Exclusion

Exclusion Criteria:

• Amputation that would preclude use of wrist actigraph or the RestEaze device

Study Design

Total Participants: 200
Study Start date:
August 08, 2020
Estimated Completion Date:
August 06, 2021

Connect with a study center

  • Comprehensive Sleep Center

    Milpitas, California 95035
    United States

    Active - Recruiting

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