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