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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04508595
Enrollment
200
Registered
2020-08-11
Start date
2020-08-08
Completion date
2021-08-06
Last updated
2020-08-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sleep

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.

Interventions

DIAGNOSTIC_TESTRestEaze

Wearable band to detect leg movements of sleep

Sponsors

Tanzen Medical Inc
Lead SponsorINDUSTRY

Study design

Observational model
OTHER
Time perspective
OTHER

Eligibility

Sex/Gender
ALL
Age
5 Years to 75 Years

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

Design outcomes

Primary

MeasureTime frameDescription
Algorithm1 yearDevelopment of analysis tools to validate RestEaze as a biomarker of leg movements of sleep

Countries

United States

Contacts

Primary ContactJustin Brooks, MD,PhD
jrybrooks@tanzenmed.com7575811363

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026