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

NCT ID: NCT04508595

Last Updated: 2020-08-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-08-08

Study Completion Date

2021-08-06

Brief Summary

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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

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Conditions

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Sleep

Study Design

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Observational Model Type

OTHER

Study Time Perspective

OTHER

Interventions

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RestEaze

Wearable band to detect leg movements of sleep

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

5 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tanzen Medical Inc

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Comprehensive Sleep Center

Milpitas, California, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Justin Brooks, MD,PhD

Role: CONTACT

7575811363

Facility Contacts

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Sanjay Agarwal, MD

Role: primary

408-942-0300

Other Identifiers

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TM-RE1-OBS-0001

Identifier Type: -

Identifier Source: org_study_id

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