NCT04508595

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 7, 2020

Completed
1 day until next milestone

Study Start

First participant enrolled

August 8, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 11, 2020

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2021

Completed
6 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 6, 2021

Completed
Last Updated

August 11, 2020

Status Verified

August 1, 2020

Enrollment Period

12 months

First QC Date

August 7, 2020

Last Update Submit

August 7, 2020

Conditions

Sleep

Outcome Measures

Primary Outcomes (1)

  • Algorithm

    Development of analysis tools to validate RestEaze as a biomarker of leg movements of sleep

    1 year

Interventions

RestEazeDIAGNOSTIC_TEST

Wearable band to detect leg movements of sleep

Eligibility Criteria

Age5 Years - 75 Years
Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Outpatients presenting to sleep medicine clinic for evaluation.

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Comprehensive Sleep Center

Milpitas, California, 95035, United States

RECRUITING

Central Study Contacts

Justin Brooks, MD,PhD

CONTACT

7575811363jrybrooks@tanzenmed.com

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
OTHER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 7, 2020

First Posted

August 11, 2020

Study Start

August 8, 2020

Primary Completion

July 31, 2021

Study Completion

August 6, 2021

Last Updated

August 11, 2020

Record last verified: 2020-08

Data Sharing

IPD Sharing
Will not share

Locations

US(1)