Recruiting

Observational Study

Sponsor:

Tanzen Medical Inc

Code:

NCT04508595

Conditions

Sleep

Eligibility Criteria

Sex: All

Age: 5 - 70+

Healthy Volunteers: Not accepted

Interventions

RestEaze

Study Details

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.

Conditions

Sleep

Study ID

NCT04508595

Start date

Aug 8, 2020

Status verified date

Aug, 2020

Completion date

Aug 6, 2021

Anticipated

Primary completion date

Jul 31, 2021

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 5 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

200 participants

Anticipated

Interventions and Outcome Measures

Interventions

RestEaze

Wearable band to detect leg movements of sleep

Primary outcome measure

  • Algorithm [ Time Frame: 1 year ]

Central Contacts and Locations

Central contacts

Justin Brooks, MD,PhD

7575811363jrybrooks@tanzenmed.com

Locations

Comprehensive Sleep Center

Recruiting

Milpitas, California, United States, 95035

Contacts

Sanjay Agarwal, MD

408-942-0300drsanjay@yahoo.com

More Information

Sponsor

Tanzen Medical Inc

Last update posted

Aug 11, 2020

Last verified

Aug, 2020

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Tanzen Medical Inc on 2020-08-11.