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

Tanzen Medical

Status: Unknown

Conditions: Sleep

Treatments: Diagnostic Test: RestEaze

Study type: Observational

Funder types: Industry

Identifiers

NCT04508595

TM-RE1-OBS-0001

Details and patient eligibility

About

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.

Enrollment: 200 estimated patients

Sex: All

Ages: 5 to 75 years old

Volunteers: No Healthy Volunteers

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