A Post-Market Study for Long-Term Effectiveness and Safety of the NTX100 for RLS (THRIVE)

Noctrix Health

Status: Enrolling

Conditions: Restless Legs Syndrome

Treatments: Device: NTX100

Study type: Observational

Funder types: Industry

Identifiers

NCT06076499

CT-06

Details and patient eligibility

About

Multi-center post-market, observational study to assess the long-term effectiveness and safety of the NTX100 TOMAC System for patients with Restless Legs Syndrome.

Full description

This study will assess the NTX100 TOMAC System's long-term effectiveness and safety in real-world settings. Using a prospective, observational approach, we'll monitor individuals receiving the system as part of standard care through five study visits, collecting data on clinical outcomes, device performance, and adverse events.

Enrollment: 325 estimated patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. The subject possesses the necessary equipment, internet/phone accessibility, and communication ability to complete electronic questionnaires and respond to electronic communications and phone calls from the research staff throughout the in-home portion of the study.
2. The subject has signed a valid, IRB-approved informed consent form, can understand the requirements of the study and instructions for device usage, and can converse in English.
3. Diagnosis of restless legs syndrome.

Exclusion criteria

1. The subject is unable or unwilling to comply with study requirements.