A Post-Market Study for Long-Term Effectiveness and Safety of the TOMAC System for RLS

Running, not enrolling

Conditions studied: Restless Legs Syndrome

In brief

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.

Key facts

Study ID

NCT06076499

Run by

Noctrix Health, Inc.

People needed

325

Starts

2023-11-15

Expected to finish

2027-07-01

Last updated by the study team

2026-05-27

Who can join

Age: 21 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.
• 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.
• Diagnosis of restless legs syndrome.

You may not qualify if…

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

Where it is running

• Mark J Buchfuhrer, MD Office — Downey, California, United States
• Sleep Medicine Specialists of California — San Ramon, California, United States
• Neurocare, Inc. — Newton, Massachusetts, United States
• Clayton Sleep Institute — St Louis, Missouri, United States
• Ohio Sleep Medicine and Institute — Dublin, Ohio, United States
• University of Pittsburgh — Pittsburgh, Pennsylvania, United States
• Bogan Sleep Consultants, LLC — Columbia, South Carolina, United States

Full record on ClinicalTrials.gov

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