New device offers Drug-Free hope for restless legs sufferers

NCT ID NCT06076499

Ongoing Symptom relief Sponsor: Noctrix Health, Inc. Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study is checking the long-term safety and effectiveness of a device called the Noctrix TOMAC System for people with restless legs syndrome. The device uses mild nerve stimulation to calm leg discomfort. Researchers are following 325 patients for one year to see if symptoms improve and if any side effects appear. It's an observational study, meaning participants use the device as part of their normal care, and no new treatment is being tested.

What this could mean

Our plain-language read of the trial. This is informational only — not medical advice or a prediction.

Active substance: NTX100 TOMAC System (non-invasive nerve stimulation device)
What this could lead to: If successful, this could confirm the TOMAC device as a safe, long-term option to ease restless legs symptoms without medication.
What could go wrong: This is an observational study, not a controlled trial, so results may be less definitive. The device may not work for everyone, and long-term side effects are still being tracked.

This is an AI summary of the original study and may miss details. Read our disclaimer.

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Conditions

The condition(s) this trial relates to.

restless legs syndrome

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

RESTLESS LEGS SYNDROME

Contacts and locations

Locations

Bogan Sleep Consultants, LLC

Columbia, South Carolina, 29201, United States
Clayton Sleep Institute

St Louis, Missouri, 63123, United States
Mark J Buchfuhrer, MD Office

Downey, California, 90241, United States
Neurocare, Inc.

Newton, Massachusetts, 02459, United States
Ohio Sleep Medicine and Institute

Dublin, Ohio, 43017, United States
Sleep Medicine Specialists of California

San Ramon, California, 94583, United States
University of Pittsburgh

Pittsburgh, Pennsylvania, 15232, United States

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