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New device offers Drug-Free hope for restless legs sufferers

NCT ID NCT06076499

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

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 325 people

The number the study aims to enrol. It can still change while the study runs.

Started

Nov 2023

Expected to finish

Jul 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

The study population will consist of adults who meet the inclusion and exclusion criteria.

Ages

21 years and older

Sex

Anyone

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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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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