Active — Not RecruitingNot Applicable

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

United States325 participantsStarted 2023-11-15

Plain-language summary

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.

Who can participate

Age range21 Years

SexALL

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Inclusion criteria

✓. 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.

What they're measuring

Primary Effectiveness Endpoint

Timeframe: 1 year

Trial details

NCT IDNCT06076499

SponsorNoctrix Health, Inc.

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2026-07

View on ClinicalTrials.gov More Restless Legs Syndrome trials