A Post-Market Study for Long-Term Effectiveness and Safety of the TOMAC System for RLS
Key facts
- Where
- Columbia, Downey, Dublin, Newton, Pittsburgh, San Ramon, and St Louis, United StatesSee the 7 sites
Where in United States
- Bogan Sleep Consultants, LLCColumbia, United StatesNo longer taking part
- Mark J Buchfuhrer, MD OfficeDowney, United StatesNo longer taking part
- Ohio Sleep Medicine and InstituteDublin, United StatesNo longer taking part
- Neurocare, Inc.Newton, United StatesNo longer taking part
- University of PittsburghPittsburgh, United StatesNo longer taking part
- Sleep Medicine Specialists of CaliforniaSan Ramon, United StatesNo longer taking part
- Clayton Sleep InstituteSt Louis, United StatesNo longer taking part
Trial details
- Who runs it
- Noctrix Health, Inc.
- Trial code
- NCT06076499
- Record updated
- 27 May 2026
- Original description
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.Read full original descriptionShow less
A Post-Market Observational Clinical Study to Determine the Long-Term Effectiveness and Safety of the Noctrix TOMAC (Tonic Motor Activation) System for the Treatment of Restless Legs Syndrome - The THRIVE Study
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.
Inclusion: 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.
Exclusion: The subject is unable or unwilling to comply with study requirements.