A Post-Market Study for Long-Term Effectiveness and Safety of the NTX100 for RLS

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.

Conditions

Restless Legs Syndrome

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Study Overview

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Study Details

Study overview

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.

A Post-Market Observational Clinical Study to Determine the Long-Term Effectiveness and Safety of the Noctrix NTX100 TOMAC (Tonic Motor Activation) System for the Treatment of Restless Legs Syndrome - The THRIVE Study

A Post-Market Study for Long-Term Effectiveness and Safety of the NTX100 for RLS

Condition
Restless Legs Syndrome
Intervention / Treatment

-

Contacts and Locations

Downey

Mark J Buchfuhrer, MD Office, Downey, California, United States, 90241

San Ramon

Sleep Medicine Specialists of California, San Ramon, California, United States, 94583

Newton

Neurocare, Inc., Newton, Massachusetts, United States, 02459

Saint Louis

Clayton Sleep Institute, Saint Louis, Missouri, United States, 63123

Dublin

Ohio Sleep Medicine and Institute, Dublin, Ohio, United States, 43017

Columbia

Bogan Sleep Consultants, LLC, Columbia, South Carolina, United States, 29201

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

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

Ages Eligible for Study

21 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Noctrix Health, Inc.,

Jessica Preciado, PhD, STUDY_DIRECTOR, Noctrix Health, Inc.

Study Record Dates

2026-12