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

Last updated: September 24, 2024
Sponsor: Noctrix Health, Inc.
Overall Status: Active - Recruiting

Phase

N/A

Condition

Williams Syndrome

Manic Disorders

Dyskinesias

Treatment

NTX100

Clinical Study ID

NCT06076499
CT-06
  • Ages > 21
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. The subject possesses the necessary equipment, internet/phone accessibility, andcommunication ability to complete electronic questionnaires and respond toelectronic communications and phone calls from the research staff throughout thein-home portion of the study.

  2. The subject has signed a valid, IRB-approved informed consent form, can understandthe requirements of the study and instructions for device usage, and can converse inEnglish.

  3. Diagnosis of restless legs syndrome.

Exclusion

Exclusion Criteria:

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

Study Design

Total Participants: 325
Treatment Group(s): 1
Primary Treatment: NTX100
Phase:
Study Start date:
November 15, 2023
Estimated Completion Date:
December 31, 2026

Study Description

This study will assess the NTX100 TOMAC System's long-term effectiveness and safety in real-world settings. Using a prospective, observational approach, we'll monitor individuals receiving the system as part of standard care through five study visits, collecting data on clinical outcomes, device performance, and adverse events.

Connect with a study center

  • Mark J Buchfuhrer, MD Office

    Downey, California 90241
    United States

    Active - Recruiting

  • Sleep Medicine Specialists of California

    San Ramon, California 94583
    United States

    Active - Recruiting

  • Southern California Pulmonary and Sleep Disorders Medical Center

    Thousand Oaks, California 91361
    United States

    Site Not Available

  • Neurocare, Inc.

    Newton, Massachusetts 02459
    United States

    Active - Recruiting

  • Clayton Sleep Institute

    Saint Louis, Missouri 63123
    United States

    Active - Recruiting

  • Ohio Sleep Medicine and Institute

    Dublin, Ohio 43017
    United States

    Active - Recruiting

  • Bogan Sleep Consultants, LLC

    Columbia, South Carolina 29201
    United States

    Active - Recruiting

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