Status:
ACTIVE_NOT_RECRUITING
A Post-Market Study for Long-Term Effectiveness and Safety of the NTX100 for RLS
Lead Sponsor:
Noctrix Health, Inc.
Conditions:
Restless Legs Syndrome
Eligibility:
All Genders
21+ years
Brief 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.
Detailed 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 ...
Eligibility Criteria
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
- 1\. The subject is unable or unwilling to comply with study requirements.
Key Trial Info
Start Date :
November 15 2023
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 1 2026
Estimated Enrollment :
325 Patients enrolled
Trial Details
Trial ID
NCT06076499
Start Date
November 15 2023
End Date
December 1 2026
Last Update
July 24 2025
Active Locations (6)
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1
Mark J Buchfuhrer, MD Office
Downey, California, United States, 90241
2
Sleep Medicine Specialists of California
San Ramon, California, United States, 94583
3
Neurocare, Inc.
Newton, Massachusetts, United States, 02459
4
Clayton Sleep Institute
St Louis, Missouri, United States, 63123