Long-term effectiveness and safety of NTX100 for 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
This study is testing how well and safely the NTX100 system works for people with Restless Legs Syndrome over a long period of time.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 325 (estimated) |
| Ages | 21 Years and up |
| Sex | All |
| Sponsor | Noctrix Health, Inc. Industry-sponsored |
| Locations | 6 sites (Downey, California and 5 other locations) |
| Trial ID | NCT06076499 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the long-term effectiveness and safety of the NTX100 TOMAC System in patients diagnosed with Restless Legs Syndrome. Conducted across multiple centers, the study will monitor participants through five visits, collecting data on clinical outcomes, device performance, and any adverse events. Participants will use the system as part of their standard care, allowing for real-world assessment of its impact.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals diagnosed with Restless Legs Syndrome who can comply with study requirements and communicate effectively in English.
Not a fit: Patients who are unable or unwilling to comply with study requirements may not receive any benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the long-term management of Restless Legs Syndrome, potentially improving patient quality of life.
How similar studies have performed: Other studies assessing similar devices for Restless Legs Syndrome have shown promising results, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion 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. Exclusion Criteria: 1. The subject is unable or unwilling to comply with study requirements.
Where this trial is running
Downey, California and 5 other locations
- Mark J Buchfuhrer, MD Office — Downey, California, United States (Recruiting)
- Sleep Medicine Specialists of California — San Ramon, California, United States (Recruiting)
- Neurocare, Inc. — Newton, Massachusetts, United States (Recruiting)
- Clayton Sleep Institute — Saint Louis, Missouri, United States (Recruiting)
- Ohio Sleep Medicine and Institute — Dublin, Ohio, United States (Recruiting)
- Bogan Sleep Consultants, LLC — Columbia, South Carolina, United States (Recruiting)
Study contacts
- Study coordinator: Jessica Preciado, PhD
- Email: jessica@noctrixhealth.com
- Phone: 5103331437
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.