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

Launched by NOCTRIX HEALTH, INC. · Oct 6, 2023

Keywords

ClinConnect Summary

This clinical trial is studying the long-term effectiveness and safety of a device called the NTX100 TOMAC System for people with Restless Legs Syndrome (RLS). RLS is a condition that causes uncomfortable sensations in the legs and an urge to move them, often disrupting sleep. The study is taking place at multiple centers and aims to gather information on how well this device works over time for patients who have been diagnosed with RLS.

To participate in this study, individuals must be between the ages of 76 and 70, have the necessary equipment to complete online questionnaires, and be able to communicate in English. Participants should also be willing to follow the study's requirements. If chosen, they can expect to use the NTX100 device at home while providing feedback through electronic questionnaires and phone calls with the research team. This study will help researchers understand how the device affects RLS symptoms and its overall safety for patients.

Gender

ALL

Eligibility 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.