ACTIVE_NOT_RECRUITING

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

Conditions

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2023-11-15

Study Completion:2026-12

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:ACTIVE_NOT_RECRUITING

Study ID

NCT06076499

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.

Ages Eligible for Study:21 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Not specified

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.

Inclusion Criteria

Exclusion 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.

Contacts and Locations

Principal Investigator

Jessica Preciado, PhD

STUDY_DIRECTOR

Noctrix Health, Inc.

Study Locations (Sites)

Mark J Buchfuhrer, MD Office

Downey, California, 90241

United States

Sleep Medicine Specialists of California

San Ramon, California, 94583

United States

Neurocare, Inc.

Newton, Massachusetts, 02459

United States

Clayton Sleep Institute

Saint Louis, Missouri, 63123

United States

Ohio Sleep Medicine and Institute

Dublin, Ohio, 43017

United States

Bogan Sleep Consultants, LLC

Columbia, South Carolina, 29201

United States

Collaborators and Investigators

Sponsor: Noctrix Health, Inc.

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-11-15

Study Completion Date2026-12

Study Record Updates

Study Start Date2023-11-15

Study Completion Date2026-12

Terms related to this study

Keywords Provided by Researchers

Additional Relevant MeSH Terms

Restless Legs Syndrome