Form, Fit and Function Feasibility Study
Noctrix Health, Inc.
Summary
This study assesses the tolerability, safety, and impact of an investigational medical device on restless legs syndrome symptoms. The IRB has established that the investigational device is non-significant risk.
Description
In this 12-week study, participants complete a 1-week baseline (no intervention) followed by 1-week Tonic Motor Activation (TOMAC) therapy (30-minutes of stimulation). Next, participants complete 4-weeks of Extended Duration (XD-) TOMAC. Then, participants will complete investigational TOMAC medical device interventions for 6-weeks in a pseudo-randomized order.
Eligibility
- Age range
- 21+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * 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 * Subject has received a medical diagnosis of primary restless legs syndrome (RLS). * Subject agrees to not change dosage or schedule of any medications that are known to impact RLS symptoms during the study, including RLS medications, antidepressants, sleep medications, or sedative antihistamines or treatments such as CPAP (continuous positive airway pressure). * Subject reports that RLS symptoms are…
Interventions
- DeviceInvestigational Extended Duration (XD-) TOMAC Therapy
The investigational noninvasive neuromodulation device will be setup by the participant at bedtime and used to provide Extended Duration Tonic Motor Activation (XD-TOMAC) every night. The IRB has established that the investigational device is non-significant risk.
- DeviceTonic Motor Activation (TOMAC) Therapy
The noninvasive neuromodulation device will be setup by the participant to be used for TOMAC 30-minute stimulation therapy sessions as needed during the 2nd week of the study and as appropriate for the remainder of the study. The IRB has established that the device is non-significant risk.
Location
- Noctrix Health HeadquartersPleasanton, California