Response to an Investigational Device in Patients With Restless Legs Syndrome

NCT06866132 | Active Not Recruiting FDA Device

• 1 other identifier: CT-07
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Restless Legs Syndrome

Outcome Measures

Primary Outcomes (1)

• Mean Change in IRLS Rating Scale Score

  International Restless Legs Syndrome Study Group (IRLS) Rating Scale Score is a participant-rated questionnaire that rates RLS severity from 0-40, where 40 is the most severe. The mean change is assessed from study entry to Week 10.

  10 weeks

Secondary Outcomes (9)

• Mean change in the number of nights with RLS per week

  10 weeks

• Mean Change in MOS-II

  10 weeks

• Mean Change in MOS-I

  10 weeks

• Mean PGI-I score

  10 weeks

• Percent of Patients Reporting Much Improved or Very Much Improved

  10 weeks

Study Arms (1)

Investigational Device Protocol

EXPERIMENTAL

Participants will use the investigational noninvasive neuromodulation device as instructed over a period of 8 weeks (weeks 3 through 10).

Device: Investigational Noninvasive Neuromodulation Device

Interventions

Investigational Noninvasive Neuromodulation Device DEVICE

The investigational noninvasive neuromodulation device will be setup by the patient at bedtime and will be used every night. The IRB has established that the investigational device is non-significant risk.

Investigational Device Protocol

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- 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.
• \- 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.
• \- Subject has moderate-severe RLS symptoms as defined by a score of 15 or greater points on IRLS (International Restless Legs Syndrome Study Group Rating Scale) over the week prior to study entry.
• \- Subject reports that RLS symptoms caused awakenings or interfered with falling back asleep at least 3 nights per week during the month prior to study entry,
• \- Subject reports that RLS symptoms are most significant in lower legs and/or feet.

You may not qualify if:

• \- The subject has an active medical device implant anywhere in the body (including but not limited to pacemakers, spinal cord stimulators, deep brain stimulators).
• \- The subject has a metal implant at the site of the study device electrode application (not including knee replacements).
• \- The subject has been diagnosed with epilepsy or other seizure disorder.
• \- The subject has a moderate or severe cognitive disorder or mental illness that would affect his or her ability to participate in the study.
• \- The subject has a known allergy to device materials, electrode gel, polyurethane foam, or lycra (or a severe previous reaction to medical adhesives or bandages).
• \- Subject has any of the following at or near the location of device application: Acute injury, Cellulitis, Open sores
• \- The subject is unable or unwilling to comply with study requirements.
• \- The subject has a medical condition not listed above that may put them at risk.
• \- Subject has prior experience with any neurostimulation devices developed by the study sponsor
• \- On nights with no RLS symptoms (if any), subject reports typical sleep onset latency of \>60min.
• \- Subject has severe peripheral neuropathy affecting the lower legs and/or subject has neuropathy and is unable to clearly distinguish between symptoms of neuropathy and symptoms of RLS.
• \- Subject reports that bedtime is typically outside of 9pm-3am or reports that bedtime regularly varies by more than 4 hours, such as due to shift work.
• \- During initial device set-up, device does not properly fit the subject or calibrated intensity settings are outside of operational range

Sponsors & Collaborators

• Noctrix Health, Inc.: lead

Study Sites (1)

Noctrix Health Headquarters

Pleasanton, California, 94566, United States

Location

MeSH Terms

Conditions

Restless Legs Syndrome

Condition Hierarchy (Ancestors)

Nervous System Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Parasomnias; Mental Disorders

Study Officials

• Jonathan D Charlesworth, PhD

  Noctrix Health, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 3, 2025
• First Posted: March 10, 2025
• Study Start: March 11, 2025
• Primary Completion: August 4, 2025
• Study Completion: September 30, 2025
• Last Updated: August 15, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)