Active — Not RecruitingNot Applicable

Response to an Investigational Device in Patients With Restless Legs Syndrome

United States20 participantsStarted 2025-03-11

Plain-language 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.

Who can participate

Age range21 Years

SexALL

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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.
✓. \- 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.

Exclusion criteria

✕. \- 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.

What they're measuring

Mean Change in IRLS Rating Scale Score

Timeframe: 10 weeks

Trial details

NCT IDNCT06866132

SponsorNoctrix Health, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-08-04

View on ClinicalTrials.gov More Restless Legs Syndrome trials