Restless Legs Syndrome Trial, Recruiting

Written by an AI model from the ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• You have signed a consent form approved by an ethics board, can understand the study requirements and device instructions, and can communicate in English.
• You have been officially diagnosed by a doctor with primary restless legs syndrome (RLS).
• You are willing to keep your medications and treatments (such as RLS medications, antidepressants, sleep aids, or CPAP) at the same dose and schedule throughout the study.
• Your RLS symptoms are mainly felt in your lower legs and/or feet.
• Your RLS symptoms have caused you to wake up or made it hard to fall back asleep at least 3 nights per week in the past month.
• You have access to a phone or internet, and the necessary devices, to complete online questionnaires and stay in contact with the research team from home.
• Your RLS symptoms are rated as moderate to severe, meaning you score 15 points or higher on a standard RLS symptom rating scale.
• You are 21 years of age or older.

Who may not be able to join:

• You have an active medical device implanted anywhere in your body, such as a pacemaker, spinal cord stimulator, or deep brain stimulator.
• You have a metal implant in the area of your body where the study device's electrodes would be placed (knee replacements are generally not a concern — confirm with trial site).
• You have been diagnosed with epilepsy or any other seizure disorder.
• You have a moderate or severe cognitive (thinking/memory) disorder or mental illness that could affect your ability to take part in the study.
• You have a known allergy to the device materials, electrode gel, polyurethane foam, or lycra, or you have had a severe reaction to medical adhesives or bandages in the past.
• You have an acute injury, skin infection (cellulitis), or open sores at or near where the device would be applied.
• You are unable or unwilling to follow the study requirements.
• You have another medical condition not listed here that may put you at risk by participating.
• You have previously used a neurostimulation device made by the company running this study.
• You have another sleep disorder (separate from RLS) that is currently significantly disrupting your sleep (note: sleep apnea that is well-controlled with CPAP would generally not exclude you — confirm with trial site).
• On nights when you have no RLS symptoms, it typically takes you more than 60 minutes to fall asleep.
• You have severe nerve damage (peripheral neuropathy) in your lower legs, or you have neuropathy and cannot clearly tell the difference between neuropathy symptoms and RLS symptoms.
• Your usual sleep schedule is not mainly during nighttime hours (for example, you do not typically go to bed between 8:00pm and 2:00am and wake up between 4:00am and 11:00am), or your bedtime regularly shifts by more than 4 hours, such as due to shift work.
• You are currently on a medication dose or schedule that is unstable or inconsistent and likely to affect your RLS symptoms or sleep.
• You have changed the dose or schedule of any medication or treatment likely to affect your RLS symptoms or sleep within the past 30 days.
• During the initial device setup, the device does not fit you properly or the settings fall outside the device's working range.

Important: Always verify eligibility with the trial site directly before applying.