Restless Legs Syndrome Trial, Recruiting
Who may be able to join
AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI
Who might be able to join this trial:
- You are 18 years of age or older
- You are pregnant and between 21 and 26 weeks along at the time of joining the study
- You are carrying one baby, with no known problems found with the baby's development
- You have been diagnosed with Restless Legs Syndrome (RLS) by a sleep specialist, who has confirmed it is definitely RLS and not another condition that can look like it
- You are willing and able to give your agreement to take part in the study
- You are able and willing to follow all study requirements, including using a device, filling in questionnaires, keeping a diary of how you use the treatment, and attending follow-up appointments until 3 months after your baby is born
Who may not be able to join:
- You have had preterm (early) labor in the past
- Any problems with your baby's development were found before joining the study
- You have a pre-existing condition affecting your muscles or nerves that affects your balance or the way you walk
- You have serious nerve damage in your lower legs
- You have epilepsy or have had seizures in the past
- You have a history of deep vein thrombosis (blood clots in a vein)
- You have a circulatory condition that would make it unsafe to use the nerve stimulation device used in this study (confirm with trial site)
- You have a skin condition in the area where the device would be placed on your body
- You have a known allergy to the materials the device is made from
- You have another serious sleep disorder, such as severe untreated sleep apnea or severe insomnia not related to RLS, that is not being adequately managed
- You have previously used this study device or any similar nerve stimulation device to treat RLS
- You have an active medical implant in your body, such as a pacemaker or spinal cord stimulator
- You are currently receiving dialysis treatment
- You have a serious mental health condition, such as bipolar disorder, psychosis, or severe anxiety or depression, that might make it hard to follow the study plan or report your symptoms accurately
- You have any other health condition that the study team believes could put you at risk or prevent you from fully taking part (confirm with trial site)
- You are unable or unwilling to use the device safely on your own
- You are unable to reliably attend follow-up visits or complete the self-reported diaries
Important: Always verify eligibility with the trial site directly before applying.
Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.
Contact this trial
Phone: 4014444000
Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.
GP referral letter
Print a one-page summary to share with your doctor.
Trial details
Where this trial is recruiting
Primary endpoints
Acceptability of Intervention Measure (AIM) Score; Intervention Appropriateness Measure (IAM) Score; Feasibility of Intervention Measure (FIM) Score
Can't join this trial?
Data last synced from ClinicalTrials.gov: 28 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.