Vibrating device may calm restless legs during dialysis
NCT ID NCT06889324
First seen Jun 26, 2026 ยท Last updated Jun 26, 2026
Summary
This study tests whether a simple vibration device applied to the calf muscles can reduce the severity of restless legs syndrome and improve sleep quality in people undergoing hemodialysis. Seventy participants will receive vibration therapy for 10 minutes, twice a week for one month, during their dialysis sessions. Researchers will compare their symptoms to those who do not receive the therapy.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- vibration therapy (mechanical vibrations applied to calf muscles via a Thrive vibrator device)
- What this could lead to
- If it works, this could offer a simple, drug-free way to reduce restless legs symptoms and improve sleep for people on dialysis.
- What could go wrong
- This is a small, early-stage trial with only 70 participants and no blinding, so results may not be reliable or apply to everyone. The treatment is short-term (one month), so any benefits might not last.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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70 people
The number who actually took part.
- Started
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Jun 2025
- Expected to finish
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Sep 2025
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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20 to 60 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Patients passing at least three months after first their hemodialysis * Patients who are receiving two or more HD sessions a week, to facilitate patient follow-up. * Patients who are willing to participate, because the patients' participation is voluntary. * Patients who are alert and able to communicate verbally, to make the program applicable and facilitate the data collection. Exclusion Criteria: * Emergency hemodialysis patients, to avoid mal-efficient (apply the program in a harmless manner). * Intake of drugs for restless leg syndrome and sleep disturbances. * Using vibration and massage therapy at home * Recent history of deep vein thrombosis or other vascular complications. * Patients who are unable to communicate, because the patients' communication is an essential part of data collection. * Patients with severe cardiovascular disorders such as unstable angina, recent myocardial infarction or severe heart failure, because the application of the program may increase cardiovascular stress, which may pose a risk to these patients.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Al-Sadder Medical City
Najaf, Al Kufa, 54003, Iraq
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Other studies related to the condition(s) this trial covers.
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