Vibrating device may calm restless legs during dialysis

NCT ID NCT06889324

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

70 people

The number who actually took part.

Started

Jun 2025

Expected to finish

Sep 2025

An estimate. End dates often move.

Lead sponsor

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

20 to 60 years

Sex

Anyone

Healthy volunteers

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

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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