Could a Light-and-Vibe combo soothe restless legs in diabetes?
NCT ID NCT07308080
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests a drug-free approach for restless leg syndrome (RLS) in people with type 2 diabetes. 42 adults aged 50-65 will receive either vibration, near-infrared light, or both, plus stretching, for 4 weeks. Researchers will measure changes in pain, sleep quality, and RLS severity to see if the combination works better than each therapy alone.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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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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About 42 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Dec 2025
An estimate. Start dates often move.
- Expected to finish
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May 2026
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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50 to 65 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.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: Patients of age 50-65 years Both male and female patients with Type II diabetes Patients with a diagnosis of diabetes at least 6 months ago RLS (score of 11+ on the RLS scale) Patients meeting the four key RLS diagnosis criteria will be included in the study. Criterion is: Urge to move due to uncomfortable leg sensations, symptoms worsening at rest, symptoms relief with movement ,greater symptom severity in the evening or at night. Willingness to provide informed consent . Exclusion Criteria: Patients using analgesics, psychiatric, or neurological medications. Patients with any malignancies, neurological, skeletal, or vascular disorders History of drug abuse. Ongoing RLS treatments (e.g. vibration therapy, massage). Severe cognitive impairment. Pregnancy or lactation. Conditions contraindicating NIR or vibration therapy
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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.
How to take part
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
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