Suggested Immobilization Test with heart rate variability to help diagnose restless legs
Diagnostic Accuracy of the Suggested Immobilization Test With Exploratory Heart Rate Variability Analysis for Restless Legs Syndrome in a Thai Population
NA · Siriraj Hospital · NCT07110961
This trial will test whether a Suggested Immobilization Test combined with heart rate variability measurements can help diagnose adults who have symptoms of restless legs syndrome during an in-lab sleep study.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 52 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Siriraj Hospital (other) |
| Locations | 1 site (Bangkok, Bangkok) |
| Trial ID | NCT07110961 on ClinicalTrials.gov |
What this trial studies
Participants who meet the International RLS Study Group clinical criteria and are scheduled for in-lab polysomnography will undergo a Suggested Immobilization Test while heart rate variability (HRV) is recorded for exploratory analysis. The protocol aims to capture objective physiologic signals that accompany urge-to-move symptoms and compare findings against standard clinical diagnosis. Patients with major physical limitations or pregnancy are excluded to avoid confounding or inability to complete the test. The approach seeks to distinguish true RLS from mimicking conditions by adding an objective physiologic layer to usual symptom-based diagnosis.
Who should consider this trial
Good fit: Adults meeting IRLSSG clinical criteria for restless legs who are scheduled for an in-lab polysomnography at the study center and do not have the listed exclusion conditions.
Not a fit: People with physical limitations such as stroke, dementia, hearing impairment, pregnant women, or anyone unable to attend the in-lab polysomnography likely would not benefit from this protocol.
Why it matters
Potential benefit: If successful, this approach could provide an objective diagnostic tool to improve accuracy and guide better treatment for people with restless legs.
How similar studies have performed: The Suggested Immobilization Test has been used previously to provoke RLS symptoms, but combining it with heart rate variability analysis for diagnostic use is exploratory and not yet established.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients who were appointed for an in-lab polysomnographic study and fit the clinical diagnosis criteria for restless leg syndrome based on International Restless Legs Syndrome Study Group (IRLSSG) Exclusion Criteria: * Patient with physical limitations including stroke, dementia or hearing impairment * Pregnant women
Where this trial is running
Bangkok, Bangkok
- Faculty of Medicine, Siriraj Hospital, Mahidol University — Bangkok, Bangkok, Thailand (RECRUITING)
Study contacts
- Study coordinator: Jindapa Srikajon, M.D.
- Email: jindapa.sri@mahidol.ac.th
- Phone: +66875932929
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Restless Leg Syndrome, restless leg syndrome, sleep, suggested immobilization test