Clinical trial Recruiting at 1 site Interventional Ages 18 to 70

Suggested Immobilization Test with heart rate variability to help diagnose restless legs

Official title: Diagnostic Accuracy of the Suggested Immobilization Test With Exploratory Heart Rate Variability Analysis for Restless Legs Syndrome in a Thai Population

Run by Siriraj Hospital · NCT07110961 · Data updated 2026-11-12

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

Study typeInterventional
Ages18 Years to 70 Years
SexAll
Enrollment52 (estimated)
SponsorSiriraj Hospital
Academic / other
Locations1 site (Bangkok, Bangkok)
StatusRecruiting
StartedOctober 1, 2025
Main results expectedSeptember 30, 2026
Study endsDecember 31, 2026
Registry record updatedFebruary 13, 2026
Trial IDNCT07110961 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a 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.

Probably 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.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

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 gone: 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.

Who can join: the full rules

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 it's running

  • Faculty of Medicine, Siriraj Hospital, Mahidol University
    Bangkok, Bangkok, Thailand
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.