The Suggested Immobilization Test With Exploratory Heart Rate Variability Analysis for Diagnosis of Restless Legs Syndrome
Diagnostic Accuracy of the Suggested Immobilization Test With Exploratory Heart Rate Variability Analysis for Restless Legs Syndrome in a Thai Population
Siriraj Hospital
52 participants
Oct 1, 2025
INTERVENTIONAL
Conditions
Summary
Restless leg syndrome (RLS) is not uncommon and can also affect people's health and quality of life. Mainly, RLS is diagnosed based on clinical criteria subjectively. Sometimes it is difficult to differentiate between RLS and mimickers, especially in patients with comorbidities such as diabetes or parkinson's disease. We believe that using objective tests would facilitate accuracy in RLS diagnosis, which leads to proper management of patients.
Eligibility
Inclusion Criteria1
- 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 Criteria2
- Patient with physical limitations including stroke, dementia or hearing impairment
- Pregnant women
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Interventions
The Suggested Immobilization Test (SIT) is a provocative test. RLS symptoms (urge to move the leg and leg paresthesia) are primarily observed during wakefulness, especially at rest, in the evening, and/or during the night. During the test, the patient remains in a bed (or a reclining chair), at a 45° angle with legs outstretched. Originally, the SIT only quantified leg motor activity. Since 2002, it also includes the assessment of leg discomfort, which is estimated by the patient every 5 min, on a 100-mm horizontal visual analogue scale. Leg movements are quantified using surface electromyography (EMG) from bilateral anterior tibialis muscles. Using these pathological thresholds, the clinical RLS/WED diagnosis is correctly predicted in 88% of subjects with a sensitivity of 82% and a specificity of 100%. Heart rate variability was recorded though ECG II channel.
Locations(1)
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NCT07110961