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The Suggested Immobilization Test With Exploratory Heart Rate Variability Analysis for Diagnosis of Restless Legs Syndrome

NCT07110961 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 52

Last updated 2026-02-13

No results posted yet for this study

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.

Conditions

  • Restless Leg Syndrome

Interventions

PROCEDURE

A suggested immobilization test (SIT)

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.

Sponsors & Collaborators

  • Siriraj Hospital

    lead OTHER

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-10-01
Primary Completion
2026-09-30
Completion
2026-12-31

Countries

  • Thailand

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07110961 on ClinicalTrials.gov