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

NCT07110961 | Recruiting

• 1 other identifier: 645/2568(IRB4)
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

restless leg syndrome; sleep; suggested immobilization test

Outcome Measures

Primary Outcomes (1)

• Correlation between clinical diagnosis based on criteria and results from a suggested immobilization test

  Between-group and correlation analyses between categorical and continuous data were corrected using Spearman's rank correlation.

  During intervention

Secondary Outcomes (2)

• Occurence of advense events from a suggested immobilization test

  During intervention

• Heart rate variability changes during SIT

  During the SIT prior to sleep test

Study Arms (1)

Clinical diagnosed restless leg syndrome

EXPERIMENTAL

Participants with appointment of sleep test and clinical diagnosed restless leg syndrome according to International Restless Legs Syndrome Study Group (IRLSSG) are reruited and undergo a suggested immobilization test before the standard polysomnographic study.

Procedure: A suggested immobilization test (SIT)

Interventions

A suggested immobilization test (SIT) PROCEDURE

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.

Clinical diagnosed restless leg syndrome

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• Patient with physical limitations including stroke, dementia or hearing impairment
• Pregnant women

Sponsors & Collaborators

• Siriraj Hospital: lead

Study Sites (1)

Faculty of Medicine, Siriraj Hospital, Mahidol University

Bangkok, Bangkok, 10700, Thailand

RECRUITING

Related Links

• Related Info

MeSH Terms

Conditions

Restless Legs Syndrome

Condition Hierarchy (Ancestors)

Nervous System Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Parasomnias; Mental Disorders

Central Study Contacts

Jindapa Srikajon, M.D.

CONTACT

+66875932929; jindapa.sri@mahidol.ac.th

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Model Details: All participants will undergo a suggested immobilization test on the same day of the sleep test appointment.

Study Record Dates

• First Submitted: July 25, 2025
• First Posted: August 8, 2025
• Study Start: October 1, 2025
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: February 13, 2026

Record last verified: 2026-02

Locations

TH (1)