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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorSiriraj Hospital

About this trial

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 criteria

This trial accepts healthy volunteers

Qualifiers

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)

Disqualifiers

Patient with physical limitations including stroke, dementia or hearing impairment

Pregnant women

Trial design

Design model

Single group

Treatments tested in this trial

  • A suggested immobilization test (SIT)

    Procedure/Surgery

    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.

Treatment groups

52 Participants
are divided into 1 treatment group
Group A: Clinical diagnosed restless leg syndromeExperimental treatment 1 intervention

Trial outcomes

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.

Time frame
During intervention

Secondary outcomes

1

Occurence of advense events from a suggested immobilization test

discomfort or any unconfotable feeling during the test will be recorded.

Time frame
During intervention
2

Heart rate variability changes during SIT

Heart Rate Variability Assessment Electrocardiographic signals were recorded continuously during a baseline resting period preceding the SIT and throughout the test. HRV analysis was performed using validated software following artifact correction and manual inspection of R-R intervals. Time-domain parameters included the root mean square of successive differences (RMSSD) and the standard deviation of normal-to-normal intervals (SDNN). Frequency-domain parameters included low-frequency (LF) power, high-frequency (HF) power, and the LF/HF ratio. HRV parameters during early (first 5 minutes) and the late SIT period (last 5 minutes) were compared between participants with and without RLS. HRV analysis was predefined as an exploratory secondary outcome.

Time frame
During the SIT prior to sleep test

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.