Autonomic Assessment in Patients With Restless Legs Syndrome

Completed

• Conditions: Restless Legs Syndrome

• Registration Number: NCT04906486
• Lead Sponsor: Kocaeli Derince Education and Research Hospital

Brief Summary

Restless legs syndrome (RLS) is a sensorimotor, sleep-related disorder characterized by urgency to move the legs during inactivity or resting state. Although the exact mechanism is not clearly understood, sleep disturbances and dopamine deficiency may regarded as a potential contributing factor for autonomic dysfunction. The objective of the study is to evaluate autonomic functions and determine possible associations between autonomic dysfunction with clinical factors in patients with RLS.

Detailed Description

Restless legs syndrome (RLS) also known as Willis- Ekbom disease, is a common sensorimotor, sleep-related disorder characterized by an unpleasant feeling with urgency to move the legs (or less commonly the arms) during inactivity or resting state.

Although, the clinical importance of autonomic involvement in patients with restless legs syndrome (RLS) remains incompletely understood, sleep disturbances and dopamine deficiency may regarded as a potential contributing factor for autonomic dysfunction.

Previous reports have described autonomic impairment including changes in nocturnal blood pressure and heart rate variability (HRV), gastrointestinal, urinary and sexual dysfunction in patients with RLS. Despite many studies about electrophysiological autonomic changes in RLS, number of studies exploring autonomic functions by using Scales for Outcomes in Parkinson's disease-Autonomic questionnaire (SCOPA-AUT) are limited.

In this study, the investigators plan to compare the presence of autonomic symptoms by using Scales for Outcomes in Parkinson's disease-Autonomic (SCOPA-AUT) questionnaire in drug- naive RLS patients to healthy controls. In addition, the investigators aim to evaluate possible associations between autonomic dysfunction with clinical factors in patients with RLS.

Study Timeline

• Study Start: 2020-11-12
• Primary Completion: 2021-04-10
• Study Completion: 2021-04-12
• Status Verified: 2021-05
• Study First Submitted: 2021-05-22
• Study First Submitted QC: 2021-05-26
• Last Update Submitted: 2021-05-26
• Study First Posted: 2021-05-28
• Last Update Posted: 2021-05-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 155

Inclusion Criteria

For the patient group:

• age >18, <65
• newly diagnosed, drug naive patients with primary restless legs syndrome

For the control group:

• age >18, <65
• participants without chronic systemic disorder

Exclusion Criteria

• previous diagnosis of primary RLS
• subjects with secondary RLS
• concomitant use of drugs that could interfere with autonomic nervous system
• individuals with a known acute/chronic medical disease
• individuals with a minimental test score < 25/30
• sleep disorders that could affect test performances

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Age (years)	6 months	Correlation between autonomic dysfunction and age (years) in patients with restless legs syndrome noted.
Age of disease onset (years)	6 months	Correlation between autonomic dysfunction and age of disease onset (years) in patients with restless legs syndrome noted.
Disease duration (years)	6 months	Correlation between autonomic dysfunction and disease duration (years) in patients with restless legs syndrome noted.
Scales for Outcomes in Parkinson's disease-Autonomic questionnaire (SCOPA-AUT) (points)	6 months	Presence and severity of autonomic dysfunction noted by using Scales for Outcomes in Parkinson's disease-Autonomic questionnaire \[SCOPA-AUT, including six domains (gastrointestinal,urinary, cardiovascular, thermoregulatory, pupillomotor, and sexual) with 25-items and a 4 -point Likert-type scale ranging from 0 to 69\] in patients with restless legs syndrome vs. healthy controls.
Disease severity (as measured by International Restless Legs Scale) (points)	6 months	Correlation between autonomic dysfunction and disease severity (as measured by International Restless Legs Scale,5-point Likert-type scale ranging from 0 to 40; mild= 0-10; moderate= 11-20; severe= 21-30; very severe= 31-40) in patients with restless legs syndrome noted.
Excessive daytime sleepiness (as measured by Epworth Sleepiness scale) (points)	6 months	Correlation between autonomic dysfunction and excessive daytime sleepiness \[as measured by Epworth Sleepiness scale ,8-items with a 4-point Likert-type scale ( 0=would never doze,1=slight chance,2=moderate chance, 3= high chance) ranging from 0 to 24 points\] in patients with restless legs syndrome noted.
Body mass index (kg/m2)	6 months	Correlation between autonomic dysfunction and body mass index (kg/m2, as calculated by dividing weight in kilograms by their height in metres squared) in patients with restless legs syndrome noted.

Trial Locations

Locations (1)

Sehnaz Basaran; 🇹🇷 İ̇zmi̇t, Marmara, Turkey