Autonomic Assessment in Patients With Restless Legs Syndrome

Kocaeli Derince Education and Research Hospital

Status: Completed

Conditions: Restless Legs Syndrome

Study type: Observational

Funder types: Other

Identifiers

NCT04906486

2011-KAEK-27/2020-E.2000173683

Details and patient eligibility

About

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.

Full 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.

Enrollment: 155 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

155 participants in 2 patient groups

Observational: Patients with restless legs syndrome

Description:

A total of 70 patients who diagnosed with primary restless legs syndrome according to the five essential criteria as established by the International Restless Legs Syndrome Study Group.

Observational: Healthy controls

Description:

The control group consisted of 85 age- and gender-matched healthy volunteers.