Restless Legs Syndrome
Conditions
Keywords
restless legs syndrome, autonomic dysfunction, dysautonomia, SCOPA-AUT questionnaire
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.
Interventions
None listed
Sponsors
Kocaeli Derince Education and Research Hospital
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
Countries
Turkey (Türkiye)
Outcome results
None listed