Clinical trial NCT04906486: Autonomic Assessment in Patients With Restless Legs Syndrome
Official title: Clinical Assessment of Autonomic Functions by SCOPA-Autonomic Questionnaire in Patients With Restless Legs Syndrome: A Prospective Study in a Tertiary Care Hospital
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Restless Legs Syndrome
Keywords: restless legs syndrome
autonomic dysfunction
dysautonomia
SCOPA-AUT questionnaire
Lead sponsor: Kocaeli Derince Education and Research Hospital
Sponsor class: OTHER
First posted: 2021-05-28
Enrollment: 155
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients were selected from a tertiary care neurology outpatient clinic. Age and gender matched control group obtained from the family members of the tertiary care hospital's staff.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Scales for Outcomes in Parkinson's disease-Autonomic questionnaire (SCOPA-AUT) (points)
timeFrame: 6 months
measure: Age (years)
timeFrame: 6 months
measure: Age of disease onset (years)
timeFrame: 6 months
measure: Disease duration (years)
timeFrame: 6 months
measure: Disease severity (as measured by International Restless Legs Scale) (points)
timeFrame: 6 months
measure: Excessive daytime sleepiness (as measured by Epworth Sleepiness scale) (points)
timeFrame: 6 months
measure: Body mass index (kg/m2)
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: İzmit
country: Turkey
facility: Sehnaz Basaran
state: Marmara
city: İ̇zmi̇t
country: Turkey
facility: Sehnaz Basaran
state: Marmara
Study officials:
affiliation: KOCAELİ DERİNCE EDUCATION AND RESEARCH HOSPİTAL DEPARTMENT OF NEUROLOGY
name: SEHNAZ BASARAN, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Basaran S, Akinci E. Screening autonomic functions in patients with restless legs syndrome: A case-control study in a tertiary care hospital. Auton Neurosci. 2022 Jan;237:102924. doi: 10.1016/j.autneu.2021.102924. Epub 2021 Nov 29.