Autonomic Assessment in Patients With Restless Legs Syndrome

Restless Legs Syndrome Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04906486
• Other study ID #: 2011-KAEK-27/2020-E.2000173683
• Status: Completed
• Start date: November 12, 2020
• Est. completion date: April 12, 2021

Study information

• Verified date: May 2021
• Source: Kocaeli Derince Education and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 155
• Est. completion date: April 12, 2021
• Est. primary completion date: April 10, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Psychomotor Agitation
• Restless Legs Syndrome
• Syndrome

Locations

Country	Name	City	State
Turkey	Sehnaz Basaran	I?zmi?t	Marmara
Turkey	Sehnaz Basaran	Izmit	Marmara

Sponsors (1)

Lead Sponsor	Collaborator
Kocaeli Derince Education and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Scales for Outcomes in Parkinson's disease-Autonomic questionnaire (SCOPA-AUT) (points)	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.	6 months
Primary	Age (years)	Correlation between autonomic dysfunction and age (years) in patients with restless legs syndrome noted.	6 months
Primary	Age of disease onset (years)	Correlation between autonomic dysfunction and age of disease onset (years) in patients with restless legs syndrome noted.	6 months
Primary	Disease duration (years)	Correlation between autonomic dysfunction and disease duration (years) in patients with restless legs syndrome noted.	6 months
Primary	Disease severity (as measured by International Restless Legs Scale) (points)	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.	6 months
Primary	Excessive daytime sleepiness (as measured by Epworth Sleepiness scale) (points)	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.	6 months
Primary	Body mass index (kg/m2)	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.	6 months