Autonomic Assessment in Patients With Restless Legs Syndrome

NCT04906486 | Completed

• 1 other identifier: 2011-KAEK-27/2020-E.2000173683
• Study Type: observational
• Target: 155
• Locations: 1 country
• Sites: 1

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.

Conditions

Restless Legs Syndrome

Keywords

restless legs syndrome; autonomic dysfunction; dysautonomia; SCOPA-AUT questionnaire

Outcome Measures

Primary Outcomes (7)

• 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

• Age (years)

  Correlation between autonomic dysfunction and age (years) in patients with restless legs syndrome noted.

  6 months

• Age of disease onset (years)

  Correlation between autonomic dysfunction and age of disease onset (years) in patients with restless legs syndrome noted.

  6 months

• Disease duration (years)

  Correlation between autonomic dysfunction and disease duration (years) in patients with restless legs syndrome noted.

  6 months

• 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

• 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

• 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

Study Arms (2)

Observational: Patients with restless legs syndrome

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

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

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Kocaeli Derince Education and Research Hospital: lead

Study Sites (1)

Sehnaz Basaran

İzmit, Marmara, 41900, Turkey (Türkiye)

Location

Related Publications (1)

• 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.

  PMID: 34871924 DERIVED

MeSH Terms

Conditions

Restless Legs Syndrome; Primary Dysautonomias; Autonomic Nervous System Diseases

Condition Hierarchy (Ancestors)

Nervous System Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Parasomnias; Mental Disorders

Study Officials

• SEHNAZ BASARAN, MD

  KOCAELİ DERİNCE EDUCATION AND RESEARCH HOSPİTAL DEPARTMENT OF NEUROLOGY

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Department of Neurology

Study Record Dates

• First Submitted: May 22, 2021
• First Posted: May 28, 2021
• Study Start: November 12, 2020
• Primary Completion: April 10, 2021
• Study Completion: April 12, 2021
• Last Updated: May 28, 2021

Record last verified: 2021-05

Locations

TU (1)