Clinical Assessment of Autonomic Functions by SCOPA-Autonomic Questionnaire in Patients With Restless Legs Syndrome: A Prospective Study in a Tertiary Care Hospital
Sponsor study identifier
observational
155
1 country
1
Study Start
November 12, 2020
Actual (reported)Primary Completion
April 10, 2021
Actual (reported)Study Completion
April 12, 2021
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
April 12, 2021
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
November 12, 2020
Actual (reported)April 10, 2021
Actual (reported)April 12, 2021
Actual (reported)May 22, 2021
Actual (reported)May 28, 2021
Actual (reported)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.
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.
The control group consisted of 85 age- and gender-matched healthy volunteers.
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.
Sehnaz Basaran
İzmit, Marmara, 41900, Turkey (Türkiye)
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.
SEHNAZ BASARAN, MD
KOCAELİ DERİNCE EDUCATION AND RESEARCH HOSPİTAL DEPARTMENT OF NEUROLOGY
155 participants (actual enrollment reported by the registry).
First Submitted
May 22, 2021
First Posted
May 28, 2021
Study Start
November 12, 2020
Actual (reported)REST Study (CompRESsion Therapy for RLS)
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
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Primary Completion
April 10, 2021
Actual (reported)Study Completion
April 12, 2021
Actual (reported)Last Updated
May 28, 2021
Record last verified: 2021-05
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