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Completed

NCT Number: NCT04906486

Autonomic Assessment in Patients With Restless Legs Syndrome

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.

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Key information

Conditions

Restless Legs Syndrome Autonomic Nervous System Diseases Dyssomnias Mental Disorders Nervous System Diseases Parasomnias Primary Dysautonomias Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Sehnaz Basaran

İzmit, Marmara, 41900, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Scales for Outcomes in Parkinson's disease-Autonomic questionnaire (SCOPA-AUT) (points)

    Time frame: 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.

  2. Age (years)

    Time frame: 6 months

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

  3. Age of disease onset (years)

    Time frame: 6 months

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

  4. Disease duration (years)

    Time frame: 6 months

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

  5. Disease severity (as measured by International Restless Legs Scale) (points)

    Time frame: 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.

  6. Excessive daytime sleepiness (as measured by Epworth Sleepiness scale) (points)

    Time frame: 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.

  7. Body mass index (kg/m2)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Kocaeli Derince Education and Research Hospital

Other

Registry information

Official study title

Clinical Assessment of Autonomic Functions by SCOPA-Autonomic Questionnaire in Patients With Restless Legs Syndrome: A Prospective Study in a Tertiary Care Hospital

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
May 28, 2021
Registry last updated
May 28, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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