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Autonomic Assessment in Patients With Restless Legs Syndrome

NCT ID: NCT04906486

Last Updated: 2021-05-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

155 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-11-12

Study Completion Date

2021-04-12

Brief Summary

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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

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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.

Conditions

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Restless Legs Syndrome

Keywords

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restless legs syndrome autonomic dysfunction dysautonomia SCOPA-AUT questionnaire

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

No interventions assigned to this group

Observational: Healthy controls

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

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Kocaeli Derince Education and Research Hospital

OTHER

Sponsor Role lead

Responsible Party

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Sehnaz Basaran

Principal Investigator, Department of Neurology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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SEHNAZ BASARAN, MD

Role: PRINCIPAL_INVESTIGATOR

KOCAELİ DERİNCE EDUCATION AND RESEARCH HOSPİTAL DEPARTMENT OF NEUROLOGY

Locations

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Sehnaz Basaran

İzmit, Marmara, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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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.

Reference Type DERIVED
PMID: 34871924 (View on PubMed)

Other Identifiers

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2011-KAEK-27/2020-E.2000173683

Identifier Type: -

Identifier Source: org_study_id