NCT04906486

Autonomic Assessment in Patients With Restless Legs Syndrome

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 155 (actual)
• Sponsor: Kocaeli Derince Education and Research Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• Restless Legs Syndrome

Timeline

• Start date: 2020-11-12
• Primary completion: 2021-04-10
• Completion: 2021-04-12
• First posted: 2021-05-28
• Last updated: 2021-05-28

Locations

1 site across 1 country: Turkey (Türkiye)