Cardiovascular Variability, Heart Rate Response, and Electromyogram Power Associated With Periodic Leg Movements.

Completed

• Conditions: Restless Legs Syndrome
• Interventions: Device: standard 24-h ambulatory polysomnography

• Registration Number: NCT03076541
• Lead Sponsor: Centre Hospitalier Universitaire de Saint Etienne

Brief Summary

Periodic leg movements during sleep is associated with microarousals and a stimulation of the sympathetic nervous system. The knowledge of this autonomic activation may help understanding the increase of cardiac risk observed in elderly. The aim of the study is to evaluate the relationship between periodic leg movements severity, age, gender, electromyographic power and heart rate response associated with periodic leg movements. Drug-free patients diagnosed with periodic leg movements were included. Clinical data and 24-h polysomnography recordings were analyzed.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-09-01
• Primary Completion: 2017-03
• Study Completion: 2017-03
• Study First Submitted: 2017-03-06
• Study First Submitted QC: 2017-03-06
• Study First Posted: 2017-03-10
• Status Verified: 2017-07
• Last Update Submitted: 2017-07-04
• Last Update Posted: 2017-07-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• Restless legs syndrome patients
• Hospital routine for periodic leg movements diagnosis
• PLMS index > 0

Exclusion Criteria

• Narcolepsy-cataplexy
• Sleep irregularities and sleep deprivation symptoms
• Lack of neurological or psychiatric diseases
• Upper airway resistance syndrome
• Obstructive sleep apnea
• Treatment, cerebral lesion, medical illness
• Medication or drinks affecting sleep and wake state

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
patients with restless legs syndrome	standard 24-h ambulatory polysomnography	-

Primary Outcome Measures

Name	Time	Method
Amplitude of heart rate response associated with periodic leg movements.	At diagnosis	standard 24-h ambulatory ad libitum polysomnography

Secondary Outcome Measures

Name	Time	Method
Other Heart rate variability indices: Ptot, very-low-frequency (VLF), low frequency (LF), low frequency normalized units (LFnu), high-frequency normalized units (HFnu), LF/HF.	At diagnosis	standard 24-h ambulatory ad libitum polysomnography
electromyography (EMG) power	At diagnosis	standard 24-h ambulatory ad libitum polysomnography

Trial Locations

Locations (1)

Chu Saint-Etienne; 🇫🇷 Saint Etienne, France