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

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Chu Saint-Etienne

Saint-Etienne, 42055, France

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

standard 24-h ambulatory polysomnography

Device

A standard 24-h ambulatory ad libitum polysomnography including EEG, electro-oculography (EOG), electromyography (EMG), EKG, was performed by a standard clinical.

Primary outcomes

Amplitude of heart rate response associated with periodic leg movements.

Time frame: At diagnosis

standard 24-h ambulatory ad libitum polysomnography

Secondary outcomes

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.

Time frame: At diagnosis

standard 24-h ambulatory ad libitum polysomnography
electromyography (EMG) power

Time frame: At diagnosis

standard 24-h ambulatory ad libitum polysomnography

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Saint Etienne

Other

Registry information

Acronym: PLMS

Important dates

Study start: 2016
Primary completion: 2017
Study completion: 2017
First posted: Mar 10, 2017
Registry last updated: Jul 6, 2017

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.

Published trials that share one or more normalized conditions with this study.

Completed