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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03076541

Acronym

PLMS

Enrollment

Registered

2017-03-10

Start date

2016-09-01

Completion date

2017-03-31

Last updated

2017-07-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Restless Legs Syndrome

Keywords

Restless legs syndrome, Periodic leg movements, Heart rate, Heart rate variability, Microarousals, Autonomic nervous system activity

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.

Interventions

DEVICEstandard 24-h ambulatory polysomnography

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

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
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

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026