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

NCT ID: NCT03076541

Last Updated: 2017-07-06

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

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-09-01

Study Completion Date

2017-03-31

Brief Summary

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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

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Conditions

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Restless Legs Syndrome

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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patients with restless legs syndrome

standard 24-h ambulatory polysomnography

Intervention Type DEVICE

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

Interventions

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standard 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.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Universitaire de Saint Etienne

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Vincent PICHOT, PhD

Role: STUDY_CHAIR

CHU SAINT-ETIENNE

Emilia SFORZA, MD

Role: PRINCIPAL_INVESTIGATOR

CHU SAINT-ETIENNE

Locations

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Chu Saint-Etienne

Saint-Etienne, , France

Site Status

Countries

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France

Other Identifiers

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1700175

Identifier Type: -

Identifier Source: org_study_id

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