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

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ClinicalTrials.gov Identifier: NCT03076541
Recruitment Status : Completed
First Posted : March 10, 2017
Last Update Posted : July 6, 2017
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Restless Legs Syndrome Device: standard 24-h ambulatory polysomnography

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Study Type : Observational
Actual Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Cardiovascular Variability, Heart Rate Response, and Electromyogram Power Associated With Periodic Leg Movements.
Actual Study Start Date : September 1, 2016
Actual Primary Completion Date : March 2017
Actual Study Completion Date : March 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Restless Legs

Group/Cohort Intervention/treatment
patients with restless legs syndrome Device: 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.




Primary Outcome Measures :
  1. Amplitude of heart rate response associated with periodic leg movements. [ Time Frame: At diagnosis ]
    standard 24-h ambulatory ad libitum polysomnography


Secondary Outcome Measures :
  1. 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

  2. electromyography (EMG) power [ Time Frame: At diagnosis ]
    standard 24-h ambulatory ad libitum polysomnography



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
patients with restless legs syndrome with a diagnosis from January 1rst 2012 to september 1rst 2016.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03076541


Locations
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France
Chu Saint-Etienne
Saint Etienne, France, 42055
Sponsors and Collaborators
Centre Hospitalier Universitaire de Saint Etienne
Investigators
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Study Chair: Vincent PICHOT, PhD CHU SAINT-ETIENNE
Principal Investigator: Emilia SFORZA, MD CHU SAINT-ETIENNE

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Responsible Party: Centre Hospitalier Universitaire de Saint Etienne
ClinicalTrials.gov Identifier: NCT03076541     History of Changes
Other Study ID Numbers: 1700175
First Posted: March 10, 2017    Key Record Dates
Last Update Posted: July 6, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Centre Hospitalier Universitaire de Saint Etienne:
Restless legs syndrome
Periodic leg movements
Heart rate
Heart rate variability
Microarousals
Autonomic nervous system activity
Additional relevant MeSH terms:
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Psychomotor Agitation
Restless Legs Syndrome
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Psychomotor Disorders
Neurobehavioral Manifestations
Signs and Symptoms
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Parasomnias
Mental Disorders