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

NCT03076541 | Completed

• 1 other identifier: 1700175
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Restless Legs Syndrome

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Amplitude of heart rate response associated with periodic leg movements.

  standard 24-h ambulatory ad libitum polysomnography

  At diagnosis

Secondary Outcomes (2)

• 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

• electromyography (EMG) power

  At diagnosis

Study Arms (1)

patients with restless legs syndrome

Device: standard 24-h ambulatory polysomnography

Interventions

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.

patients with restless legs syndrome

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

patients with restless legs syndrome with a diagnosis from January 1rst 2012 to september 1rst 2016.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Saint Etienne: lead

Study Sites (1)

Chu Saint-Etienne

Saint-Etienne, 42055, France

Location

MeSH Terms

Conditions

Restless Legs Syndrome

Condition Hierarchy (Ancestors)

Nervous System Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Parasomnias; Mental Disorders

Study Officials

• Vincent PICHOT, PhD

  CHU SAINT-ETIENNE

  STUDY CHAIR

• Emilia SFORZA, MD

  CHU SAINT-ETIENNE

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 6, 2017
• First Posted: March 10, 2017
• Study Start: September 1, 2016
• Primary Completion: March 1, 2017
• Study Completion: March 1, 2017
• Last Updated: July 6, 2017

Record last verified: 2017-07

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)