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CompletedNCT03076541PLMSUpdated Jul 6, 2017

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

An observational study in Restless Legs Syndrome, sponsored by Centre Hospitalier Universitaire de Saint Etienne. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-07-06.

Sponsored by Centre Hospitalier Universitaire de Saint Etienne · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
50
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Restless Legs Syndrome

Keywords

  • Restless legs syndrome
  • Periodic leg movements
  • Heart rate
  • Heart rate variability
  • Microarousals
  • Autonomic nervous system activity
03

In context

Psychomotor Agitation

500 studies on the registry are indexed under Psychomotor Agitation; 55 are open to participants now.

This study's enrollment of 50 is below the median of 154 across 71 observational studies indexed under Psychomotor Agitation.

Browse Psychomotor Agitation studies →

Lead sponsor

Centre Hospitalier Universitaire de Saint Etienne is the lead sponsor of 578 studies on the registry; 128 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
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.

Inclusion criteria

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

Exclusion criteria

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
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Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
50 participants (actual)
Patient registry
No

Groups and cohorts

  • patients with restless legs syndrome

    Device: standard 24-h ambulatory polysomnography

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.

06

What researchers measure

Primary outcomes

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

    standard 24-h ambulatory ad libitum polysomnography

    Time frame: At diagnosis

Secondary outcomes

  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.

    standard 24-h ambulatory ad libitum polysomnography

    Time frame: At diagnosis

  2. electromyography (EMG) power

    standard 24-h ambulatory ad libitum polysomnography

    Time frame: At diagnosis

07

Study locations

1 site
  • Chu Saint-Etienne
    Saint Etienne, 42055, France
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 6, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03076541
Lead sponsor
Centre Hospitalier Universitaire de Saint Etienne
Responsible party
Sponsor
First posted
Mar 10, 2017
Start date
Sep 1, 2016
Primary completion
Mar 2017
Completion
Mar 2017
Last update
Jul 6, 2017

Study contacts

Vincent PICHOT, PhD
study chair · CHU SAINT-ETIENNE
Emilia SFORZA, MD
principal investigator · CHU SAINT-ETIENNE

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2017. You cannot join it, but the record below documents what was studied.

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