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

C

Centre Hospitalier Universitaire de Saint Etienne

Status

Completed

Conditions

Restless Legs Syndrome

Treatments

Device: standard 24-h ambulatory polysomnography

Study type

Observational

Funder types

Other

Identifiers

NCT03076541
1700175

Details and patient eligibility

About

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.

Enrollment

50 patients

Sex

All

Ages

18+ years old

Volunteers

No 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

Trial design

50 participants in 1 patient group

patients with restless legs syndrome
Treatment:
Device: standard 24-h ambulatory polysomnography

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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