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

Restless Legs Syndrome Clinical Trial

— PLMS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03076541
• Other study ID #: 1700175
• Status: Completed
• Phase: N/A
• First received: March 6, 2017
• Last updated: July 4, 2017
• Start date: September 1, 2016
• Est. completion date: March 2017

Study information

• Verified date: July 2017
• Source: Centre Hospitalier Universitaire de Saint Etienne
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: March 2017
• Est. primary completion date: March 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Psychomotor Agitation
• Restless Legs Syndrome

Intervention

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.

Locations

Country	Name	City	State
France	Chu Saint-Etienne	Saint Etienne

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Saint Etienne

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Amplitude of heart rate response associated with periodic leg movements.	standard 24-h ambulatory ad libitum polysomnography	At diagnosis
Secondary	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	At diagnosis
Secondary	electromyography (EMG) power	standard 24-h ambulatory ad libitum polysomnography	At diagnosis