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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03076541
Other study ID # 1700175
Secondary ID
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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