Restless Legs Syndrome Clinical Trial
— PLMSOfficial title:
Cardiovascular Variability, Heart Rate Response, and Electromyogram Power Associated With Periodic Leg Movements.
Verified date | July 2017 |
Source | Centre Hospitalier Universitaire de Saint Etienne |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
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 |
Country | Name | City | State |
---|---|---|---|
France | Chu Saint-Etienne | Saint Etienne |
Lead Sponsor | Collaborator |
---|---|
Centre Hospitalier Universitaire de Saint Etienne |
France,
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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