NCT03076541CompletedNot Applicable
Cardiovascular Variability, Heart Rate Response, and Electromyogram Power Associated With Periodic Leg Movements.
Centre Hospitalier Universitaire de Saint Etienne1 site in 1 country50 target enrollmentStarted: September 1, 2016Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- Amplitude of heart rate response associated with periodic leg movements.
Study Overview
Brief 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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Retrospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Amplitude of heart rate response associated with periodic leg movements.
Time Frame: At diagnosis
standard 24-h ambulatory ad libitum polysomnography
Secondary Outcomes
- 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.(At diagnosis)
- electromyography (EMG) power(At diagnosis)
Investigators
Study Sites (1)
Loading locations...
Similar Trials
Unknown
Not Applicable
Cardiovascular Variability and Heart Rate Response Associated With Obstructive Sleep ApneaSleep Apnea, ObstructiveNCT03075787Centre Hospitalier Universitaire de Saint Etienne60
Completed
Not Applicable
Periodic Limb Movement and Genetic Generalized EpilepsyEpilepsy Generalized Idiopathic Not IntractableNCT03587506University of Alexandria60
Completed
Not Applicable
Sleep stage mediated hemodynamic state modulation reflected by spectral variation of photoplethysmographic pulse volume curvesG47.3Sleep apnoeaDRKS00016123Fachkrankenhaus Kloster Grafschaft GmbH50
Not yet recruiting
Not Applicable
Sleep,hemodynamics and autonomic activations in patients in the cardiovascular care unitJPRN-UMIN000019223Saitama Medical University, International Medical Center50
Completed
Not Applicable
Sleep Quality, Heart Rate Variability and Anxiety Following Brain InjuryTraumatic Brain InjuryAnxietyNCT04652895Shirley Ryan AbilityLab14