- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03076541
Cardiovascular Variability, Heart Rate Response, and Electromyogram Power Associated With Periodic Leg Movements. (PLMS)
July 4, 2017 updated by: Centre Hospitalier Universitaire de Saint Etienne
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 Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
50
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Saint Etienne, France, 42055
- CHU Saint-Etienne
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
patients with restless legs syndrome with a diagnosis from January 1rst 2012 to september 1rst 2016.
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
patients with restless legs syndrome
|
A standard 24-h ambulatory ad libitum polysomnography including EEG, electro-oculography (EOG), electromyography (EMG), EKG, was performed by a standard clinical.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Amplitude of heart rate response associated with periodic leg movements.
Time Frame: At diagnosis
|
standard 24-h ambulatory ad libitum polysomnography
|
At diagnosis
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
Time Frame: At diagnosis
|
standard 24-h ambulatory ad libitum polysomnography
|
At diagnosis
|
electromyography (EMG) power
Time Frame: At diagnosis
|
standard 24-h ambulatory ad libitum polysomnography
|
At diagnosis
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Chair: Vincent PICHOT, PhD, CHU Saint-Etienne
- Principal Investigator: Emilia SFORZA, MD, CHU Saint-Etienne
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 1, 2016
Primary Completion (Actual)
March 1, 2017
Study Completion (Actual)
March 1, 2017
Study Registration Dates
First Submitted
March 6, 2017
First Submitted That Met QC Criteria
March 6, 2017
First Posted (Actual)
March 10, 2017
Study Record Updates
Last Update Posted (Actual)
July 6, 2017
Last Update Submitted That Met QC Criteria
July 4, 2017
Last Verified
July 1, 2017
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1700175
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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