- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01967303
Restless Legs Syndrome in Stroke Patients
October 17, 2013 updated by: Dr. Ilana Schlesinger, Rambam Health Care Campus
Our study aimed to examine a possible association between Restless legs syndrome and cerebrovascular disease, by examining patients during hospitalization for acute stroke or transient ischemic attack, in a matched case-control design.
Study Overview
Status
Completed
Study Type
Observational
Enrollment (Actual)
447
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
Probability Sample
Study Population
Patients hospitalized with stroke or transient ischemic attack.
Description
Inclusion Criteria:
- 18 years old or older
- Hospitalization for stroke or transient ischemic attack
Exclusion Criteria:
- 18 years old or younger
- No stroke or transient ischemic attack
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 |
---|
Patients with stroke or transient ischemic attack
Interview regarding restless legs syndrome
|
Subjects without stroke or transient ischemic attack
Interview regarding restless legs syndrome
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Prevalence of Restless legs syndrome in patients with stroke or Transient ischemic attack vs. prevalence in controls.
Time Frame: At time of interview
|
The frequency (prevalence) of restless leg syndrome (RLS) in patients who have suffered stroke or TIA will be compared to that of subjects who have not suffered stroke or TIA (controls).
The two groups will be stratified with regard to age and gender.
Statistical comparison will be made by univariate analyses and by multivariate logistic regression analyses (which will include cerebrovascular risk factors besides stroke or TIA).
|
At time of interview
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Ilana Schlesinger, Rambam Health Care Campus, Haifa, Israel
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
January 1, 2008
Primary Completion (Actual)
December 1, 2008
Study Completion (Actual)
December 1, 2008
Study Registration Dates
First Submitted
September 15, 2013
First Submitted That Met QC Criteria
October 17, 2013
First Posted (Estimate)
October 22, 2013
Study Record Updates
Last Update Posted (Estimate)
October 22, 2013
Last Update Submitted That Met QC Criteria
October 17, 2013
Last Verified
October 1, 2013
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Mental Disorders
- Pathologic Processes
- Cardiovascular Diseases
- Vascular Diseases
- Cerebrovascular Disorders
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Sleep Disorders, Intrinsic
- Dyssomnias
- Sleep Wake Disorders
- Neurologic Manifestations
- Neurobehavioral Manifestations
- Disease
- Dyskinesias
- Psychomotor Disorders
- Parasomnias
- Brain Ischemia
- Stroke
- Syndrome
- Psychomotor Agitation
- Restless Legs Syndrome
- Ischemic Attack, Transient
Other Study ID Numbers
- 3186
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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