Restless Legs SyndromeNCT01967303
Restless Legs Syndrome in Stroke Patients
An observational study of Restless Legs Syndrome and Stroke, run by Rambam Health Care Campus.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Restless Legs Syndrome, Stroke, Transient Ischemic Attack
- How many people
- 447 participants
- Where
- No sites listed yet
- Study dates
- Jan 2008to Dec 2008
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients hospitalized with stroke or transient ischemic attack.
Who may be able to join
- 18 years old or older
- Hospitalization for stroke or transient ischemic attack
Who cannot join
- 18 years old or younger
- No stroke or transient ischemic attack
About this study
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.
- Conditions
- Restless Legs Syndrome, Stroke, Transient Ischemic Attack
- Keywords
- Restless legs syndrome, Stroke, Transient ischemic attack, Cerebrovascular risk factors
- Medical subject headings
- Restless Legs Syndrome, Stroke, Ischemic Attack, Transient
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of Restless legs syndrome in patients with stroke or Transient ischemic attack vs. prevalence in controls.
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).
Measured: At time of interview
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2013 (estimated)
- Study startJan 2008
- Primary completionDec 2008
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Restless Legs SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 447 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rambam Health Care Campus
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Ilana Schlesinger, Rambam Health Care Campus
- Investigators
- Ilana Schlesinger, Principal investigator, Rambam Health Care Campus, Haifa, Israel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01967303
- Sponsor's protocol ID
- 3186
- Status last verified
- Oct 2013
- First submitted
- 15 Sep 2013
- Last updated
- 22 Oct 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Restless Legs Syndrome in Stroke Patients
- ClinicalTrials.gov ID
- NCT01967303
- Acronym / sponsor ID
- 3186
- Conditions
- Restless Legs Syndrome, Stroke, Transient Ischemic Attack
- Keywords
- Restless legs syndrome, Stroke, Transient ischemic attack, Cerebrovascular risk factors
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 447 participants (actual)
- Lead sponsor
- Rambam Health Care CampusUniversity, hospital or other
- Study start
- Jan 2008
- Primary completion
- Dec 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 22 Oct 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with stroke or transient ischemic attack | – | –Interview regarding restless legs syndrome |
| Subjects without stroke or transient ischemic attack | – | –Interview regarding restless legs syndrome |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients hospitalized with stroke or transient ischemic attack.
Key inclusion criteria (2 listed)
- 18 years old or older
- Hospitalization for stroke or transient ischemic attack
Key exclusion criteria (2 listed)
- 18 years old or younger
- No stroke or transient ischemic attack
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ilana Schlesinger principal investigator
Rambam Health Care Campus, Haifa, Israel
Questions about this trial
What is this clinical trial studying?
An observational study of Restless Legs Syndrome and Stroke, run by Rambam Health Care Campus.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Oct 2013. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of Restless legs syndrome in patients with stroke or Transient ischemic attack vs. prevalence in controls. (time frame: At time of interview). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2013.