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Consequences of Post Stroke Polysomnographic Abnormalities on Functionnal Recovery and Survival After an Ischemic Stroke (PSG-AVC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04816136
Recruitment Status : Completed
First Posted : March 25, 2021
Last Update Posted : March 25, 2021
Sponsor:
Information provided by (Responsible Party):
University Hospital, Montpellier

Study Description
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Brief Summary:

Ischemic stroke is a major public health issue, likely to cause functional disability. It is well known that sleep has an impact on brain plasticity, and after an ischemic stroke, studies have shown subjective sleep quality alterations and sleep architecture abnormalities.

Furthermore, there is no clear guideline showing the usefulness of a systematic sleep investigation following an ischemic stroke.

The aim of the study is to identify retrospectively correlation between polysomnographic abnormalities (sleep apnea, periodic limb movements, disturbed sleep architecture…) and functional recovery after an ischemic stroke. The study also assesses the impact of sleep abnormalities on survival, and the risk of new cardiovascular event.


Condition or disease Intervention/treatment
Ischemic Stroke Cerebral Infarct Sleep Apnea Periodic Limb Movement Disorder Other: Sleep recording (already done)

Detailed Description:
This study is a retrospective observational study, from a cohort of patients who had a sleep recording (polysomnography or ventilatory polygraphy performed in Montpellier University Hospital) following an ischemic stroke.
Study Design
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Study Type : Observational
Actual Enrollment : 227 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Consequences of Post Stroke Polysomnographic Abnormalities on Functionnal Recovery and Survival After an Ischemic Stroke
Actual Study Start Date : January 1, 2002
Actual Primary Completion Date : April 1, 2020
Actual Study Completion Date : March 1, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ischemic Stroke

Groups and Cohorts
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Group/Cohort Intervention/treatment
patients with a sleep recording performed
patients with a sleep recording performed in the sleep unit in Montpellier University Hospital, who had an ischemic stroke before the recording.
 Other: Sleep recording (already done)
Sleep recording (already done)


Outcome Measures
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Primary Outcome Measures :
  1. Correlation between polysomnographic abnormalities and functional recovery [ Time Frame: functional recovery at 6 months ]
    polysomnographic abnormalities : sleep apnea, periodic limb movements, distribution of sleep stage / functional recovery : modified rankin score and National Institutes of Health Stroke Scale at 6 months


Secondary Outcome Measures :
  1. Correlation between polysomnographic abnormalities and survival, onset of new cardio vascular events, functionnal recovery and quality of life. [ Time Frame: survival or onset of new cardio vascular events at one year, quality of life evaluated by self questionnaire at one year and functionnal recovery (modified rankin score and National Institutes of Health Stroke Scale) at one year ]
    polysomnographic abnormalities : sleep apnea, periodic limb movements, distribution of sleep stage / survival or onset of cardio vascular events, quality of life (SF 36), modified rankin score and National Institutes of Health Stroke Scale at one year.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients selected with computer codes of disease and examination corresponding to the criteria : sleep recording and ischemic stroke
Criteria

Inclusion criteria:

  • men and women, more than 18 years old
  • medical history of ischemic stroke
  • who had a sleep recording following the stroke

Exclusion criteria:

  • others types of strokes (bleeding, transient ischemic attack, cerebal veinous thrombosis)
  • patients less than 18 years old
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04816136


Locations
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France
Uhmontpellier
Montpellier, France, 34295
Sponsors and Collaborators
University Hospital, Montpellier
Investigators
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Study Director: Yves DAUVILLIERS, MD PhD University Hospital, Montpellier
More Information
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: University Hospital, Montpellier
ClinicalTrials.gov Identifier: NCT04816136    
Other Study ID Numbers: RECHMPL20_0120
First Posted: March 25, 2021    Key Record Dates
Last Update Posted: March 25, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: NC

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Montpellier:
Functional recovery
Ischemic stroke / cerebral infarct
Sleep
Polysomnography
Additional relevant MeSH terms:
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Stroke
Ischemic Stroke
Cerebral Infarction
Movement Disorders
Nocturnal Myoclonus Syndrome
Ischemia
Infarction
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
 Vascular Diseases
Cardiovascular Diseases
Pathologic Processes
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Brain Infarction
Brain Ischemia
Necrosis
Parasomnias