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OpenTrials
Completed

NCT Number: NCT04816136

Consequences of Post Stroke Polysomnographic Abnormalities on Functionnal Recovery and Survival After an Ischemic Stroke

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sleep recording (already done)

Other

Sleep recording (already done)

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

University Hospital, Montpellier

Other

Registry information

Acronym: PSG-AVC

Important dates

Study start
2002
Primary completion
2020
Study completion
2021
First posted
Mar 25, 2021
Registry last updated
Mar 25, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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