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

Ischemic Stroke Clinical Trial

— PSG-AVC  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04816136
• Other study ID #: RECHMPL20_0120
• Status: Completed
• Start date: January 1, 2002
• Est. completion date: March 1, 2021

Study information

• Verified date: March 2021
• Source: University Hospital, Montpellier
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 227
• Est. completion date: March 1, 2021
• Est. primary completion date: April 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Cerebral Infarct
• Cerebral Infarction
• Infarction
• Ischemia
• Ischemic Stroke
• Movement Disorders
• Nocturnal Myoclonus Syndrome
• Periodic Limb Movement Disorder
• Sleep Apnea
• Stroke

Intervention

Other:
• Sleep recording (already done)
Sleep recording (already done)

Locations

Country	Name	City	State
France	Uhmontpellier	Montpellier

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Montpellier

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Correlation between polysomnographic abnormalities and functional recovery	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	functional recovery at 6 months
Secondary	Correlation between polysomnographic abnormalities and survival, onset of new cardio vascular events, functionnal recovery and quality of life.	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.	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