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

Completed

• Conditions: Cerebral Infarct; Sleep Apnea; Periodic Limb Movement Disorder; Ischemic Stroke
• Interventions: Other: Sleep recording (already done)

• Registration Number: NCT04816136
• Lead Sponsor: University Hospital, Montpellier

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.

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 Timeline

• Study Start: 2002-01-01
• Primary Completion: 2020-04-01
• Status Verified: 2021-03
• Study Completion: 2021-03-01
• Study First Submitted: 2021-03-19
• Study First Submitted QC: 2021-03-24
• Last Update Submitted: 2021-03-24
• Study First Posted: 2021-03-25
• Last Update Posted: 2021-03-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 227

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
patients with a sleep recording performed	Sleep recording (already done)	patients with a sleep recording performed in the sleep unit in Montpellier University Hospital, who had an ischemic stroke before the recording.

Primary Outcome Measures

Name	Time	Method
Correlation between polysomnographic abnormalities and functional recovery	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

Name	Time	Method
Correlation between polysomnographic abnormalities and survival, onset of new cardio vascular events, functionnal recovery and quality of life.	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.

Trial Locations

Locations (1)

Uhmontpellier; 🇫🇷 Montpellier, France