NCT04816136

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
227

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2002

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2002

Completed
18.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2020

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2021

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

March 19, 2021

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 25, 2021

Completed
Last Updated

March 25, 2021

Status Verified

March 1, 2021

Enrollment Period

18.3 years

First QC Date

March 19, 2021

Last Update Submit

March 24, 2021

Conditions

Ischemic StrokeCerebral InfarctSleep ApneaPeriodic Limb Movement Disorder

Keywords

Functional recoveryIschemic stroke / cerebral infarctSleepPolysomnography

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • 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

Study Arms (1)

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)

Interventions

Sleep recording (already done)OTHER

Sleep recording (already done)

patients with a sleep recording performed

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients selected with computer codes of disease and examination corresponding to the criteria : sleep recording and ischemic stroke

You may qualify if:

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

You may not qualify if:

  • others types of strokes (bleeding, transient ischemic attack, cerebal veinous thrombosis)
  • patients less than 18 years old

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Uhmontpellier

Montpellier, 34295, France

Location

MeSH Terms

Conditions

Ischemic StrokeCerebral InfarctionSleep Apnea SyndromesNocturnal Myoclonus Syndrome

Condition Hierarchy (Ancestors)

StrokeCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesBrain InfarctionBrain IschemiaInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosisApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersParasomnias

Study Officials

  • Yves DAUVILLIERS, MD PhD

    University Hospital, Montpellier

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 19, 2021

First Posted

March 25, 2021

Study Start

January 1, 2002

Primary Completion

April 1, 2020

Study Completion

March 1, 2021

Last Updated

March 25, 2021

Record last verified: 2021-03

Locations

FR(1)