Sleep Disorders in Transient Ischemic Attack and Stroke: SOMN'AIC Study

NCT ID: NCT03274505

Last Updated: 2024-07-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

153 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-11-14

Study Completion Date

2022-11-03

Brief Summary

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Sleep disorders in the setting of stroke are numerous, including sleep-related breathing disorders, insomnia, excessive daytime sleepiness and restless legs syndrome. Consequences of theses sleep disturbances include impaired functional outcome and quality of life, anxious and depressive troubles and increased cardio-vascular morbi-mortality. Mechanisms underlying sleep disorders in the setting of stroke are complex and still partly elucidated. They probably involve the consequences of the ischemic lesion and of the handicap, but also of associated vascular risk factors and more generally pre-existent medical history, or they could represent themselves a risk factor for stroke. Transient ischemic attack (TIA) is a particular condition in which risk factors and background of patients are similar to that observed in stroke, without any cerebral lesion and no persistent neurological deficit. The main objective of the SOMN'AIC study is to compare the prevalence of sleep disorders in stroke and in transient ischemic attack (TIA). The study hypothesis is that the prevalence of sleep disorders may be higher in stroke than in TIA patients, reflecting the consequences of the lesion and the associated handicap.

Detailed Description

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Conditions

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Sleep Disorder Stroke

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Stroke patients

Patients seen by a rehabilitation physician at a routine 3 months' post-stroke examination

Questionnaires

Intervention Type OTHER

* Questionnaires about excessive daytime sleepiness (Epworth scale), insomnia (Severity of Insomnia Scale), Restless Legs Syndrome, Chronotype (Horne and Ostberg questionnaire), Sleep apnoea syndrome (Berlin questionnaire)
* Clinical evaluation
* Routine neuropsychological evaluation (for stroke patients)
* Routine Polysomnography for patients with high suspicion of sleep apnoea syndrome (SOS score (Epworth + Berlin) \> 10)

TIA patients

Patients seen by a stroke specialist at the "SOS TIA" examination

Questionnaires

Intervention Type OTHER

* Questionnaires about excessive daytime sleepiness (Epworth scale), insomnia (Severity of Insomnia Scale), Restless Legs Syndrome, Chronotype (Horne and Ostberg questionnaire), Sleep apnoea syndrome (Berlin questionnaire)
* Clinical evaluation
* Routine neuropsychological evaluation (for stroke patients)
* Routine Polysomnography for patients with high suspicion of sleep apnoea syndrome (SOS score (Epworth + Berlin) \> 10)

Interventions

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Questionnaires

* Questionnaires about excessive daytime sleepiness (Epworth scale), insomnia (Severity of Insomnia Scale), Restless Legs Syndrome, Chronotype (Horne and Ostberg questionnaire), Sleep apnoea syndrome (Berlin questionnaire)
* Clinical evaluation
* Routine neuropsychological evaluation (for stroke patients)
* Routine Polysomnography for patients with high suspicion of sleep apnoea syndrome (SOS score (Epworth + Berlin) \> 10)

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Stroke group: patients with a diagnosis of stoke and seen at the routine post-stroke 3 month' rehabilitation examination
* TIA group: diagnosis of a TIA by a stroke specialist at the "SOS TIA" examination
* \> 18 years

Exclusion Criteria

* Refusal to participate
* Severe cognitive impairment leading to inability to fulfil questionnaires
* For the TIA group: presence of an ischemic lesion on CT scan or MRI
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospices Civils de Lyon

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Laure PETER-DEREX, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Centre de Médecine du Sommeil et des Maladies respiratoires, CH de la Croix Rousse - HCL

Locations

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Service de Neurologie Vasculaire Groupement Hospitalier Est

Bron, , France

Site Status

Sleep Medicine Center, Croix-Rousse Hospital, Hospices Civils de Lyon

Lyon, , France

Site Status

Service de MPR- Hôpital Henry Gabrielle - Groupement Sud

Saint-Genis-Laval, , France

Site Status

Countries

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France

Other Identifiers

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69HCL17_0418

Identifier Type: -

Identifier Source: org_study_id

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