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

Comparison of the Prevalence of Sleep Disorders in Transient Ischemic Attack and Stroke

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.

Study Overview

• Status: Recruiting
• Conditions: Stroke; Sleep Disorder
• Intervention / Treatment: Other: Questionnaires

• Study Type: Observational
• Enrollment (Anticipated): 200

Contacts and Locations

• Study Contact: Name: Laure PETER-DEREX, MD, PhD; Phone Number: +33 04 72 07 17 69; Email: laure.peter-derex@chu-lyon.fr

Study Locations

• France
  • Bron, France, 69477
    • Recruiting
    • Service de Neurologie Vasculaire Groupement Hospitalier Est
    • Sub-Investigator: Laurent Derex, PH
    • Sub-Investigator: Elodie Ong, PH
  • Lyon, France, 69004
    • Active, not recruiting
    • Sleep Medicine Center, Croix-Rousse Hospital, Hospices Civils de Lyon
  • Saint-Genis-Laval, France, 69230
    • Recruiting
    • Service de MPR- Hôpital Henry Gabrielle - Groupement Sud
    • Sub-Investigator: Jacques Luauté, PU-PH
    • Sub-Investigator: Sophie Jacquin Courtois, PU-PH
    • Sub-Investigator: Maxime Cheminon, PH
    • Sub-Investigator: Laure HUCHON, PH

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Stroke and transient ischemic attack patients

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Stroke patients; Patients seen by a rehabilitation physician at a routine 3 months' post-stroke examination	Other: 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)
TIA patients; Patients seen by a stroke specialist at the "SOS TIA" examination	Other: 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comparison of stroke and transient ischemic attack population regarding the prevalence of the presence of at least one sleep disorder	Presence of at least one of the following sleep disorders assessed by clinical evaluation, questionnaires +/- polysomnography: insomnia, excessive daytime sleepiness (EDS), restless legs syndrome (RLS) and sleep apnoea syndrome (SAS)	Maximum 9 months

Collaborators and Investigators

• Sponsor: Hospices Civils de Lyon

Study record dates

Study Major Dates

• Study Start (Actual): November 14, 2017
• Primary Completion (Anticipated): November 14, 2022
• Study Completion (Anticipated): August 14, 2023

Study Registration Dates

• First Submitted: September 5, 2017
• First Submitted That Met QC Criteria: September 5, 2017
• First Posted (Actual): September 7, 2017

Study Record Updates

• Last Update Posted (Actual): November 16, 2021
• Last Update Submitted That Met QC Criteria: November 15, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Brain Ischemia; Stroke; Sleep Wake Disorders; Ischemic Attack, Transient; Parasomnias
• Other Study ID Numbers: 69HCL17_0418

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No