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

NCT03274505 | Completed

• 1 other identifier: 69HCL17_0418
• Study Type: observational
• Target: 153
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

Sleep Disorder; Stroke

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Stroke patients

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

Other: Questionnaires

TIA patients

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

Other: Questionnaires

Interventions

Questionnaires 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)

Stroke patients; TIA patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Stroke and transient ischemic attack patients

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (3)

Service de Neurologie Vasculaire Groupement Hospitalier Est

Bron, 69477, France

Location

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

Lyon, 69004, France

Location

Service de MPR- Hôpital Henry Gabrielle - Groupement Sud

Saint-Genis-Laval, 69230, France

Location

MeSH Terms

Conditions

Sleep Wake Disorders; Stroke

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Laure PETER-DEREX, MD, PhD

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 5, 2017
• First Posted: September 7, 2017
• Study Start: November 14, 2017
• Primary Completion: June 11, 2022
• Study Completion: November 3, 2022
• Last Updated: July 23, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

FR (3)