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

Stroke Clinical Trial

— SOMN'AIC  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03274505
• Other study ID #: 69HCL17_0418
• Status: Recruiting
• Start date: November 14, 2017
• Est. completion date: August 14, 2023

Study information

• Verified date: November 2021
• Source: Hospices Civils de Lyon
• Contact: Laure PETER-DEREX, MD, PhD
• Phone: 04 72 07 17 69
• Email: laure.peter-derex[@]chu-lyon.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: August 14, 2023
• Est. primary completion date: November 14, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Ischemic Attack, Transient
• Parasomnias
• Sleep Disorder
• Sleep Wake Disorders
• Stroke

Intervention

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)

Locations

Country	Name	City	State
France	Service de Neurologie Vasculaire Groupement Hospitalier Est	Bron
France	Sleep Medicine Center, Croix-Rousse Hospital, Hospices Civils de Lyon	Lyon
France	Service de MPR- Hôpital Henry Gabrielle - Groupement Sud	Saint-Genis-Laval

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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