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

Completed

• Conditions: Sleep Disorder; Stroke
• Interventions: Other: Questionnaires

• Registration Number: NCT03274505
• Lead Sponsor: Hospices Civils de Lyon

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-09-05
• Study First Submitted QC: 2017-09-05
• Study First Posted: 2017-09-07
• Study Start: 2017-11-14
• Primary Completion: 2022-06-11
• Study Completion: 2022-11-03
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-22
• Last Update Posted: 2024-07-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 153

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
TIA patients	Questionnaires	Patients seen by a stroke specialist at the "SOS TIA" examination
Stroke patients	Questionnaires	Patients seen by a rehabilitation physician at a routine 3 months' post-stroke examination

Primary Outcome Measures

Name	Time	Method
Comparison of stroke and transient ischemic attack population regarding the prevalence of the presence of at least one sleep disorder	Maximum 9 months	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)

Trial Locations

Locations (3)

Service de Neurologie Vasculaire Groupement Hospitalier Est; 🇫🇷 Bron, France

Service de MPR- Hôpital Henry Gabrielle - Groupement Sud; 🇫🇷 Saint-Genis-Laval, France

Sleep Medicine Center, Croix-Rousse Hospital, Hospices Civils de Lyon; 🇫🇷 Lyon, France