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Clinical Trials/NCT03274505
NCT03274505CompletedNot Applicable

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

Hospices Civils de Lyon3 sites in 1 country153 target enrollmentStarted: November 14, 2017Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
153
Locations
3
Primary Endpoint
Comparison of stroke and transient ischemic attack population regarding the prevalence of the presence of at least one sleep disorder

Study Overview

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.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Cross Sectional

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Outcomes

Primary Outcomes

Comparison of stroke and transient ischemic attack population regarding the prevalence of the presence of at least one sleep disorder

Time Frame: 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)

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (3)

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