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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03274505
Acronym
SOMN'AIC
Enrollment
153
Registered
2017-09-07
Start date
2017-11-14
Completion date
2022-11-03
Last updated
2024-07-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sleep Disorder, Stroke

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.

Interventions

OTHERQuestionnaires

* 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)

Sponsors

Hospices Civils de Lyon
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

Design outcomes

Primary

MeasureTime frameDescription
Comparison of stroke and transient ischemic attack population regarding the prevalence of the presence of at least one sleep disorderMaximum 9 monthsPresence 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)

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026