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CompletedNCT03274505SOMN'AICUpdated Jul 23, 2024

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

An observational study in Sleep Disorder and Stroke, sponsored by Hospices Civils de Lyon. Completed at 3 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-07-23.

Sponsored by Hospices Civils de Lyon · Observational

Study type
Observational
Model
Cohort
Time perspective
Cross-sectional
Enrollment
153
Ages
18 Years and older
Sex
All
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Study 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.

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Conditions studied

  • Sleep Disorder
  • Stroke
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In context

Sleep Wake Disorders

804 studies on the registry are indexed under Sleep Wake Disorders; 188 are open to participants now.

This study's enrollment of 153 is above the median of 114 across 223 observational studies indexed under Sleep Wake Disorders.

Browse Sleep Wake Disorders studies →

Lead sponsor

Hospices Civils de Lyon is the lead sponsor of 1,856 studies on the registry; 442 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Stroke and transient ischemic attack patients

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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

Observational model
Cohort
Time perspective
Cross-sectional
Enrollment
153 participants (actual)
Patient registry
No

Groups and cohorts

  • 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

  • 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)

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What researchers measure

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)

    Time frame: Maximum 9 months

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Study locations

3 sites
  • Service de Neurologie Vasculaire Groupement Hospitalier Est
    Bron, 69477, France
  • Sleep Medicine Center, Croix-Rousse Hospital, Hospices Civils de Lyon
    Lyon, 69004, France
  • Service de MPR- Hôpital Henry Gabrielle - Groupement Sud
    Saint-Genis-Laval, 69230, France
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Nov 2017 to primary completion in Jun 2022, 54 months.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 5, 2017
First posted
Sep 7, 2017
StartActual
Nov 14, 2017
Primary completionActual
Jun 11, 2022
CompletionActual
Nov 3, 2022
Last update
Jul 23, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 23, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03274505
Responsible party
Sponsor
First posted
Sep 7, 2017
Start date
Nov 14, 2017
Primary completion
Jun 11, 2022
Completion
Nov 3, 2022
Last update
Jul 23, 2024

Study contacts

Laure PETER-DEREX, MD, PhD
principal investigator · Centre de Médecine du Sommeil et des Maladies respiratoires, CH de la Croix Rousse - HCL

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2024. You cannot join it, but the record below documents what was studied.

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Discussion

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