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

Sponsor
Hospices Civils de Lyon (Other)
Overall Status
Recruiting
CT.gov ID
NCT03274505
Collaborator
(none)
200
Enrollment
3
Locations
69
Anticipated Duration (Months)
66.7
Patients Per Site
1
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or DiseaseIntervention/TreatmentPhase
  • Other: Questionnaires

Study Design

Study Type:
Observational
Anticipated Enrollment :
200 participants
Observational Model:
Cohort
Time Perspective:
Cross-Sectional
Official Title:
Comparison of the Prevalence of Sleep Disorders in Transient Ischemic Attack and Stroke
Actual Study Start Date :
Nov 14, 2017
Anticipated Primary Completion Date :
Nov 14, 2022
Anticipated Study Completion Date :
Aug 14, 2023

Arms and Interventions

ArmIntervention/Treatment
Stroke patients

Patients seen by a rehabilitation physician at a routine 3 months' post-stroke examination

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)

TIA patients

Patients seen by a stroke specialist at the "SOS TIA" examination

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)

Outcome Measures

Primary Outcome Measures

  1. 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)

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
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

Contacts and Locations

Locations

SiteCityStateCountryPostal Code
1Service de Neurologie Vasculaire Groupement Hospitalier EstBronFrance69477
2Sleep Medicine Center, Croix-Rousse Hospital, Hospices Civils de LyonLyonFrance69004
3Service de MPR- Hôpital Henry Gabrielle - Groupement SudSaint-Genis-LavalFrance69230

Sponsors and Collaborators

  • Hospices Civils de Lyon

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Hospices Civils de Lyon
ClinicalTrials.gov Identifier:
NCT03274505
Other Study ID Numbers:
  • 69HCL17_0418
First Posted:
Sep 7, 2017
Last Update Posted:
Nov 16, 2021
Last Verified:
Nov 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 16, 2021