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Trial record 27 of 56 for:    Recruiting, Not yet recruiting, Available Studies | "Ischemic Attack, Transient"

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

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ClinicalTrials.gov Identifier: NCT03274505
Recruitment Status : Recruiting
First Posted : September 7, 2017
Last Update Posted : February 5, 2018
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Sleep Disorder Stroke Other: Questionnaires

Study Type : Observational
Estimated 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 : November 14, 2017
Estimated Primary Completion Date : August 14, 2019
Estimated Study Completion Date : August 14, 2019

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/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)




Primary Outcome Measures :
  1. 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)



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Stroke and transient ischemic attack patients
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03274505


Contacts
Contact: Laure PETER-DEREX, MD, PhD 04 72 07 17 69 ext +33 laure.peter-derex@chu-lyon.fr

Locations
France
Service de Neurologie Vasculaire Groupement Hospitalier Est Recruiting
Bron, France, 69477
Sub-Investigator: Laurent Derex, PH         
Sub-Investigator: Elodie Ong, PH         
Sleep Medicine Center, Croix-Rousse Hospital, Hospices Civils de Lyon Active, not recruiting
Lyon, France, 69004
Service de MPR- Hôpital Henry Gabrielle - Groupement Sud Recruiting
Saint-Genis-Laval, France, 69230
Sub-Investigator: Jacques Luauté, PU-PH         
Sub-Investigator: Sophie Jacquin Courtois, PU-PH         
Sub-Investigator: Maxime Cheminon, PH         
Sub-Investigator: Laure Huchon, PH         
Sponsors and Collaborators
Hospices Civils de Lyon

Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT03274505     History of Changes
Other Study ID Numbers: 69HCL17_0418
First Posted: September 7, 2017    Key Record Dates
Last Update Posted: February 5, 2018
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
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:
Ischemic Attack, Transient
Disease
Stroke
Sleep Wake Disorders
Parasomnias
Pathologic Processes
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Neurologic Manifestations
Signs and Symptoms
Mental Disorders
Brain Ischemia