Stroke - Sleep Disorders, Dysfunction of the Autonomic Nervous System and Depression
Descripción general del estudio
Estado
Condiciones
Descripción detallada
Up to fifty percent of stroke patients suffer less noticeable comorbidities after the acute phase of a stroke and often the rest of their life. It concerns sleep disordered breathing (SDB), post stroke depression (PSD), and dysfunction of the autonomic nervous system. These comorbidities are seldom recognized, but are associated with a poorer outcome after stroke, reduced quality of life as well as an increased risk of new vascular events.
Little is known about the course of the comorbidities, the relationship between the mentioned diseases or which patients are more commonly affected.
The investigators will investigate the following hypotheses, and assess the results compared to the stroke aetiology:
- Stroke patients with SDB have an impaired autonomic function
- Stroke patients with SDB have an increased risk of PSD
- Stroke patients with autonomic dysfunction have an increased risk of PSD
The investigators will examine stroke patients for signs of sleep disordered breathing, autonomic dysfunction and depression, both in the acute phase (days), in the chronic phase (months) and the very chronic state (years). Thereby the investigators can map the comorbidities course over time. At the same time the patients will be tested for peripheral small and large artery disease as well as MRI will be used to investigate sign of cerebral small vessel disease.
Based on power calculations 335 individuals will be enrolled in order to satisfy the project requirements.
Tipo de estudio
Inscripción (Actual)
Contactos y Ubicaciones
Ubicaciones de estudio
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Glostrup, Dinamarca, 2600
- Department of clinical stroke research, department of neurology, Glostrup Hospital
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
Descripción
Inclusion Criteria:
• Clinical stroke either ischaemic or haemorrhagic
Exclusion Criteria:
- Transitory ischemic attac
- Congenital or acquired brain disease, other than stroke
- Dementia
- Mental retardation
- Fatal stroke or severe comorbidities with short expected life
- Pregnancy or breastfeeding
- Altered consciousness e.g. delirium or status epilepticus
- Other cause of the patient, according to the investigator believes, can not complete the study
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Modelos observacionales: Grupo
- Perspectivas temporales: Futuro
Cohortes e Intervenciones
Grupo / Cohorte |
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Acute stroke
No interventions.
Only tests for depression, sleepapnea and autonomic dysfunction.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Sleep disordered breathing at any time after stroke.
Periodo de tiempo: six month after stroke
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The test for sleep disordered breathing will be performed within 7 days from stroke onset and after 6 month and five years. Mild sleep apnea if AHI between 5 and 15, moderate sleep apnea if AHI between 15 and 30 and severe sleep apnea if AHI above 30. Subdivided into obstructive, central or mixed. |
six month after stroke
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Autonomic dysfunction at any time after stroke.
Periodo de tiempo: six month after the stroke
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The test for autonomic dysfunction will be performed within 7 days from stroke onset and after 6 month and five years. Abnormal result of the valsalva manoeuvre, deep breathing, active standing or tilt table test. Improvement or worsening of the parameters like HRV, BRS and CO during the study period. |
six month after the stroke
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Depression at any time after stroke
Periodo de tiempo: six month after the stroke
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The test for depression will be performed within 7 days from stroke onset and after 6 month and five years. Mild, moderate or severe depression according to HAM-D6, MDI or HADS |
six month after the stroke
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Peripheral artery disease at any time after stroke
Periodo de tiempo: six month after the stroke
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The tests will be performed within 7 days from stroke onset and after 6 month and five years. Stenosis of the carotid artery, abnormal ankle-brachial index or endothelial dysfunction. |
six month after the stroke
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Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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New vascular episodes at any time after stroke
Periodo de tiempo: Assessed at follow-up after six month
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Assessed at follow-up after six month and five years.
Stroke, TIA, acute coronary syndrome or operation for peripheral vascular disease.
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Assessed at follow-up after six month
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Death by cause at any time after stroke
Periodo de tiempo: Assessed at follow-up after six month
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Assessed at follow-up after six month and five years
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Assessed at follow-up after six month
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Helle Iversen, MD, DMSc, Stroke research, Glostrup hospital
Publicaciones y enlaces útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Síntomas de comportamiento
- Desordenes mentales
- Enfermedades cardiovasculares
- Enfermedades Vasculares
- Trastornos cerebrovasculares
- Enfermedades Cerebrales
- Enfermedades del Sistema Nervioso Central
- Enfermedades del Sistema Nervioso
- Manifestaciones neurológicas
- Carrera
- Depresión
- Trastornos del sueño y la vigilia
- Parasomnias
Otros números de identificación del estudio
- VEK: H-2-3013-091
- H-2-3013-091 (Otro identificador: Research Ethics Committee)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
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