Stroke - Sleep Disorders, Dysfunction of the Autonomic Nervous System and Depression
Studie Overzicht
Toestand
Conditie
Gedetailleerde beschrijving
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.
Studietype
Inschrijving (Werkelijk)
Contacten en locaties
Studie Locaties
-
-
-
Glostrup, Denemarken, 2600
- Department of clinical stroke research, department of neurology, Glostrup Hospital
-
-
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Bemonsteringsmethode
Studie Bevolking
Beschrijving
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
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Observatiemodellen: Cohort
- Tijdsperspectieven: Prospectief
Cohorten en interventies
Groep / Cohort |
|---|
|
Acute stroke
No interventions.
Only tests for depression, sleepapnea and autonomic dysfunction.
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Sleep disordered breathing at any time after stroke.
Tijdsspanne: six month after stroke
|
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
|
|
Autonomic dysfunction at any time after stroke.
Tijdsspanne: six month after the stroke
|
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
|
|
Depression at any time after stroke
Tijdsspanne: six month after the stroke
|
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
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Peripheral artery disease at any time after stroke
Tijdsspanne: six month after the stroke
|
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
|
Andere uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
New vascular episodes at any time after stroke
Tijdsspanne: Assessed at follow-up after six month
|
Assessed at follow-up after six month and five years.
Stroke, TIA, acute coronary syndrome or operation for peripheral vascular disease.
|
Assessed at follow-up after six month
|
|
Death by cause at any time after stroke
Tijdsspanne: Assessed at follow-up after six month
|
Assessed at follow-up after six month and five years
|
Assessed at follow-up after six month
|
Medewerkers en onderzoekers
Onderzoekers
- Hoofdonderzoeker: Helle Iversen, MD, DMSc, Stroke research, Glostrup hospital
Publicaties en nuttige links
Studie record data
Bestudeer belangrijke data
Studie start
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- VEK: H-2-3013-091
- H-2-3013-091 (Andere identificatie: Research Ethics Committee)
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .