An observational study in Stroke, sponsored by Helle Klingenberg Iversen, MD, DmSc. Completed at 1 site in Denmark. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-03-29.
Sponsored by Helle Klingenberg Iversen, MD, DmSc · Observational
The purpose of this study is to investigate sleep disordered breathing, autonomic dysfunction, and post stroke depression in acute and chronic stroke patients. Furthermore, to explore the interaction between these comorbidities, and their relation to stroke aetiology.
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:
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.
7,286 studies on the registry are indexed under Stroke; 2,007 are open to participants now.
This study's enrollment of 114 is below the median of 160 across 1,692 observational studies indexed under Stroke.
Browse Stroke studies →Helle Klingenberg Iversen, MD, DmSc is the lead sponsor of 2 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
The study population is recruited among patients admitted at the acute stroke unit at Glostrup university hospital.
Exclusion Criteria:
No interventions. Only tests for depression, sleepapnea and autonomic dysfunction.
Sleep disordered breathing at any time 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.
Time frame: six month after stroke
Autonomic dysfunction at any time after 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.
Time frame: six month after the stroke
Depression at any time after 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
Time frame: six month after the stroke
Peripheral artery disease at any time after 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.
Time frame: six month after the stroke
New vascular episodes at any time after stroke
Assessed at follow-up after six month and five years. Stroke, TIA, acute coronary syndrome or operation for peripheral vascular disease.
Time frame: Assessed at follow-up after six month
Death by cause at any time after stroke
Assessed at follow-up after six month and five years
Time frame: Assessed at follow-up after six month
Plan to share: Undecided
This study is completed, as verified in Mar 2022. You cannot join it, but the record below documents what was studied.
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Helle Klingenberg Iversen, MD, DmSc