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| ID | Type | Description | Link |
|---|---|---|---|
| H-2-3013-091 | Other Identifier | Research Ethics Committee |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Acute stroke | No interventions. Only tests for depression, sleepapnea and autonomic dysfunction. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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 | six month after the stroke |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | six month after the stroke |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Assessed at follow-up after six month |
| Death by cause at any time after stroke |
Inclusion Criteria:
• Clinical stroke either ischaemic or haemorrhagic
Exclusion Criteria:
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The study population is recruited among patients admitted at the acute stroke unit at Glostrup university hospital.
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| Name | Affiliation | Role |
|---|---|---|
| Helle Iversen, MD, DMSc | Stroke research, Glostrup hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of clinical stroke research, department of neurology, Glostrup Hospital | Glostrup Municipality | 2600 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34476728 | Derived | Simonsen SA, Andersen AV, West AS, Wolfram F, Jennum P, Iversen HK. Sleep-disordered breathing and cerebral small vessel disease-acute and 6 months after ischemic stroke. Sleep Breath. 2022 Sep;26(3):1107-1113. doi: 10.1007/s11325-021-02482-1. Epub 2021 Sep 2. |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| D012891 | Sleep Apnea Syndromes |
| D003863 | Depression |
| D058729 | Peripheral Arterial Disease |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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Whole blood, plasma, serum
Assessed at follow-up after six month and five years |
| Assessed at follow-up after six month |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D050197 | Atherosclerosis |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D016491 | Peripheral Vascular Diseases |