Stroke - Sleep Disorders, Dysfunction of the Autonomic Nervous System and Depression

Helle Klingenberg Iversen, MD, DmSc

Status: Completed

Conditions: Stroke

Study type: Observational

Funder types: Other

Identifiers

NCT02111408

VEK: H-2-3013-091

H-2-3013-091 (Other Identifier)

Details and patient eligibility

About

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.

Full description

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:

1. Stroke patients with SDB have an impaired autonomic function
2. Stroke patients with SDB have an increased risk of PSD
3. 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.

Enrollment: 114 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

114 participants in 1 patient group

Acute stroke

Description:

No interventions. Only tests for depression, sleepapnea and autonomic dysfunction.