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

NCT ID: NCT02111408

Last Updated: 2022-03-29

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 114 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2014-03-31
• Study Completion Date: 2022-03-31

Brief Summary

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.

Detailed 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.

Conditions

Stroke

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Acute stroke

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

No interventions assigned to this group

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Helle Klingenberg Iversen, MD, DmSc

OTHER

Sponsor Role: lead

Responsible Party

Helle Klingenberg Iversen, MD, DmSc

M.D.

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Helle Iversen, MD, DMSc

Role: PRINCIPAL_INVESTIGATOR

Stroke research, Glostrup hospital

Locations

Department of clinical stroke research, department of neurology, Glostrup Hospital

Glostrup Municipality, , Denmark

Countries

Denmark

References

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.

Reference Type: DERIVED

PMID: 34476728 (View on PubMed)

Other Identifiers

H-2-3013-091

Identifier Type: OTHER

Identifier Source: secondary_id

VEK: H-2-3013-091

Identifier Type: -

Identifier Source: org_study_id