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

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.

Study Overview

• Status: Completed
• Conditions: Stroke

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.

• Study Type: Observational
• Enrollment (Actual): 114

Contacts and Locations

Study Locations

• Denmark
  • Glostrup, Denmark, 2600
    • Department of clinical stroke research, department of neurology, Glostrup Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

The study population is recruited among patients admitted at the acute stroke unit at Glostrup university hospital.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Acute stroke; No interventions. Only tests for depression, sleepapnea and autonomic dysfunction.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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

Other Outcome Measures

Outcome Measure	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	Assessed at follow-up after six month and five years	Assessed at follow-up after six month

Collaborators and Investigators

• Sponsor: Helle Klingenberg Iversen, MD, DmSc
• Investigators: Principal Investigator: Helle Iversen, MD, DMSc, Stroke research, Glostrup hospital

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: March 1, 2014
• Primary Completion (Actual): February 1, 2017
• Study Completion (Actual): March 1, 2022

Study Registration Dates

• First Submitted: April 3, 2014
• First Submitted That Met QC Criteria: April 9, 2014
• First Posted (Estimate): April 11, 2014

Study Record Updates

• Last Update Posted (Actual): March 29, 2022
• Last Update Submitted That Met QC Criteria: March 27, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: Depression; Peripheral arterial disease; Sleep apnea syndromes; Autonomic nervous system +/- disease
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Stroke; Depression; Sleep Wake Disorders; Parasomnias
• Other Study ID Numbers: VEK: H-2-3013-091; H-2-3013-091 (Other Identifier: Research Ethics Committee)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided