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Completed

NCT Number: NCT02111408

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.

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Key information

Conditions

Stroke Apnea Arterial Occlusive Diseases Arteriosclerosis Atherosclerosis Behavior Behavioral Symptoms Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Depression Dyssomnias Nervous System Diseases Peripheral Arterial Disease Peripheral Vascular Diseases Respiration Disorders Respiratory Tract Diseases Sleep Apnea Syndromes Sleep Disorders, Intrinsic Sleep Wake Disorders Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Glostrup Municipality, 2600, Denmark

About this study

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:

  • Stroke patients with SDB have an impaired autonomic function
  • Stroke patients with SDB have an increased risk of PSD
  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Sleep disordered breathing at any time after stroke.

    Time frame: six month 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.

  2. Autonomic dysfunction at any time after stroke.

    Time frame: six month after the 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.

  3. Depression at any time after stroke

    Time frame: six month after the 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

Secondary outcomes

  1. Peripheral artery disease at any time after stroke

    Time frame: six month after the 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.

Other outcomes

  1. New vascular episodes at any time after stroke

    Time frame: Assessed at follow-up after six month

    Assessed at follow-up after six month and five years. Stroke, TIA, acute coronary syndrome or operation for peripheral vascular disease.

  2. Death by cause at any time after stroke

    Time frame: Assessed at follow-up after six month

    Assessed at follow-up after six month and five years

Sponsors and collaborators

Lead sponsor

Helle Klingenberg Iversen, MD, DmSc

Other

Registry information

Important dates

Study start
2014
Primary completion
2017
Study completion
2022
First posted
Apr 11, 2014
Registry last updated
Mar 29, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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