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

Sponsor

Helle Klingenberg Iversen, MD, DmSc (Other)

Overall Status

Completed

CT.gov ID

NCT02111408

Collaborator

(none)

114

Enrollment

Location

Duration (Months)

1.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
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:

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.

Study Design

Study Type:

Observational

Actual Enrollment :

114 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Study Start Date :

Mar 1, 2014

Actual Primary Completion Date :

Feb 1, 2017

Actual Study Completion Date :

Mar 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Acute stroke No interventions. Only tests for depression, sleepapnea and autonomic dysfunction.

Outcome Measures

Primary Outcome Measures

Sleep disordered breathing at any time after stroke. [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.
Autonomic dysfunction at any time after stroke. [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.
Depression at any time after stroke [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 Outcome Measures

Peripheral artery disease at any time after stroke [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 Outcome Measures

New vascular episodes at any time after stroke [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.
Death by cause at any time after stroke [Assessed at follow-up after six month]
Assessed at follow-up after six month and five years

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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