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

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02111408
• Other study ID #: VEK: H-2-3013-091
• Secondary ID: H-2-3013-091
• Status: Completed
• Start date: March 2014
• Est. completion date: March 2022

Study information

• Verified date: March 2022
• Source: Glostrup University Hospital, Copenhagen
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 114
• Est. completion date: March 2022
• Est. primary completion date: February 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Depression
• Parasomnias
• Sleep Wake Disorders
• Stroke

Locations

Country	Name	City	State
Denmark	Department of clinical stroke research, department of neurology, Glostrup Hospital	Glostrup

Sponsors (1)

Lead Sponsor	Collaborator
Helle Klingenberg Iversen, MD, DmSc

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Primary	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
Primary	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
Primary	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	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