Clinical trial NCT02111408: Stroke - Sleep Disorders, Dysfunction of the Autonomic Nervous System and Depression
Official title: Stroke - Sleep Disorders, Dysfunction of the Autonomic Nervous System and Depression
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Stroke
Keywords: Sleep apnea syndromes
Autonomic nervous system +/- disease
Depression
Peripheral arterial disease
Lead sponsor: Glostrup University Hospital, Copenhagen
Sponsor class: OTHER
First posted: 2014-04-11
Enrollment: 114
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population is recruited among patients admitted at the acute stroke unit at Glostrup university hospital.

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.

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

Primary outcomes:
measure: Sleep disordered breathing at any time after stroke.
timeFrame: six month after stroke
measure: Autonomic dysfunction at any time after stroke.
timeFrame: six month after the stroke
measure: Depression at any time after stroke
timeFrame: six month after the stroke
Secondary outcomes:
measure: Peripheral artery disease at any time after stroke
timeFrame: six month after the stroke
Other outcomes:
measure: New vascular episodes at any time after stroke
timeFrame: Assessed at follow-up after six month
measure: Death by cause at any time after stroke
timeFrame: Assessed at follow-up after six month
Locations:
city: Glostrup
country: Denmark
facility: Department of clinical stroke research, department of neurology, Glostrup Hospital
Study officials:
affiliation: Stroke research, Glostrup hospital
name: Helle Iversen, MD, DMSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.