StrokeNCT02111408
Stroke - Sleep Disorders, Dysfunction of the Autonomic Nervous System and Depression
An observational study of Stroke, run by Helle Klingenberg Iversen, MD, DmSc at 1 site in Denmark.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke
- How many people
- 114 participants
- Where
- 1 siteDenmark
- Study dates
- Mar 2014to Mar 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population is recruited among patients admitted at the acute stroke unit at Glostrup university hospital.
Who may be able to join
- Clinical stroke either ischaemic or haemorrhagic
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Department of clinical stroke research, department of neurology, Glostrup Hospital
Glostrup Municipality, 2600
About this study
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.
Read the 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.
- Conditions
- Stroke
- Keywords
- Sleep apnea syndromes, Autonomic nervous system +/- disease, Depression, Peripheral arterial disease
- Medical subject headings
- Stroke, Sleep Apnea Syndromes, Depression, Peripheral Arterial Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Acute stroke | No interventions. Only tests for depression, sleepapnea and autonomic dysfunction. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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
Measured: six month after the stroke
Secondary outcomes (1)
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.
Measured: six month after the stroke
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2014 (estimated)
- Study startMar 2014
- Primary completionFeb 2017
- Study completionMar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 114 participants (actual)
Sponsor and investigators
- Lead sponsor
- Helle Klingenberg Iversen, MD, DmSc
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Helle Klingenberg Iversen, MD, DmSc, Glostrup University Hospital, Copenhagen
- Investigators
- Helle Iversen, MD, DMSc, Principal investigator, Stroke research, Glostrup hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02111408
- Sponsor's protocol ID
- VEK: H-2-3013-091
- Other IDs
- H-2-3013-091
- Status last verified
- Mar 2022
- First submitted
- 3 Apr 2014
- Last updated
- 29 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
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.
PubMed 34476728
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stroke - Sleep Disorders, Dysfunction of the Autonomic Nervous System and Depression
- ClinicalTrials.gov ID
- NCT02111408
- Acronym / sponsor ID
- VEK: H-2-3013-091
- Conditions
- Stroke
- Keywords
- Sleep apnea syndromes, Autonomic nervous system +/- disease, Depression, Peripheral arterial disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 114 participants (actual)
- Lead sponsor
- Helle Klingenberg Iversen, MD, DmScUniversity, hospital or other
- Study start
- Mar 2014
- Primary completion
- Feb 2017 (actual)
- Study completion
- Mar 2022 (actual)
- First posted
- 11 Apr 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Acute stroke | – | –No interventions. Only tests for depression, sleepapnea and autonomic dysfunction. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population is recruited among patients admitted at the acute stroke unit at Glostrup university hospital.
Key inclusion criteria (1 listed)
- Clinical stroke either ischaemic or haemorrhagic
Key exclusion criteria (8 listed)
- Transitory ischemic attac
- Congenital or acquired brain disease, other than stroke
- Dementia
- Mental retardation
- Fatal stroke or severe comorbidities with short expected life
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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.
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
1 secondary outcome
Peripheral artery disease at any time after stroke
Time frame: six month after the stroke
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2022.
- Derived from this study: PubMed 34476728Simonsen 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.
- Individual participant dataSharing planned: Undecided
Related trials for Stroke
Not yet recruiting
Temporal Interference Stimulation for Upper-Limb Motor Recovery in Early Subacute Stroke
Acute Ischemic Stroke
RecruitingObservational study
ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
Acute Ichemic Stroke
Recruiting
Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
Stroke, Upper Extremity Paresis
Recruiting
Early Motor-Cognitive Integrative Training on Cognitive and Motor Performance in Patients With Aneurysmal Subarachnoid Hemorrhage
Subarachnoid Aneurysm Hemorrhage
Not yet recruiting
Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
Acute Ischemic Stroke, Basilar Artery Occlusion
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Helle Iversen, MD, DMSc principal investigator
Stroke research, Glostrup hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke, run by Helle Klingenberg Iversen, MD, DmSc at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sleep disordered breathing at any time after stroke. (time frame: six month after stroke). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02111408, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Mar 2022.