NCT02111408

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
114

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2014

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2014

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

April 3, 2014

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 11, 2014

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2017

Completed
5.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2022

Completed
Last Updated

March 29, 2022

Status Verified

March 1, 2022

Enrollment Period

2.9 years

First QC Date

April 3, 2014

Last Update Submit

March 27, 2022

Conditions

Stroke

Keywords

Sleep apnea syndromesAutonomic nervous system +/- diseaseDepressionPeripheral arterial disease

Outcome Measures

Primary Outcomes (3)

  • 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

  • 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

  • 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 Outcomes (1)

  • Peripheral artery disease at any time after stroke

    six month after the stroke

Other Outcomes (2)

  • New vascular episodes at any time after stroke

    Assessed at follow-up after six month

  • Death by cause at any time after stroke

    Assessed at follow-up after six month

Study Arms (1)

Acute stroke

No interventions. Only tests for depression, sleepapnea and autonomic dysfunction.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The study population is recruited among patients admitted at the acute stroke unit at Glostrup university hospital.

You may qualify if:

  • Clinical stroke either ischaemic or haemorrhagic

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Glostrup Municipality, 2600, Denmark

Location

Related Publications (1)

  • 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.

    PMID: 34476728DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood, plasma, serum

MeSH Terms

Conditions

StrokeSleep Apnea SyndromesDepressionPeripheral Arterial Disease

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersBehavioral SymptomsBehaviorAtherosclerosisArteriosclerosisArterial Occlusive DiseasesPeripheral Vascular Diseases

Study Officials

  • Helle Iversen, MD, DMSc

    Stroke research, Glostrup hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
M.D.

Study Record Dates

First Submitted

April 3, 2014

First Posted

April 11, 2014

Study Start

March 1, 2014

Primary Completion

February 1, 2017

Study Completion

March 1, 2022

Last Updated

March 29, 2022

Record last verified: 2022-03

Locations

DK(1)