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Sleep Deficiency and Stroke Outcome

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ClinicalTrials.gov Identifier: NCT02559739
Recruitment Status : Recruiting
First Posted : September 24, 2015
Last Update Posted : May 9, 2017
Sponsor:
Collaborators:
Neurocenter of Southern Switzerland
Swiss Heart Foundation
Information provided by (Responsible Party):
University Hospital Inselspital, Berne

Brief Summary:

Deficient sleep duration and sleep disturbances - such as insomnia, sleep disordered breathing (SDB) and restless legs syndrome (RLS)- are associated with hypertension and cardio-cerebrovascular morbidity and mortality. Several studies suggest that sleep disorders are frequent after stroke and detrimental for stroke outcome. However, more prospective studies in a large unselected sample of stroke survivors are needed to better investigate the short- and long-term consequences of sleep disturbances on mortality and occurrence of new cardio-cerebrovascular events. Also their pathophysiological mechanisms and their influence on stroke recovery should be better understood.

Therefore, the aim of this study is to assess the impact of sleep deficiency and sleep fragmentation on the frequency of new cerebro- and cardiovascular events and death after stroke or transient ischemic attacks, and clinical outcome within one and two years after stroke.

The working hypotheses are that stroke survivors with sleep deficiency and sleep fragmentation due to insomnia, sleep-disordered breathing or restless leg syndrome will present: (1) higher mortality from all causes and higher frequency of new cardio-/ cerebrovascular events; and (2) a less favorable clinical outcome. Outcomes will be compared between patients with and without sleep deficiency and fragmentation.

Since current clinical practice in cerebrovascular patients does not sufficiently consider sleep disorders in patient's management, this study can help to bring attention to a still overlooked medical problem and change the current standard of management of stroke survivors.


Condition or disease
Sleep Apnea Syndromes Sleep Initiation and Maintenance Disorders Insomnia Restless Legs Syndrome Stroke

  Show Detailed Description

Study Type : Observational
Estimated Enrollment : 520 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Sleep Deficiency and Sleep Fragmentation and Their Impact on the Short- and Long-term Outcome of Ischemic Stroke and Transient Ischemic Attacks - a Two-center Prospective Observational Cohort Study
Study Start Date : July 2015
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : June 2019

Resource links provided by the National Library of Medicine


Group/Cohort
Sleep deficiency/fragmentation
Patients with sleep deficiency/fragmentation
No sleep deficiency/fragmentation
Patients without sleep deficiency/fragmentation



Primary Outcome Measures :
  1. A composite of death from any cause, stroke, transient ischemic attack, myocardial infarction, unplanned hospitalization (or unplanned prolongation of hospitalization) for heart failure or leading to urgent revascularization within 24 months [ Time Frame: 24 months after stroke ]

Secondary Outcome Measures :
  1. Clinical outcome after stroke, as assessed by modified Rankin scale [ Time Frame: 12 months after stroke ]
  2. Clinical outcome after stroke, as assessed by Barthel index [ Time Frame: 12 months after stroke ]
  3. Clinical outcome after stroke, as assessed by Quality of Life Questionnaire [ Time Frame: 12 months after stroke ]
  4. A composite of death from any cause, stroke, transient ischemic attack, myocardial infarction, unplanned hospitalization (or unplanned prolongation of hospitalization) for heart failure or leading to urgent revascularization) [ Time Frame: 3 and 12 months and 2 to 4 years after stroke ]
  5. Frequency of new-onset sleep deficiency [ Time Frame: 3, 12 and 24 months after stroke ]
  6. Frequency of insomnia [ Time Frame: 3, 12 and 24 months after stroke ]
  7. Frequency of RLS [ Time Frame: 3, 12 and 24 months after stroke ]
  8. Risk for sleep-disordered breathing [ Time Frame: 3, 12 and 24 months after stroke ]
  9. Arterial stiffness (assessed in 1/5 of all patients) [ Time Frame: Baseline, 3 and 12 months after stroke ]
  10. Endothelial function (assessed in 1/5 of all patients) [ Time Frame: Baseline, 3 and 12 months after stroke ]
  11. Blood pressure values (variability and absolute values, assessed in 1/5 of all patients 3 times a day over 3 weeks) [ Time Frame: Baseline, 3 and 12 months after stroke ]
  12. 3-week wrist-actigraphy parameters (including inactivity and activity indices) (assessed in 1/5 of all patients) [ Time Frame: Baseline, 3 and 12 months after stroke ]
  13. Basic cognitive performance (Montreal Cognitive Assessment) (assessed in 1/5 of all patients) [ Time Frame: Baseline, 3 and 12 months after stroke ]
  14. Course of SDB frequency measured by an objective respirography (assessed in 1/5 of all patients) [ Time Frame: Baseline, 3 and 12 months after stroke ]


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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients suffering from ischemic stroke or transient ischemic attack (TIA) will be recruited at the Stroke Unit and the ward of the Department of Neurology, Inselspital Bern, and the Stroke Unit and ward of the Neurocenter of Southern Switzerland, Lugano, and followed-up for (at least) 2 (maximum 4) years. They will be evaluated for pre-existing and new-onset sleep disturbances that result in sleep deficiency (< 6h sleep /night and/or post-stroke reduction of average sleep time/night ≥ 2h) or sleep fragmentation (insomnia, sleep-disordered breathing, restless legs syndrome).
Criteria

Inclusion Criteria:

  • Patients' informed consent as documented by signature.
  • Hospitalization either at the Stroke Unit and ward of the Department of Neurology, Inselspital Bern or at the Stroke Unit and ward of the Neurocenter of Southern Switzerland (Lugano)
  • Age: 18-85
  • Transient ischemic attack or ischemic stroke of any localization
  • Symptom onset until study inclusion ≤ 7 days
  • Written informed consent

Exclusion Criteria

  • Primary hemorrhagic stroke
  • Coma/Stupor
  • Clinical unstable or life threatening condition (severe heart failure, oxygen-dependent pulmonary disease or severe pulmonary complications, severe renal or liver insufficiency)
  • Pregnancy
  • Drug or alcohol abuse
  • Inability of the participant to give informed consent (e.g. patients under tutelage) or to follow the procedures of the study due to psychological or medical conditions

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02559739


Contacts
Contact: Claudio L Bassetti, Prof. Dr. med. +41 (0)31 632 30 66 claudio.bassetti@insel.ch
Contact: Frédéric Zubler, Dr. med. +41 (0)31 632 30 54 frederic.zubler@insel.ch

Locations
Switzerland
Department of Neurology Inselspital, Bern University Hospital Recruiting
Bern, Canton Bern, Switzerland, 3010
Contact: Claudio L Bassetti, Prof. Dr. med.    +41 (0)31 632 30 66    claudio.bassetti@insel.ch   
Contact: Simone Duss, Dr. med.    +41 (0)31 632 30 54    simone.duss@insel.ch   
Sub-Investigator: Thomas Horvath, MD         
Sub-Investigator: Sebastian Ott, MD         
Sleep and Epilepsy Center, Neurocenter of Southern Switzerland, Civic Hospital of Lugano Active, not recruiting
Lugano, Switzerland, 6900
Sponsors and Collaborators
University Hospital Inselspital, Berne
Neurocenter of Southern Switzerland
Swiss Heart Foundation
Investigators
Principal Investigator: Claudio L Bassetti, Prof. Dr. med. Chairman and Head, Department of Neurology Inselspital, Bern University Hospital
Principal Investigator: Mauro Manconi, Dr. med. Head of Sleep and Epilepsy Center, Neurocenter of Southern Switzerland, Lugano

Publications:
Responsible Party: University Hospital Inselspital, Berne
ClinicalTrials.gov Identifier: NCT02559739     History of Changes
Other Study ID Numbers: 014/15
320030_149752 ( Other Grant/Funding Number: SNF grant )
First Posted: September 24, 2015    Key Record Dates
Last Update Posted: May 9, 2017
Last Verified: May 2017

Keywords provided by University Hospital Inselspital, Berne:
Stroke
Ischemic Attack, Transient
Cardiovascular Diseases
Sleep Apnea Syndromes
Sleep Initiation and Maintenance Disorders
Insomnia
Restless Legs Syndrome
Sleep Deprivation

Additional relevant MeSH terms:
Syndrome
Stroke
Sleep Apnea Syndromes
Sleep Initiation and Maintenance Disorders
Psychomotor Agitation
Restless Legs Syndrome
Disease
Pathologic Processes
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Apnea
Respiration Disorders
Respiratory Tract Diseases
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Mental Disorders
Dyskinesias
Neurologic Manifestations
Psychomotor Disorders
Neurobehavioral Manifestations
Signs and Symptoms
Parasomnias