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Trial record 3 of 3 for:    22618924 [PUBMED-IDS]

Early Sleep Apnea Treatment in Stroke (eSATIS)

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ClinicalTrials.gov Identifier: NCT02554487
Recruitment Status : Recruiting
First Posted : September 18, 2015
Last Update Posted : February 5, 2019
Sponsor:
Collaborators:
Swiss National Science Foundation
TROPOS Stiftung für Humane Verhaltensforschung
Information provided by (Responsible Party):
University Hospital Inselspital, Berne

Brief Summary:

Investigating the interrelation of stroke and sleep-disordered breathing (SDB) is of major importance. First because of the high occurrence rate of stroke and the fact that it is a frequent cause of long-term disability in adulthood. Second because SDB (obstructive, central and mixed forms) affects more than 50% of stroke survivors and has a detrimental effect on clinical stroke outcome. Third, spontaneous and learning-dependent sleep-associated neuroplasticity may be affected by SDB following stroke worsening stroke rehabilitation. Therefore, it is crucial to investigate whether early treatment of SDB with Adaptive Servo-Ventilation (ASV), the treatment device of choice to treat obstructive, central and mixed forms of SDB, has a beneficial effect on the evolution of the lesion volume and on clinical stroke outcome.

To this end, the investigators recruit and prospectively follow 3 groups of patients with ischemic stroke over 1 year. During the first night after hospital admission due to acute stroke, nocturnal breathing is assessed by means of a respiratory polygraphy. Patients with significant sleep disordered breathing, defined as an Apnea-Hypopnea-Index (AHI) > 20/h, are randomized to ASV treatment or no treatment (sSDB ASV+ or sSDB ASV-). ASV treatment starts the second night following hospital admission and ends 90 days later. Stroke patients without SDB (AHI < 5 / h) serve as a control group (no SDB) to observe the evolution of the lesion volume and stroke outcome without the additional burden of SDB.

Lesion volume one day after hospital admission due to acute stroke (after potential lysis therapy) measured by Diffusion Weighted Imaging will be subtracted from lesion volume measured by T2-weighted volumetry assessed 90(+/-7) days following stroke and compared between patients with and without ASV treatment (sSDB ASV+ and sSDB ASV-) as well as patients without SDB (no SDB). Short- and long-term clinical stroke outcomes are assessed by clinical scales and questionnaires 4 to 7 days, 3 months and 1 year following stroke. Cognitive outcome is assessed during hospitalization (within the first week following stroke) and after the treatment period of 90 days by neuropsychological tests assessing attention and memory. In addition, baseline assessment of physiological parameters such as blood pressure and endothelial function/arterial stiffness are assessed during the first weeks following stroke and at the end of the treatment period, i.e. approximately 90 days following stroke.


Condition or disease Intervention/treatment Phase
Sleep Apnea, Obstructive Sleep Apnea, Central Stroke Device: AirCurveTM10 CS PACEWAVE Adaptive-Servo-Ventilator (ResMed Ldt., Australia) Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Early Sleep Apnea Treatment in Stroke: A Multicenter, Randomized, Rater-Blinded, Clinical Trial of Adaptive Servo-Ventilation
Actual Study Start Date : August 13, 2015
Estimated Primary Completion Date : October 2020
Estimated Study Completion Date : July 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sleep Apnea

Arm Intervention/treatment
Experimental: sSDB ASV+
sSDB ASV+: Patients with an AHI > 20/h assessed during the first night of stroke that are randomized to ASV treatment (AirCurveTM10 CS PACEWAVE Adaptive-Servo-Ventilator (ResMed Ldt., Australia)).
Device: AirCurveTM10 CS PACEWAVE Adaptive-Servo-Ventilator (ResMed Ldt., Australia)
Adaptive Servo-Ventilation (ASV) is a ventilator mode used to treat central and obstructive forms of sleep disordered breathing. It is authorized in Switzerland, bears a conformity marking (CE 0123) and it is used according to the approved indications. Stroke patients with an AHI > 20/h assessed within the first night following stroke that are randomized to ASV treatment, starting in the second night after stroke, are part of this group. The other half of patients are randomized to no treatment and patients without sleep disordered breathing (AHI < 5) following stroke serve as a control group

No Intervention: sSDB ASV-
sSDB ASV-: Patients with an AHI > 20 no ASV treatment.
No Intervention: no SDB
no SDB: Stroke patients without SDB (AHI < 5 / h) serve as a control group to observe the evolution of the lesion volume and stroke outcome without the additional burden of SDB.



Primary Outcome Measures :
  1. Infarct growth from baseline to 90 day following stroke: difference in lesion volume [ccm] assessed by Diffusion Weighted Imaging (DWI) at baseline and T2-weighted imaging at day 90 following stroke [ Time Frame: The day after admission and potential lysis therapy, at 4 to 7 days following stroke and 90 (+/-7 ) days following stroke ]

Secondary Outcome Measures :
  1. Relative salvage of the penumbra volume from the day after lysis therapy to day 4-7 following stroke will be compared between the three patients groups (sSDB ASV+, sSDB ASV-, no SDB) [ Time Frame: The day after admission/potential lysis therapy and at 4 to 7 days following stroke ]
  2. Differences in spatial/temporal dynamics of resting state connectivity between the three patients groups: sSDB ASV+, sSDB ASV-, no SDB [ Time Frame: The day after admission/potential lysis therapy, at day 4-7 and day 90 following stroke ]
  3. Differences in clinical outcome between the three patients groups, sSDB ASV+, sSDB ASV- and no SDB, assessed by the NIHSS, Barthel Index and the modified Rankin scale [ Time Frame: Pre-stroke assessment during hospitalization and post-stroke assessments at day 90 and 1 year following stroke ]
  4. Differences in blood pressure measurements (absolute values and variability) during hospitalisation, during a 3-week period following dismissal and during a 3-week period 90-days following stroke. [ Time Frame: 3 weeks following hospital discharge (baseline) and 3-weeks before end of intervention period (~day 69-90). ]
  5. Differences in endothelial functioning/arterial stiffness at day 2 (baseline) and at 90 days following stroke [ Time Frame: 3 weeks following hospital discharge (baseline) and 3-weeks before end of intervention period (~day 69-90). ]
  6. Stroke patients' tolerance of and compliance to the ASV intervention during the acute (within the first week following stroke) and subacute to chronic phase (within the first 3 months following stroke) [ Time Frame: Tolerance and compliance are assessed during hospitalization (between 2 and 7 following stroke), at a follow-up control visit (between day 28-42) and at the end of the treatment period (day 83-97). ]


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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
Criteria

Inclusion Criteria:

  • Informed consent as documented by signature
  • Admission to one of the participating centers
  • Age 18-85 years
  • Ischemic stroke detectable by neuroimaging, affecting internal carotid artery, anterior cerebral artery (ACA), middle cerebral artery (MCA), posterior cerebral artery (PCA) and/or branches thereof
  • Symptom onset to admission < 24 hours
  • AHI > 20/h or < 5/h

Exclusion Criteria

  • Primary hemorrhagic stroke
  • Secondary parenchymal haemorrhage (PH 1 and PH 2 according to ECASS; secondary haemorrhagic infarction HI 1 and HI 2 can be included)
  • Small strokes (diameter < 1.5cm)
  • Coma/Stupor
  • Intubation
  • Clinically unstable or life threatening condition (oxygen-dependent pulmonary disease or severe pulmonary complications, severe renal or liver insufficiency, agitated patient, patients under blood pressure-elevating substances >24h after stroke, patients that need decompressive carniectomy )
  • Heart failure defined as known congestive heart failure (CHF) functional class NYHA III-IV (New York Heart Association) OR CHF NYHA II and hospitalization caused by CHF in the preceding 24 months
  • OR left ventricular ejection fraction lower or equal 45% either known from preceding imaging method or found at the routine examination (echocardiography) during hospitalization
  • Oxygen supply > 2 l/min during day and night
  • Intermediate AHI value: ≥ 5/h and ≤ 20/h
  • Known progressive neurological diseases (such as dementia, Parkinson's disease or multiple sclerosis)
  • Drug or alcohol abuse (>14 units alcohol / week for males, >7 units alcohol / week for females)
  • Inability to follow study procedure
  • Pregnancy
  • Any given contraindications to MRI or MRI-contrast agent (allergy or severe renal impairment)
  • Any given contraindications to ASV treatment

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): NCT02554487


Locations
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France
Clinic universitaire de physiologie, sommeil et exercice, Centre Hospitalier Universitaire (CHU) de Grenoble Recruiting
Grenoble, France, 38043
Contact: Jean-Louis Pépin, Prof. Dr. med.    +33 476 765 516    jpepin@chu-grenoble.fr   
Germany
Department and Out-Patient Care of Neurology, Charité Center Neurology, Neurosurgery and Psychiatry CC 15, Department of Neurology with Experimental Neurology, Center for Stroke Research Berlin (CSB) Enrolling by invitation
Berlin, Germany, 10117
Universitätsmedizin der Johannes Gutenberg-Universität Mainz, HNO-Universitätsklinik, Klinik und Poliklinik für Neurologie Recruiting
Mainz, Germany, 55131
Contact: Haralampos Gouveris, PD Dr. med.       haralampos.gouveris@unimedizin-mainz.de   
Contact: Yaroslav Winter, PD Dr. med.       yaroslav.winter@unimedizin-mainz.de   
Russian Federation
Federal State Budgetary Institution "Almazov National Medical Research Centre" of the Ministry of Health of the Russian Federation Recruiting
Saint Petersburg, Russian Federation, 197341
Contact: Aleksandra Kontradi, Prof. Dr. med.    +7 (812) 702-37-33    konradi_ao@almazovcentre.ru   
Contact: Lyudmila Korostovtseva, Dr. med.    +7 (921) 909-88-73    lyudmila-korosto@yandex.ru   
Sub-Investigator: Yurii Sviryaev, Dr. med.         
Switzerland
Department of Neurology, Pulmonary Medicine and Institute of Diagnostic and Interventional Neuroradiology, Bern University Hospital Recruiting
Bern, Switzerland, 3010
Contact: Claudio L Bassetti, Prof. Dr. med.    +41 31 632 30 66    claudio.bassetti@insel.ch   
Contact: Simone B. Duss, Dr. phil.    0041 31 632 45 73    simone.duss@insel.ch   
Principal Investigator: Claudio L Bassetti, Prof. Dr. med.         
Sub-Investigator: Sebastian R Ott, Dr. med.         
Sub-Investigator: Roland Wiest, Prof. Dr. med.         
Neurology Department, Cantonal Hospital St.Gallen Recruiting
St.Gallen, Switzerland, 9007
Contact: Dominique Flügel, Dr. med.    +41 71 494 16 52    dominique.fluegel@kssg.ch   
Sponsors and Collaborators
University Hospital Inselspital, Berne
Swiss National Science Foundation
TROPOS Stiftung für Humane Verhaltensforschung
Investigators
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Principal Investigator: Claudio L Bassetti Department of Neurology, Bern University Hospital, 3010 Bern, Switzerland

Additional Information:
Publications of Results:

Other Publications:
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Responsible Party: University Hospital Inselspital, Berne
ClinicalTrials.gov Identifier: NCT02554487     History of Changes
Other Study ID Numbers: 016/15
2734 ( Other Identifier: Insel )
320030_149752 ( Other Grant/Funding Number: SNSF )
SNCTP000001521 ( Registry Identifier: Swiss National Clinical Trials Portal (SNCTP) )
33IC30_166827 ( Other Grant/Funding Number: SNSF )
First Posted: September 18, 2015    Key Record Dates
Last Update Posted: February 5, 2019
Last Verified: February 2019
Keywords provided by University Hospital Inselspital, Berne:
stroke
sleep disordered breathing
sleep apnea
infarct volume
penumbra
Additional relevant MeSH terms:
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Apnea
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Sleep Apnea, Central
Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders