Sleep Disordered Breathing in Transient Ischemic Attack (TIA)/Ischemic Stroke and Continuous Positive Airway Pressure (CPAP) Treatment Efficacy
NCT ID: NCT01097967
Last Updated: 2015-10-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
246 participants
INTERVENTIONAL
2010-07-31
2016-04-30
Brief Summary
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Detailed Description
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Sleep disordered breathing is an independent risk factor for cardiovascular morbidity and mortality and is frequent in patients with acute cerebrovascular events. In this study the investigators observe the association between sleep disordered breathing, hypertension, stroke and the evolution of blood markers for atherosclerosis as well as the efficacy of Continuous Positive Airway Pressure treatment in patients with acute or subacute cerebrovascular events.
The SAS CARE 1 study is planned to verify whether or not sleep disordered breathing has a detrimental 3 months effect on cardiovascular functions and markers after acute cerebrovascular events. The SAS CARE 2 study is designed to address whether or not the treatment of sleep disordered breathing with CPAP reduces the combined rate of mortality, stroke, cardiovascular events (myocardial infarction/revascularisation/instable angina/ hospitalisation for heart insufficiency) over a 24 months period in patients after acute cerebrovascular events.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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CPAP in sleepy patients with SDB
SDB defined as AHI \>=20 Sleepy defined as Epworth Sleepiness Score \>=10
CPAP
no CPAP in non sleepy patients with SDB
SDB defined as AHI \>=20 Sleepy defined as Epworth Sleepiness Score \>=10
No interventions assigned to this group
CPAP in non sleepy patients with SDB
SDB defined as AHI \>=20 Sleepy defined as Epworth Sleepiness Score \>=10
CPAP
Interventions
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CPAP
Eligibility Criteria
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Inclusion Criteria
* with clinical diagnosis of TIA or ischemic stroke
* admitted in a Stroke Unit within 2 days from onset of symptoms
* or with TIA or ischemic stroke within the last 60-90 days
* signed Informed Consent
Exclusion Criteria
* currently on CPAP or on CPAP during the last 3 months before stroke
* with non-ischemic events (intracerebral/subarachnoid haemorrhage)
* Patients with coma/stupor
* with borderline obstructive SDB (AHI 10-19)
* with any condition that interferes with the acceptance of CPAP treatment
35 Years
75 Years
ALL
No
Sponsors
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Swiss National Science Foundation
OTHER
Schweizerische Herzstiftung
OTHER
ResMed
INDUSTRY
Philips Respironics
INDUSTRY
Prof. Claudio Bassetti
OTHER_GOV
Responsible Party
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Prof. Claudio Bassetti
Dr. med. Claudio Bassetti
Principal Investigators
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Claudio Bassetti, Professor
Role: PRINCIPAL_INVESTIGATOR
Universitätsspital Bern (Inselspital) und Universität Bern
Carlo Cereda, Capo CLinica
Role: STUDY_CHAIR
Neurocentre of Southern Switzerland, Ospedale Civico
Sebastian Ott, MD
Role: STUDY_CHAIR
Pneumology, University Hospital, Bern
Lino Nobili, Prof. MD
Role: STUDY_CHAIR
Neurology, Stroke Unit, Ospedale Niguarda, Milan, Italy
Mauro Manconi, MD
Role: STUDY_CHAIR
Neurocentre of Southern Switzerland, Ospedale Civico
Peter Young, Prof. MD
Role: STUDY_CHAIR
Universitätsklinik Münster, Zentrum für Schlafmedizin
Locations
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University Hospital Münster
Münster, , Germany
Dipartimento Neuroscienze, Ospedale Niguarda
Milan, Lombardy, Italy
Inselspital, Universitätsklinik für Pneumologie
Bern, Canton of Bern, Switzerland
Ospedale San Giovanni
Bellinzona, Canton Ticino, Switzerland
Neurocenter of Southern Switzerland, Ospedale Civico
Lugano, Canton Ticino, Switzerland
Countries
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References
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Bassetti C, Aldrich MS, Chervin RD, Quint D. Sleep apnea in patients with transient ischemic attack and stroke: a prospective study of 59 patients. Neurology. 1996 Nov;47(5):1167-73. doi: 10.1212/wnl.47.5.1167.
Bassetti C, Aldrich MS. Sleep apnea in acute cerebrovascular diseases: final report on 128 patients. Sleep. 1999 Mar 15;22(2):217-23. doi: 10.1093/sleep/22.2.217.
Marin JM, Carrizo SJ, Vicente E, Agusti AG. Long-term cardiovascular outcomes in men with obstructive sleep apnoea-hypopnoea with or without treatment with continuous positive airway pressure: an observational study. Lancet. 2005 Mar 19-25;365(9464):1046-53. doi: 10.1016/S0140-6736(05)71141-7.
Bassetti CL, Milanova M, Gugger M. Sleep-disordered breathing and acute ischemic stroke: diagnosis, risk factors, treatment, evolution, and long-term clinical outcome. Stroke. 2006 Apr;37(4):967-72. doi: 10.1161/01.STR.0000208215.49243.c3. Epub 2006 Mar 16.
Martinez-Garcia MA, Soler-Cataluna JJ, Ejarque-Martinez L, Soriano Y, Roman-Sanchez P, Illa FB, Canal JM, Duran-Cantolla J. Continuous positive airway pressure treatment reduces mortality in patients with ischemic stroke and obstructive sleep apnea: a 5-year follow-up study. Am J Respir Crit Care Med. 2009 Jul 1;180(1):36-41. doi: 10.1164/rccm.200808-1341OC. Epub 2009 Apr 30.
Pace M, Camilo MR, Seiler A, Duss SB, Mathis J, Manconi M, Bassetti CL. Rapid eye movements sleep as a predictor of functional outcome after stroke: a translational study. Sleep. 2018 Oct 1;41(10). doi: 10.1093/sleep/zsy138.
Manconi M, Zavalko I, Cereda C, Pisarenco I, Ott S, Fulda S, Bassetti CL. Longitudinal polysomnographic assessment from acute to subacute phase in infratentorial versus supratentorial stroke. Cerebrovasc Dis. 2014;37(2):85-93. doi: 10.1159/000356323. Epub 2014 Jan 16.
Cereda CW, Petrini L, Azzola A, Ciccone A, Fischer U, Gallino A, Gyorik S, Gugger M, Mattis J, Lavie L, Limoni C, Nobili L, Manconi M, Ott S, Pons M, Bassetti CL. Sleep-disordered breathing in acute ischemic stroke and transient ischemic attack: effects on short- and long-term outcome and efficacy of treatment with continuous positive airways pressure--rationale and design of the SAS CARE study. Int J Stroke. 2012 Oct;7(7):597-603. doi: 10.1111/j.1747-4949.2012.00836.x. Epub 2012 Jul 19.
Related Links
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provides financial support for the study
Other Identifiers
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320030-125069/1
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
EOC.NC.10.01
Identifier Type: -
Identifier Source: org_study_id
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