Sleep Disordered Breathing in Transient Ischemic Attack (TIA)/Ischemic Stroke and Continuous Positive Airway Pressure (CPAP) Treatment Efficacy

NCT01097967 | Unknown Phase 4

• 2 other identifiers: EOC.NC.10.01320030-125069/1
• Study Type: interventional
• Target: 246
• Locations: 3 countries
• Sites: 5

Brief Summary

The study aims to observe the short term effect (3-month) of sleep disordered breathing (SDB) on cardiovascular parameters, heart rate variability, endothelial function and surrogate markers of atherosclerosis after acute cerebrovascular events (ACE). The long-term effect (6-24-month) of Continuous Positive Airway Pressure (CPAP) on clinical vascular outcome, cardiovascular parameters, evolution of surrogate of atherosclerosis heart rate variability and endothelial function after ACE is observed over 24 months. A preventive effect of CPAP therapy on cerebro-vascular events in patients with moderate-severe obstructive SDB without sleepiness after ictus or transient ischaemic attack will be evaluated.

Conditions

TIA; Ischemic Stroke

Keywords

Sleep disordered breathing; Continuous Positive Airway Pressure; Sleep apnoea; Markers of atherosclerosis

Outcome Measures

Primary Outcomes (1)

• Occurence of new vascular events or death in stroke survivors (myocardial infarction, stroke, death) assessed by telephone or reported

  New vascular events will be assessed by regular telephone interviews at 6,12 and 24 months after stroke

  24 monts after stroke

Secondary Outcomes (3)

• CPAP-Compliance measured by hours of usage

  up to 24 months after stroke

• Blood pressure profile (systolic mean, diastolic mean, max, min: general, day, night) measured in mmHg for every patient by ambulatory 24h-BP-devices in the acute stroke phase, after 3 months and after 12 months

  up to 12 months after stroke

• Blood pressure dipping measured by ambulatory 24h-BP-devices in the acute stroke phase, after 3 months and after 12 months

  up to 12 months after stroke

Study Arms (3)

CPAP in sleepy patients with SDB

ACTIVE COMPARATOR

SDB defined as AHI \>=20 Sleepy defined as Epworth Sleepiness Score \>=10

Other: CPAP

no CPAP in non sleepy patients with SDB

NO INTERVENTION

SDB defined as AHI \>=20 Sleepy defined as Epworth Sleepiness Score \>=10

CPAP in non sleepy patients with SDB

ACTIVE COMPARATOR

SDB defined as AHI \>=20 Sleepy defined as Epworth Sleepiness Score \>=10

Other: CPAP

Interventions

CPAP OTHER

CPAP in non sleepy patients with SDB; CPAP in sleepy patients with SDB

Eligibility Criteria

• Age: 35 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥ 35 years old and \< 75 years old
• 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

You may not qualify if:

• with unstable clinical situation (cardio-respiratory or life-threatening medical conditions)
• 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

Sponsors & Collaborators

• Prof. Claudio Bassetti: lead
• Swiss National Science Foundation: collaborator
• Schweizerische Herzstiftung: collaborator
• ResMed: collaborator
• Philips Respironics: collaborator

Study Sites (5)

University Hospital Münster

Münster, Germany

Location

Dipartimento Neuroscienze, Ospedale Niguarda

Milan, Lombardy, I-20162, Italy

Location

Inselspital, Universitätsklinik für Pneumologie

Bern, Canton of Bern, CH-3010, Switzerland

Location

Ospedale San Giovanni

Bellinzona, Canton Ticino, CH-6500, Switzerland

Location

Neurocenter of Southern Switzerland, Ospedale Civico

Lugano, Canton Ticino, CH-6900, Switzerland

Location

Related Publications (8)

• 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.

  PMID: 8909424 BACKGROUND

• 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.

  PMID: 10201066 BACKGROUND

• 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.

  PMID: 15781100 BACKGROUND

• 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.

  PMID: 16543515 BACKGROUND

• 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.

  PMID: 19406983 BACKGROUND

• 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.

  PMID: 30032306 DERIVED

• 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.

  PMID: 24435018 DERIVED

• 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.

  PMID: 22812731 DERIVED

Related Links

• Click here to see more information about our hospital
• provides financial support for the study

MeSH Terms

Conditions

Ischemic Stroke; Sleep Apnea Syndromes

Condition Hierarchy (Ancestors)

Stroke; 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

Study Officials

• Claudio Bassetti, Professor

  Universitätsspital Bern (Inselspital) und Universität Bern

  PRINCIPAL INVESTIGATOR

• Carlo Cereda, Capo CLinica

  Neurocentre of Southern Switzerland, Ospedale Civico

  STUDY CHAIR

• Sebastian Ott, MD

  Pneumology, University Hospital, Bern

  STUDY CHAIR

• Lino Nobili, Prof. MD

  Neurology, Stroke Unit, Ospedale Niguarda, Milan, Italy

  STUDY CHAIR

• Mauro Manconi, MD

  Neurocentre of Southern Switzerland, Ospedale Civico

  STUDY CHAIR

• Peter Young, Prof. MD

  Universitätsklinik Münster, Zentrum für Schlafmedizin

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Dr. med. Claudio Bassetti

Study Record Dates

• First Submitted: April 1, 2010
• First Posted: April 2, 2010
• Study Start: July 1, 2010
• Primary Completion: April 1, 2016
• Study Completion: April 1, 2016
• Last Updated: October 26, 2015

Record last verified: 2015-10

Locations

IT (1); CH (3); DE (1)