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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Swiss National Science Foundation
Schweizerische Herzstiftung
ResMed
Philips Respironics
Information provided by (Responsible Party):
Prof. Claudio Bassetti, Ospedale Civico, Lugano
ClinicalTrials.gov Identifier:
NCT01097967
First received: April 1, 2010
Last updated: October 23, 2015
Last verified: October 2015
  Purpose
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.

Condition Intervention Phase
TIA
Ischemic Stroke
Other: CPAP
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Sleep Disordered Breathing in TIA/Ischemic Stroke: Effects on Short- and Long-term Outcome and CPAP Treatment Efficacy: an Open, Observational, Clinical, Multicentre Trial With a Randomized Arm

Resource links provided by NLM:


Further study details as provided by Ospedale Civico, Lugano:

Primary Outcome Measures:
  • Occurence of new vascular events or death in stroke survivors (myocardial infarction, stroke, death) assessed by telephone or reported [ Time Frame: 24 monts after stroke ] [ Designated as safety issue: No ]
    New vascular events will be assessed by regular telephone interviews at 6,12 and 24 months after stroke


Secondary Outcome Measures:
  • CPAP-Compliance measured by hours of usage [ Time Frame: up to 24 months after stroke ] [ Designated as safety issue: No ]
    Compliance is monitored for the use of the CPAP by the pulmonary specialist at the patients' routine visits 2-3, 4-6 weeks, 3-6 months, 12 and 24 months after randomisation. The hours ofuse are registered by a chip inserted in the device. Good compliance is, if the device was used > 10 hours per day. Satisfactory compliance is defined for a use of the CPAP for at least 4 hours per night during at least 70% of the nights. Insufficient compliance is defined as < 4 hours per night or less than 70% of nights.

  • 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 [ Time Frame: up to 12 months after stroke ] [ Designated as safety issue: No ]
    Mean systolic and diastolic BP values, minimal and maximum values will be calculated for each patient for each period of time [after stroke: whole measuring period, (36 h) first night, second day, and second night after stroke; 3 months after stroke: whole period (24 h), day, night]. In addition same measurements will be made 12 months after stroke The occurrence of dippers will be registered at baseline (after stroke) and at 3 months. A dipper is defined, if the mean pressure at night is diminished more than 10% (compared to day data). An inverse-dipper is defined if more than 10% augmentation of night pressure will be registered. A deep-deeper is defined the mean pressure at night is diminished more than 20% (compared to day data).

  • Blood pressure dipping measured by ambulatory 24h-BP-devices in the acute stroke phase, after 3 months and after 12 months [ Time Frame: up to 12 months after stroke ] [ Designated as safety issue: No ]
    The occurrence of dippers will be registered at baseline (after stroke) and at 3 months and 12 months after stroke. A dipper is defined, if the mean pressure at night is diminished more than 10% (compared to day data). An inverse-dipper is defined if more than 10% augmentation of night pressure will be registered. A deep-deeper is defined the mean pressure at night is diminished more than 20% (compared to day data).


Enrollment: 246
Study Start Date: July 2010
Estimated Study Completion Date: April 2016
Estimated Primary Completion Date: April 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: CPAP in sleepy patients with SDB
SDB defined as AHI >=20 Sleepy defined as Epworth Sleepiness Score >=10
Other: CPAP
No Intervention: no CPAP in non sleepy patients with SDB
SDB defined as AHI >=20 Sleepy defined as Epworth Sleepiness Score >=10
Active Comparator: CPAP in non sleepy patients with SDB
SDB defined as AHI >=20 Sleepy defined as Epworth Sleepiness Score >=10
Other: CPAP

Detailed Description:

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.

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.

  Eligibility

Ages Eligible for Study:   35 Years to 75 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • ≥ 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

Exclusion Criteria:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01097967

Locations
Germany
University Hospital Münster
Münster, Germany
Italy
Dipartimento Neuroscienze, Ospedale Niguarda
Milan, Lombardia, Italy, I-20162
Switzerland
Ospedale San Giovanni
Bellinzona, Ticino, Switzerland, CH-6500
Neurocenter of Southern Switzerland, Ospedale Civico
Lugano, Ticino, Switzerland, CH-6900
Inselspital, Universitätsklinik für Pneumologie
Bern, Switzerland, CH-3010
Sponsors and Collaborators
Prof. Claudio Bassetti
Swiss National Science Foundation
Schweizerische Herzstiftung
ResMed
Philips Respironics
Investigators
Principal Investigator: Claudio Bassetti, Professor Universitätsspital Bern (Inselspital) und Universität Bern
Study Chair: 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
  More Information

Additional Information:
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Prof. Claudio Bassetti, Dr. med. Claudio Bassetti, Ospedale Civico, Lugano
ClinicalTrials.gov Identifier: NCT01097967     History of Changes
Other Study ID Numbers: EOC.NC.10.01  320030-125069/1 
Study First Received: April 1, 2010
Last Updated: October 23, 2015
Health Authority: Switzerland: Ethikkomission

Keywords provided by Ospedale Civico, Lugano:
Sleep disordered breathing
Continuous Positive Airway Pressure
Sleep apnoea
Markers of atherosclerosis

Additional relevant MeSH terms:
Stroke
Ischemia
Cerebral Infarction
Respiratory Aspiration
Ischemic Attack, Transient
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Pathologic Processes
Brain Infarction
Brain Ischemia
Respiration Disorders
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on September 27, 2016