Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01097967
Recruitment Status : Unknown
Verified October 2015 by Prof. Claudio Bassetti, Ospedale Civico, Lugano.
Recruitment status was:  Active, not recruiting
First Posted : April 2, 2010
Last Update Posted : October 26, 2015
Sponsor:
Collaborators:
Swiss National Science Foundation
Schweizerische Herzstiftung
ResMed
Philips Respironics
Information provided by (Responsible Party):
Prof. Claudio Bassetti, Ospedale Civico, Lugano

Tracking Information
First Submitted Date  ICMJE April 1, 2010
First Posted Date  ICMJE April 2, 2010
Last Update Posted Date October 26, 2015
Study Start Date  ICMJE July 2010
Estimated Primary Completion Date April 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 23, 2015)
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 ]
New vascular events will be assessed by regular telephone interviews at 6,12 and 24 months after stroke
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 23, 2015)
  • CPAP-Compliance measured by hours of usage [ Time Frame: up to 24 months after stroke ]
    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 ]
    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 ]
    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).
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Sleep Disordered Breathing in Transient Ischemic Attack (TIA)/Ischemic Stroke and Continuous Positive Airway Pressure (CPAP) Treatment Efficacy
Official Title  ICMJE 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
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.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE
  • TIA
  • Ischemic Stroke
Intervention  ICMJE Other: CPAP
Study Arms  ICMJE
  • Active Comparator: CPAP in sleepy patients with SDB
    SDB defined as AHI >=20 Sleepy defined as Epworth Sleepiness Score >=10
    Intervention: 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
    Intervention: Other: CPAP
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Actual Enrollment  ICMJE
 (submitted: October 23, 2015)
246
Original Estimated Enrollment  ICMJE
 (submitted: April 1, 2010)
1000
Estimated Study Completion Date  ICMJE April 2016
Estimated Primary Completion Date April 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 35 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany,   Italy,   Switzerland
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01097967
Other Study ID Numbers  ICMJE EOC.NC.10.01
320030-125069/1 ( Other Grant/Funding Number: Swiss National Science Foundation (SNSF) )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Prof. Claudio Bassetti, Ospedale Civico, Lugano
Study Sponsor  ICMJE Prof. Claudio Bassetti
Collaborators  ICMJE
  • Swiss National Science Foundation
  • Schweizerische Herzstiftung
  • ResMed
  • Philips Respironics
Investigators  ICMJE
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
PRS Account Ospedale Civico, Lugano
Verification Date October 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP