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

October 23, 2015 updated by: Prof. Claudio Bassetti

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

246

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Münster, Germany
        • University Hospital Münster
  • Italy
    • Lombardia
      • Milan, Lombardia, Italy, I-20162
        • Dipartimento Neuroscienze, Ospedale Niguarda
  • Switzerland
      • Bern, Switzerland, CH-3010
        • Inselspital, Universitätsklinik für Pneumologie
    • Ticino
      • Bellinzona, Ticino, Switzerland, CH-6500
        • Ospedale San Giovanni
      • Lugano, Ticino, Switzerland, CH-6900
        • Neurocenter of Southern Switzerland, Ospedale Civico

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

35 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
24 monts after stroke

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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
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).
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
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).
up to 12 months after stroke

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Prof. Claudio Bassetti

Collaborators

Swiss National Science Foundation
ResMed
Philips Respironics
Schweizerische Herzstiftung

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2010

Primary Completion (Anticipated)

April 1, 2016

Study Completion (Anticipated)

April 1, 2016

Study Registration Dates

First Submitted

April 1, 2010

First Submitted That Met QC Criteria

April 1, 2010

First Posted (Estimate)

April 2, 2010

Study Record Updates

Last Update Posted (Estimate)

October 26, 2015

Last Update Submitted That Met QC Criteria

October 23, 2015

Last Verified

October 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EOC.NC.10.01
  • 320030-125069/1 (Other Grant/Funding Number: Swiss National Science Foundation (SNSF))

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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