Consequences of Obstructive Sleep Apnea Syndrome (OSAS) After Ischemic Subtentorial Stroke.

June 7, 2018 updated by: University Hospital, Montpellier

Consequences of Obstructive Sleep Apnea Syndrome (OSAS) on the Outcome and the Survival After Ischemic Subtentorial Stroke. Impact of the Treatment With Continuous Positive Airway Pressure (CPAP)

Obstructive Sleep Apnea Syndrome (OSAS) is associated with stroke as a risk factor but little is known about the consequences of OSAS on the outcome and the survival after stroke. The aim of the investigators study is first to evaluate the outcome and the survival of patients with stroke depending of OSAS (presence and severity of OSAS) and second to compare the outcome and survival of patients with severe OSAS depending on the treatment of the syndrome with nocturnal continuous positive airway pressure. The investigators hypothesis is that OSAS is associated with worst survival and outcome and needs to be treated at the subacute phase of stroke.

Study Overview

Detailed Description

Objective : The aim of our study is to evaluate the consequences of obstructive sleep apnea syndrome on the functional outcome and the survival after an ischemic stroke and to measure the impact of the treatment with continuous positive airway pressure on the outcome of patients with severe obstructive sleep apnea syndrome.Patients and methods : We will prospectively explore by polysomnography, 300 consecutive patients hospitalized for an ischemic stroke in the stroke units of university hospitals at the sub acute phase after stroke (J15±4). 1) We will compare the functional outcome, the neurological impairment, the peripheral endothelial function, the continuous blood pressure measure on 24 hours recording, the quality of life and the survival at 3, 6 and 12 months in four groups of patients depending on their apnea/hypopnea index 2) In patients with severe obstructive sleep apnea syndrome, we will explore the impact on the functional outcome, the neurological impairment, and the survival at 3, 6 et 12 months of a treatment with continuous positive airway pressure (CPAP) randomly compared to a treatment with sham CPAP (non efficacious pressure) during 3 months. Conclusion : This study should allow us to evaluate the consequences of obstructive sleep apnea syndrome on the outcome and the survival after ischemic stroke and the impact and the tolerance of the treatment with continuous positive airway pressure in patients with severe obstructive sleep apnea syndrome.

Study Type

Interventional

Enrollment (Anticipated)

300

Phase

  • Not Applicable

Contacts and Locations

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

Study Contact

Study Locations

      • Montpellier, France, 34295
        • Recruiting
        • University Hospital of Montpellier
        • Contact:
          • Valérie Cochen De Cock

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

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Brain infarction confirmed by brain imaging

    • follow up possible
    • Severity at admission and at one week follow up:
  • NIHSS ≥ 4 or- isolated aphasia (item 9 ofNIHSS ≥ 1) or
  • negligence (item 11 du NIHSS ≥ 2) or
  • distal motor deficit (score ≥ 1)

    • Health insurance affiliation
    • Inform and free consent agreement

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: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: apnea/hypopnea index (AHI<5 : no OSAS)
No Intervention: apnea/hypopnea index (5≥AHI<15 : mild OSAS)
No Intervention: apnea/hypopnea index (15≤AHI<30 :moderate OSAS)
Active Comparator: apnea/hypopnea index ( AHI≥30 : severe OSAS treated).
Treated with CPAP
obstructive sleep apnea syndrome survival ischemic stroke continuous positive airway pressure handicap
Sham Comparator: apnea/hypopnea index ( AHI≥30:severe OSAS untreated).
Treated with sham CPAP (placebo)
inefficient Continuous Positivie Airway pressure

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
functional independence scale
Time Frame: 3 months
The variation of the functional independence scale is evaluated by the Barthel Index at three months after stroke in four groups of patients depending on their apnea/hypopnea.In the patients group severe OSAS treated with CPAP from day 15 after stroke compared to patients with severe OSAS treated with sham CPAPThe neurological dependency will be evaluated by the Barthel Index .This scale measures the consequences of the motor and cognitive disorders on the daily living with 10 items.
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
neurological impairment
Time Frame: 3 months

The variation of the neurological impairment (NIHSS score) at three months after stroke:

  • in four groups of patients depending on their apnea/hypopnea index
  • In the patients group with severe OSAS treated with CPAP from day 15 after stroke vs patients with severe OSAS treated with sham CPAP
3 months
the handicap
Time Frame: 3 months

the handicap (via the Rankin score ), at three months after stroke:

in four groups of patients depending on their apnea/hypopnea index In the patients group with severe OSAS treated with CPAP from day 15 after stroke vs patients with severe OSAS treated with sham CPAP

3 months
blood pressure
Time Frame: 3 months

The continuous measure of blood pressure over 24 hours at three months after stroke:

in four groups of patients depending on their apnea/hypopnea index In the patients group with severe OSAS treated with CPAP from day 15 after stroke vs patients with severe OSAS treated with sham CPAP

3 months
the quality of life
Time Frame: 3 months

the quality of life (SF-36) at three months after stroke:

in four groups of patients depending on their apnea/hypopnea index In the patients group with severe OSAS treated with CPAP from day 15 after stroke vs patients with severe OSAS treated with sham CPAP

3 months
the survival
Time Frame: 3 months

the survival at three months after stroke:

in four groups of patients depending on their apnea/hypopnea index In the patients group with severe OSAS treated with CPAP from day 15 after stroke vs patients with severe OSAS treated with sham CPAP

3 months

Collaborators and Investigators

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

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 (Actual)

September 1, 2011

Primary Completion (Anticipated)

March 1, 2019

Study Completion (Anticipated)

December 1, 2020

Study Registration Dates

First Submitted

March 6, 2012

First Submitted That Met QC Criteria

March 21, 2012

First Posted (Estimate)

March 23, 2012

Study Record Updates

Last Update Posted (Actual)

June 11, 2018

Last Update Submitted That Met QC Criteria

June 7, 2018

Last Verified

June 1, 2018

More Information

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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