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

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ClinicalTrials.gov Identifier: NCT01561677
Recruitment Status : Unknown
Verified June 2018 by University Hospital, Montpellier.
Recruitment status was:  Recruiting
First Posted : March 23, 2012
Last Update Posted : June 11, 2018
Sponsor:
Information provided by (Responsible Party):
University Hospital, Montpellier

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Obstructive Sleep Apnea Syndrome Brain Infarction Device: Continuous Positive Airway pressure-RESPIRONICS Device: Sham Continuous Positive Airway pressure-RESPIRONICS Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Supportive Care
Official Title: 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)
Actual Study Start Date : September 2011
Estimated Primary Completion Date : March 2019
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sleep Apnea

Arms and Interventions
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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
 Device: Continuous Positive Airway pressure-RESPIRONICS
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)
 Device: Sham Continuous Positive Airway pressure-RESPIRONICS
inefficient Continuous Positivie Airway pressure


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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

  2. 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. 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


  4. 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


  5. 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



Eligibility Criteria
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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01561677


Contacts
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Contact: Yves DAUVILLIERS, MD-PhD y-dauvilliers@chu-montpellier.fr

Locations
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France
University Hospital of Montpellier Recruiting
Montpellier, France, 34295
Contact: Valérie Cochen De Cock         
Sponsors and Collaborators
University Hospital, Montpellier
More Information
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Responsible Party: University Hospital, Montpellier
ClinicalTrials.gov Identifier: NCT01561677    
Other Study ID Numbers: 8670
First Posted: March 23, 2012    Key Record Dates
Last Update Posted: June 11, 2018
Last Verified: June 2018
Keywords provided by University Hospital, Montpellier:
obstructive sleep apnea
syndrome survival
ischemic stroke
continuous positive airway pressure
handicap
Additional relevant MeSH terms:
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Apnea
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Brain Infarction
Syndrome
Infarction
Disease
Pathologic Processes
Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
 Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Ischemia
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Necrosis
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Brain Ischemia