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)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2012 by University Hospital, Montpellier.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
University Hospital, Montpellier
ClinicalTrials.gov Identifier:
NCT01561677
First received: March 6, 2012
Last updated: March 21, 2012
Last verified: March 2012
  Purpose

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 Intervention
Obstructive Sleep Apnea Syndrome
Brain Infarction
Device: Continuous Positive Airway pressure-RESPIRONICS
Device: Sham Continuous Positive Airway pressure-RESPIRONICS

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
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)

Resource links provided by NLM:


Further study details as provided by University Hospital, Montpellier:

Primary Outcome Measures:
  • functional independence scale [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    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:
  • neurological impairment [ Time Frame: 3 months ] [ Designated as safety issue: No ]

    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

  • the handicap [ Time Frame: 3 months ] [ Designated as safety issue: No ]

    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


  • blood pressure [ Time Frame: 3 months ] [ Designated as safety issue: No ]

    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


  • the quality of life [ Time Frame: 3 months ] [ Designated as safety issue: No ]

    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


  • the survival [ Time Frame: 3 months ] [ Designated as safety issue: No ]

    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



Estimated Enrollment: 300
Study Start Date: September 2011
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01561677

Contacts
Contact: Valérie Cochen De Cock, MD-PhD VALERIE.COCHEN@GMAIL.COM

Locations
France
University Hospital of Montpellier Recruiting
Montpellier, France, 34295
Contact: Valérie Cochen De Cock         
Sponsors and Collaborators
University Hospital, Montpellier
  More Information

No publications provided

Responsible Party: University Hospital, Montpellier
ClinicalTrials.gov Identifier: NCT01561677     History of Changes
Other Study ID Numbers: UF8670
Study First Received: March 6, 2012
Last Updated: March 21, 2012
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by University Hospital, Montpellier:
obstructive sleep apnea
syndrome survival
ischemic stroke
continuous positive airway pressure
handicap

Additional relevant MeSH terms:
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Apnea
Infarction
Stroke
Brain Infarction
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Ischemia
Pathologic Processes
Necrosis
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders
Nervous System Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Brain Ischemia

ClinicalTrials.gov processed this record on April 16, 2014