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)

This study is currently recruiting participants.
Verified March 2012 by University Hospital, Montpellier
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

March 6, 2012
March 21, 2012
September 2011
March 2014   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01561677 on ClinicalTrials.gov Archive Site
  • 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

Same as current
Not Provided
Not Provided
 
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)
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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Supportive Care
  • Obstructive Sleep Apnea Syndrome
  • Brain Infarction
  • Device: Continuous Positive Airway pressure-RESPIRONICS
    obstructive sleep apnea syndrome survival ischemic stroke continuous positive airway pressure handicap
  • Device: Sham Continuous Positive Airway pressure-RESPIRONICS
    inefficient Continuous Positivie Airway pressure
  • 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
    Intervention: Device: Continuous Positive Airway pressure-RESPIRONICS
  • Sham Comparator: apnea/hypopnea index ( AHI≥30:severe OSAS untreated).
    Treated with sham CPAP (placebo)
    Intervention: Device: Sham Continuous Positive Airway pressure-RESPIRONICS
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
300
Not Provided
March 2014   (final data collection date for primary outcome measure)

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
Both
18 Years to 85 Years
No
Contact: Valérie Cochen De Cock, MD-PhD VALERIE.COCHEN@GMAIL.COM
France
 
NCT01561677
UF8670
No
University Hospital, Montpellier
University Hospital, Montpellier
Not Provided
Not Provided
University Hospital, Montpellier
March 2012

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