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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-09-30

Study Completion Date

2020-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Obstructive Sleep Apnea Syndrome Brain Infarction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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apnea/hypopnea index (AHI<5 : no OSAS)

Group Type NO_INTERVENTION

No interventions assigned to this group

apnea/hypopnea index (5≥AHI<15 : mild OSAS)

Group Type NO_INTERVENTION

No interventions assigned to this group

apnea/hypopnea index (15≤AHI<30 :moderate OSAS)

Group Type NO_INTERVENTION

No interventions assigned to this group

apnea/hypopnea index ( AHI≥30 : severe OSAS treated).

Treated with CPAP

Group Type ACTIVE_COMPARATOR

Continuous Positive Airway pressure-RESPIRONICS

Intervention Type DEVICE

obstructive sleep apnea syndrome survival ischemic stroke continuous positive airway pressure handicap

apnea/hypopnea index ( AHI≥30:severe OSAS untreated).

Treated with sham CPAP (placebo)

Group Type SHAM_COMPARATOR

Sham Continuous Positive Airway pressure-RESPIRONICS

Intervention Type DEVICE

inefficient Continuous Positivie Airway pressure

Interventions

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Continuous Positive Airway pressure-RESPIRONICS

obstructive sleep apnea syndrome survival ischemic stroke continuous positive airway pressure handicap

Intervention Type DEVICE

Sham Continuous Positive Airway pressure-RESPIRONICS

inefficient Continuous Positivie Airway pressure

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No