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

Not Applicable

• Conditions: Obstructive Sleep Apnea Syndrome; Brain Infarction
• Interventions: Device: Continuous Positive Airway pressure-RESPIRONICS; Device: Sham Continuous Positive Airway pressure-RESPIRONICS

• Registration Number: NCT01561677
• Lead Sponsor: University Hospital, Montpellier

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.

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 Timeline

• Study Start: 2011-09
• Study First Submitted: 2012-03-06
• Study First Submitted QC: 2012-03-21
• Study First Posted: 2012-03-23
• Status Verified: 2018-06
• Last Update Submitted: 2018-06-07
• Last Update Posted: 2018-06-11
• Primary Completion: 2019-03
• Study Completion: 2020-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 300

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

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
apnea/hypopnea index ( AHI≥30 : severe OSAS treated).	Continuous Positive Airway pressure-RESPIRONICS	Treated with CPAP
apnea/hypopnea index ( AHI≥30:severe OSAS untreated).	Sham Continuous Positive Airway pressure-RESPIRONICS	Treated with sham CPAP (placebo)

Primary Outcome Measures

Name	Time	Method
functional independence scale	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

Name	Time	Method
the quality of life	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
blood pressure	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
neurological impairment	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
the handicap	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
the survival	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

Trial Locations

Locations (1)

University Hospital of Montpellier; 🇫🇷 Montpellier, France