Consequences of Obstructive Sleep Apnea Syndrome (OSAS) After Ischemic Subtentorial Stroke.
Primary Purpose
Obstructive Sleep Apnea Syndrome, Brain Infarction
Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Continuous Positive Airway pressure-RESPIRONICS
Sham Continuous Positive Airway pressure-RESPIRONICS
Sponsored by
About this trial
This is an interventional supportive care trial for Obstructive Sleep Apnea Syndrome focused on measuring obstructive sleep apnea, syndrome survival, ischemic stroke, continuous positive airway pressure, handicap
Eligibility 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
Sites / Locations
- University Hospital of MontpellierRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm Type
No Intervention
No Intervention
No Intervention
Active Comparator
Sham Comparator
Arm Label
apnea/hypopnea index (AHI<5 : no OSAS)
apnea/hypopnea index (5≥AHI<15 : mild OSAS)
apnea/hypopnea index (15≤AHI<30 :moderate OSAS)
apnea/hypopnea index ( AHI≥30 : severe OSAS treated).
apnea/hypopnea index ( AHI≥30:severe OSAS untreated).
Arm Description
Treated with CPAP
Treated with sham CPAP (placebo)
Outcomes
Primary Outcome Measures
functional independence scale
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
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
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
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
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
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
Full Information
NCT ID
NCT01561677
First Posted
March 6, 2012
Last Updated
June 7, 2018
Sponsor
University Hospital, Montpellier
1. Study Identification
Unique Protocol Identification Number
NCT01561677
Brief Title
Consequences of Obstructive Sleep Apnea Syndrome (OSAS) After Ischemic Subtentorial Stroke.
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)
Study Type
Interventional
2. Study Status
Record Verification Date
June 2018
Overall Recruitment Status
Unknown status
Study Start Date
September 2011 (Actual)
Primary Completion Date
March 2019 (Anticipated)
Study Completion Date
December 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Montpellier
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstructive Sleep Apnea Syndrome, Brain Infarction
Keywords
obstructive sleep apnea, syndrome survival, ischemic stroke, continuous positive airway pressure, handicap
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
300 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
apnea/hypopnea index (AHI<5 : no OSAS)
Arm Type
No Intervention
Arm Title
apnea/hypopnea index (5≥AHI<15 : mild OSAS)
Arm Type
No Intervention
Arm Title
apnea/hypopnea index (15≤AHI<30 :moderate OSAS)
Arm Type
No Intervention
Arm Title
apnea/hypopnea index ( AHI≥30 : severe OSAS treated).
Arm Type
Active Comparator
Arm Description
Treated with CPAP
Arm Title
apnea/hypopnea index ( AHI≥30:severe OSAS untreated).
Arm Type
Sham Comparator
Arm Description
Treated with sham CPAP (placebo)
Intervention Type
Device
Intervention Name(s)
Continuous Positive Airway pressure-RESPIRONICS
Intervention Description
obstructive sleep apnea syndrome survival ischemic stroke continuous positive airway pressure handicap
Intervention Type
Device
Intervention Name(s)
Sham Continuous Positive Airway pressure-RESPIRONICS
Intervention Description
inefficient Continuous Positivie Airway pressure
Primary Outcome Measure Information:
Title
functional independence scale
Description
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.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
neurological impairment
Description
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
Time Frame
3 months
Title
the handicap
Description
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
Time Frame
3 months
Title
blood pressure
Description
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
Time Frame
3 months
Title
the quality of life
Description
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
Time Frame
3 months
Title
the survival
Description
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
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yves DAUVILLIERS, MD-PhD
Email
y-dauvilliers@chu-montpellier.fr
Facility Information:
Facility Name
University Hospital of Montpellier
City
Montpellier
ZIP/Postal Code
34295
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Valérie Cochen De Cock
12. IPD Sharing Statement
Learn more about this trial
Consequences of Obstructive Sleep Apnea Syndrome (OSAS) After Ischemic Subtentorial Stroke.
We'll reach out to this number within 24 hrs