Effect Of Early C-PAP Treatment For Sleep Apnea On Rehabilitation Of Stroke Patients
Primary Purpose
Sleep Apnea, Stroke
Status
Withdrawn
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Watchpat
CPAP
Sponsored by
About this trial
This is an interventional treatment trial for Sleep Apnea focused on measuring c-PAP
Eligibility Criteria
Inclusion Criteria:
- Patients over the age of 18.
- Admitted to the Neurology Department due to acute ischemic stroke.
- Able to sign informed consent.
- Admission NIHSS 6-12.
Exclusion Criteria:
- Stroke symptom onset more than 72 hours prior to the enrollment
- Transient Ischemic Attack.
- Chronic pulmonary disease requiring home oxygen treatment.
- History of C-PAP treatment
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Investigatory 1
Investigatory 2
Arm Description
The sleep study will be performed via Watchpat during the index hospitalization with acute stroke. Following the diagnosis of sleep apnea, patients will be treated with C-PAP both during the hospital stay and after discharge for three months.
The sleep study will be performed via Watchpat at home three months after hospitalization with acute stroke. Following the diagnosis of sleep apnea, patients will be treated with C-PAP for three months.
Outcomes
Primary Outcome Measures
NIHSS change from the baseline to 3 months
Change in the NIHSS score from admission to three months
Secondary Outcome Measures
NIHSS change score from admission to discharge from the Neurology Department.
NIHSS score change from admission to 6 months following hospitalization
NIHSS score change from three to six months following hospitalization
Prevent recurrent strokes at 6 months
Analyse the composite of cardiovascular events at 6 months (acute myocardial infarction, coronary revascularization, death or recurrent stroke)
Evaluate new MRI ischemic lesions between 3 MRI scans.
Change Epworth Sleepiness Scale (ESS) at 3 and 6 months from the baseline
Change quality of life (SF36) at 3 and 6 months from the baseline
Change depression scale (Beck) at 3 and 6 months from the baseline
Change number of severe adverse events (SAE) at 3 months
Full Information
NCT ID
NCT02426424
First Posted
December 24, 2014
Last Updated
April 17, 2018
Sponsor
Soroka University Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT02426424
Brief Title
Effect Of Early C-PAP Treatment For Sleep Apnea On Rehabilitation Of Stroke Patients
Official Title
Effect Of Early C-PAP Treatment For Sleep Apnea On Rehabilitation Of Stroke Patients
Study Type
Interventional
2. Study Status
Record Verification Date
April 2018
Overall Recruitment Status
Withdrawn
Why Stopped
Failure to have funding to perform the trial
Study Start Date
January 2018 (Anticipated)
Primary Completion Date
June 2020 (Anticipated)
Study Completion Date
December 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Soroka University Medical Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This is a prospective randomized open label trial with control-to-treatment cross-over. The investigators wish to assess the effectiveness and safety of immediate detection and treatment for Sleep Apnea in Stroke patients. The investigators hypothesize that in patients with acute ischemic stroke a sleep apnea treatment by CPAP will result in a better neurological outcome and more successful rehabilitation.
The study will enroll 140 subjects which will be randomized into one of two arms:
Investigational - The sleep study will be performed during the index hospitalization with acute stroke. Following the diagnosis of sleep apnea, patients will be treated with C-PAP both during the hospital stay and after discharge.
Control group -Will receive standard medical care. Patients will undergo sleep study at 3 months following discharge and patients diagnosed with sleep apnea will be treated with C-PAP.
Detailed Description
Patients eligible to be enrolled in this study are patients admitted to the Department of Neurology due to acute ischemic stroke up to 72 hours from the start of the stroke symptoms.
After receiving written informed consent from the patient, patients will be randomized into the intervention and control groups (1:1). The intervention group will be tested for sleep apnea and C-PAP treatment will be initiated during the initial hospitalization. The control group will receive standard medical care. Control group patients will undergo sleep study at 3 months following discharge and patients diagnosed with sleep apnea will be treated with C-PAP.
All subjects:
At the baseline, physical examination MRS and NIHSS will be performed by the neurologist.
Sleep testing at the baseline with mobile sleep lab device (Watch PAT)
Four questionnaires will be administered for all patients: Epworth Sleepiness Scale (ESS), Pittsburgh Sleep Quality Index (PSQI), quality of life (SF36), depression scale (Beck).
Blood sample will be taken for CRP, TNF-alpha, IL-6 and IL1 beta, VEGF, HBA1C, LDL and markers of endothelial dysfunction. These blood tests will be repeated at 3 and 6 months.
At discharge from the Neurology Department, 3 months and 6 months all patients will undergo NIHSS assessment.
Patients will be referred to the Soroka stroke clinic with rehabilitation program.
All patients will undergo 3 brain MRI scans, at baseline hospitalization, 3 and 6 months after.
Intervention group:
In the intervention group, the mobile sleep lab device (Watch PAT) will be used to identify patients with sleep apnea.
Treatment phase: Patients with (apnea hypopnea index) AHI≥15 will receive an in-hospital treatment with CPAP and continue CPAP treatment following discharge. The CPAP parameters will be titrated during the hospital stay.
Control group:
Patients will receive standard medical care. At three months, patients will undergo home sleep test with Watch-PAT device.
Patients with (apnea hypopnea index) AHI≥15 will receive CPAP treatment with titration at home.
TRIAL PROCEDURES 1. Patients eligible to be enrolled in this study are patients admitted to the Neurology Department due to stroke up to 72 hours after the showing of stroke symptoms.
2. At the baseline, physical examination, MRS and NIHSS will be performed by one of the Neurology Department doctors.
3. After receiving written informed consent from the patient, patients will be divided into 2 groups. Study group will have detection and treatment in 72 hours after stroke. Control group will have detection and treatment 3 months after stroke.
STUDY AND CONTROL GROUP
The patient will answer four questionnaires: Epworth Sleepiness Scale (ESS), Pittsburgh Sleep Quality Index (PSQI), "quality of life" (SF36) and "depression scale" (beck).
Next, the mobile sleep lab device (Watch PAT) will be placed on the patient's finger which will provide the apnea-hypopnea Index (AHI) and respiratory disturbance index (RDI).
Blood samples for circulating inflammatory biomarkers and endothelial dysfunction will be performed in the morning. Four tubes of peripheral venous blood will be drawn. Every study patient will be tested for the presence of pro-inflammatory state. Specifically, the investigators will measure the presence of high sensitive C Reactive Protein (CRP) and centrifuged sera will be tested (by ultra- sensitive ELISA), for levels of circulating TNF-alpha, IL-6 and IL1 beta. Sera will also be tested for vascular endothelial growth factor (VEGF) and markers of endothelial dysfunction; P-selectin. LDL, HBA1C.
At discharge from the Neurology Department, the patient will undergo NIHSS assessment.
Half of patients randomly chosen will be asked to join an "early treatment" group for 6 months of C-PAP treatment. Patients from the other half will be asked for C-PAP treatment at 3 months (late intervention).
All four questionnaires will be completed by all patients at the end of the follow up period.
MRI scan will be done at three points: CVA admission, 3 and 6 months after.
Six months after baseline hospitalization, patients from both groups will answer four questionnaires: Epworth Sleepiness Scale (ESS), Pittsburgh Sleep Quality Index (PSQI), "quality of life" (SF36) and "depression scale" (beck).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep Apnea, Stroke
Keywords
c-PAP
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Investigatory 1
Arm Type
Experimental
Arm Description
The sleep study will be performed via Watchpat during the index hospitalization with acute stroke. Following the diagnosis of sleep apnea, patients will be treated with C-PAP both during the hospital stay and after discharge for three months.
Arm Title
Investigatory 2
Arm Type
Experimental
Arm Description
The sleep study will be performed via Watchpat at home three months after hospitalization with acute stroke. Following the diagnosis of sleep apnea, patients will be treated with C-PAP for three months.
Intervention Type
Device
Intervention Name(s)
Watchpat
Intervention Description
WatchPAT ™ is an FDA-approved portable diagnostic device that uses the most innovative technology to ensure the accurate screening, detection, and the follow-up treatment of sleep apnea.
Intervention Type
Device
Intervention Name(s)
CPAP
Intervention Description
Continuous positive airway pressure (CPAP) is a form of positive airway pressure ventilator, which applies mild air pressure on a continuous basis to keep the airways continuously open in a patient who is able to breathe spontaneously on his or her own.
Primary Outcome Measure Information:
Title
NIHSS change from the baseline to 3 months
Description
Change in the NIHSS score from admission to three months
Time Frame
3 months
Secondary Outcome Measure Information:
Title
NIHSS change score from admission to discharge from the Neurology Department.
Time Frame
3 months
Title
NIHSS score change from admission to 6 months following hospitalization
Time Frame
6 months
Title
NIHSS score change from three to six months following hospitalization
Time Frame
6 month
Title
Prevent recurrent strokes at 6 months
Time Frame
6 months
Title
Analyse the composite of cardiovascular events at 6 months (acute myocardial infarction, coronary revascularization, death or recurrent stroke)
Time Frame
6 months
Title
Evaluate new MRI ischemic lesions between 3 MRI scans.
Time Frame
6 months
Title
Change Epworth Sleepiness Scale (ESS) at 3 and 6 months from the baseline
Time Frame
6 months
Title
Change quality of life (SF36) at 3 and 6 months from the baseline
Time Frame
6 months
Title
Change depression scale (Beck) at 3 and 6 months from the baseline
Time Frame
6 months
Title
Change number of severe adverse events (SAE) at 3 months
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients over the age of 18.
Admitted to the Neurology Department due to acute ischemic stroke.
Able to sign informed consent.
Admission NIHSS 6-12.
Exclusion Criteria:
Stroke symptom onset more than 72 hours prior to the enrollment
Transient Ischemic Attack.
Chronic pulmonary disease requiring home oxygen treatment.
History of C-PAP treatment
12. IPD Sharing Statement
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Effect Of Early C-PAP Treatment For Sleep Apnea On Rehabilitation Of Stroke Patients
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