Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Failure to have funding to perform the trial
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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:
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:
Intervention group:
Control group:
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
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Investigatory 1 | Experimental | 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. |
|
| Investigatory 2 | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Watchpat | Device | WatchPAT â„¢ 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. |
| Measure | Description | Time Frame |
|---|---|---|
| NIHSS change from the baseline to 3 months | Change in the NIHSS score from admission to three months | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| NIHSS change score from admission to discharge from the Neurology Department. | 3 months | |
| NIHSS score change from admission to 6 months following hospitalization | 6 months | |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D012891 | Sleep Apnea Syndromes |
| D020521 | Stroke |
| ID | Term |
|---|---|
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D020919 | Sleep Disorders, Intrinsic |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| CPAP | Device | 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. |
|
| NIHSS score change from three to six months following hospitalization |
| 6 month |
| Prevent recurrent strokes at 6 months | 6 months |
| Analyse the composite of cardiovascular events at 6 months (acute myocardial infarction, coronary revascularization, death or recurrent stroke) | 6 months |
| Evaluate new MRI ischemic lesions between 3 MRI scans. | 6 months |
| Change Epworth Sleepiness Scale (ESS) at 3 and 6 months from the baseline | 6 months |
| Change quality of life (SF36) at 3 and 6 months from the baseline | 6 months |
| Change depression scale (Beck) at 3 and 6 months from the baseline | 6 months |
| Change number of severe adverse events (SAE) at 3 months | 3 months |
| D020920 |
| Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |