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| Name | Class |
|---|---|
| Fundação de Amparo à Pesquisa do Estado de São Paulo | OTHER_GOV |
| ResMed Foundation | OTHER |
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The study aims to evaluate whether early treatment of obstructive sleep apnea with continuous positive airway pressure in ischemic stroke patients has a favorable effect on functional recovery.
Obstructive sleep apnea (OSA) is present in more than 70% of acute stroke patients, and has been related to poor short-and long-term outcomes. The treatment of choice for OSA is continuous positive airway pressure (CPAP).
The objective of this prospective, multicenter, randomized study is to evaluate the impact of CPAP treatment on clinical outcomes in post-stroke patients. Respiratory polygraphy will be performed in all eligible participants, and those with severe OSA will be randomized to receive either CPAP therapy or conservative management. CPAP use will initiated within the first 48-72 hours of hospital admission and continued through 2 years follow-up.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Severe OSA treated | Active Comparator | AHI≥30: treated with CPAP |
|
| Severe OSA untreated | No Intervention | AHI≥30: without CPAP | |
| No OSA | No Intervention | AHI<5 | |
| Mild OSA | No Intervention | 5≥AHI<15 | |
| Moderate OSA | No Intervention | 15≤AHI<30 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CPAP | Device | Automatically-adjusting continuous positive airway pressure (CPAP) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Functional disability | Measured by the modified Rankin Scale, ranging from 0 (no symptoms) to 6 (death), with higher scores indicating greater disability and dependence on daily activities. | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Neurological impairment | Stroke severity will be measured by National Institutes of Health Stroke Scale, which ranges from 0 to 42, with higher scores reflecting greater neurological impairment. Neurological deterioration was defined as an increase of 4 or more points on the NIH Stroke Scale within 72 hours after stroke onset | Admission, 72 hours, day 5/discharge, 3 months, and 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Millene Camilo, MD, PhD | Contact | +55-16-36059075 | millene.camilo@fmrp.usp.br |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital das Clínicas, Ribeirão Preto Medical School, University of São Paulo | Recruiting | Ribeirão Preto | São Paulo | 14015-130 | Brazil |
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| ID | Term |
|---|---|
| D000083242 | Ischemic Stroke |
| D020181 | Sleep Apnea, Obstructive |
| D020521 | Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| Functional independence | Measured by the modified Rankin Scale (dichotomized analysis with mRS ≤ 2) and the Barthel Index, which ranges from 0 (worst, fully dependent) to 100 (best, independent). | Day 5/discharge, 3 months, 6 months, 1 year, and 2 years |
| Cognitive impairment | Evaluated through the Montreal Cognitive Assessment, which was developed as a brief screening instrument for mild cognitive impairment. It assesses different cognitive domains, scoring up to 30. | Day 5/discharge, 3 months, 1 year, and 2 years |
| Subjective quality of life | Measured by the EuroQol-5 Dimension (no problems = 1; some problems = 2; and extreme problems or unable to = 3). | Day 5/discharge, 3 months, 6 months, 1 year, and 2 years |
| Depressive episode | Assessed using the MINI-International Neuropsychiatric Interview, which is a structured interview to assess symptoms related to depression. Questions are phrased to allow only "yes" or "no" answers. | Day 5/discharge, 3 months, 1 year, and 2 years |
| Excessive daytime sleepiness | Assessed using the Epworth Sleepiness Scale. The total score, calculated by adding up the values of each answer, ranges from 0 to 24. A score of 10 or higher indicates excessive daytime sleepiness. | Admission, 3 months, 6 months, 1 year, and 2 years |
| Mortality | Mortality resulting from any cause will be recorded throughout the study. | 2 years |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D012891 | Sleep Apnea Syndromes |
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |