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RECRUITINGINTERVENTIONAL

Obstructive Sleep Apnea Treatment From Acute to Chronic Phase of Stroke

Obstructive Sleep Apnea Treatment From Acute to Chronic Phase of Stroke - A Randomized Clinical Trial

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - Supratentorial non-lacunar ischemic stroke, including anterior, middle, and posterior cerebral artery territories - Aged 18 to 80 years - Symptom onset or symptom recognition to admission \< 12 hours - NIHSS score ≥ 4 and ≤ 20 at enrollment - Signed willing to sign a consent form form obtained from the participant or their legal representative Who Should NOT Join This Trial: - Prior stroke - Previous diagnosis of OSA with current CPAP use or previously failed CPAP - Pre-stroke disability (mRS \> 1) - Coma or stupor - Orotracheal intubation - Clinical instability or severe pre-existing illness (e.g., heart failure, oxygen-dependent COPD, renal or hepatic failure) - Psychomotor agitation - High likelihood of neurosurgical intervention within the first 48 hours - Oxygen therapy \>2 L/min - Known severe neurological disease (e.g., dementia, Parkinson's disease, multiple sclerosis, or other neurodegenerative conditions) - Chronic alcohol or drug use with high risk of withdrawal during hospitalization - Pregnant or suspected pregnant women - Inability to complete follow-up for any reason - Any contraindication to CPAP use Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: * Supratentorial non-lacunar ischemic stroke, including anterior, middle, and posterior cerebral artery territories * Aged 18 to 80 years * Symptom onset or symptom recognition to admission \< 12 hours * NIHSS score ≥ 4 and ≤ 20 at enrollment * Signed informed consent form obtained from the participant or their legal representative Exclusion Criteria: * Prior stroke * Previous diagnosis of OSA with current CPAP use or previously failed CPAP * Pre-stroke disability (mRS \> 1) * Coma or stupor * Orotracheal intubation * Clinical instability or severe pre-existing illness (e.g., heart failure, oxygen-dependent COPD, renal or hepatic failure) * Psychomotor agitation * High likelihood of neurosurgical intervention within the first 48 hours * Oxygen therapy \>2 L/min * Known severe neurological disease (e.g., dementia, Parkinson's disease, multiple sclerosis, or other neurodegenerative conditions) * Chronic alcohol or drug use with high risk of withdrawal during hospitalization * Pregnant or suspected pregnant women * Inability to complete follow-up for any reason * Any contraindication to CPAP use

Treatments Being Tested

DEVICE

CPAP

Automatically-adjusting continuous positive airway pressure (CPAP)

Locations (1)

Hospital das Clínicas, Ribeirão Preto Medical School, University of São Paulo
Ribeirão Preto, São Paulo, Brazil