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
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