RecruitingNot ApplicableNCT07044830

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


Sponsor

Hospital das Clínicas de Ribeirão Preto

Enrollment

425 participants

Start Date

Feb 28, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 YearsMax Age: 80 Years

Inclusion Criteria5

  • 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 Criteria14

  • 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

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Interventions

DEVICECPAP

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

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NCT07044830


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