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Recruiting NCT07044830

Obstructive Sleep Apnea Treatment From Acute to Chronic Phase of Stroke

No phase Interventional Ischemic Stroke Obstructive Sleep Apnea

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: CPAP.
Who it may be relevant to
Registry conditions: Ischemic Stroke, Obstructive Sleep Apnea. Basic parameters: 18 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Brazil
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Detailed description

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.

Interventions

  • Device CPAP
    Automatically-adjusting continuous positive airway pressure (CPAP)

Primary outcome measures

  • Functional disability [Time frame: 3 months]
Secondary outcome measures (7)
  • Neurological impairment [Time frame: Admission, 72 hours, day 5/discharge, 3 months, and 6 months]
  • Functional independence [Time frame: Day 5/discharge, 3 months, 6 months, 1 year, and 2 years]
  • Cognitive impairment [Time frame: Day 5/discharge, 3 months, 1 year, and 2 years]
  • Subjective quality of life [Time frame: Day 5/discharge, 3 months, 6 months, 1 year, and 2 years]
  • Depressive episode [Time frame: Day 5/discharge, 3 months, 1 year, and 2 years]
  • Excessive daytime sleepiness [Time frame: Admission, 3 months, 6 months, 1 year, and 2 years]
  • Mortality [Time frame: 2 years]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Brazil · 1 center
  • Hospital das Clínicas, Ribeirão Preto Medical School, University of São Paulo — Ribeirão Preto

Identifiers

NCT: NCT07044830 · 20802619.2.0000.5440

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗