Early CPAP treatment for sleep apnea after ischemic stroke
Obstructive Sleep Apnea Treatment From Acute to Chronic Phase of Stroke - A Randomized Clinical Trial
This project tests whether starting CPAP within 48–72 hours after an ischemic stroke helps people with severe obstructive sleep apnea recover better.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 425 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Hospital das Clínicas de Ribeirão Preto Academic / other |
| Locations | 1 site (Ribeirão Preto, São Paulo) |
| Trial ID | NCT07044830 on ClinicalTrials.gov |
What this trial studies
This is a prospective, multicenter, randomized study enrolling adults with acute supratentorial non‑lacunar ischemic stroke. All eligible participants undergo respiratory polygraphy and those found to have severe obstructive sleep apnea are randomized to early CPAP therapy or conservative management. CPAP is started within 48–72 hours of hospital admission and use is continued with follow‑up out to two years. Clinical outcomes and functional recovery are compared between the CPAP and control groups.
Who should consider this trial
Good fit: Adults 18–80 with a recent supratentorial non‑lacunar ischemic stroke admitted within 12 hours, NIHSS 4–20, and severe OSA on respiratory polygraphy are the ideal candidates.
Not a fit: Patients with prior stroke, pre‑stroke disability, current CPAP use or prior CPAP failure, severe comorbid illness, need for high oxygen support, or who have mild/no OSA are unlikely to receive benefit from this protocol.
Why it matters
Potential benefit: If successful, early CPAP could improve functional recovery and reduce long‑term disability after stroke.
How similar studies have performed: CPAP is an established treatment for OSA and smaller post‑stroke studies have suggested potential benefits, but large randomized long‑term trials in the acute stroke setting are limited.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Ribeirão Preto, São Paulo
- Hospital das Clínicas, Ribeirão Preto Medical School, University of São Paulo — Ribeirão Preto, São Paulo, Brazil (Recruiting)
Study contacts
- Study coordinator: Millene Camilo, MD, PhD
- Email: millene.camilo@fmrp.usp.br
- Phone: +55-16-36059075
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.