Tests a sleep breathing device in people recovering from ischemic stroke
Tests CPAP, a breathing device for sleep apnea, in adults with ischemic stroke.
Key facts
- Who runs it
- Hospital das Clínicas de Ribeirão Preto
- Where
- Ribeirão Preto, BrazilSee the site
- Trial code
- Registry title
- Obstructive Sleep Apnea Treatment From Acute to Chronic Phase of Stroke
- Status
- Recruiting
- People taking part
- 425 people, planned
- Started
- 28 Feb 2024
- Expected to end
- 28 Feb 2031
- Type of study
- Interventional, 5 groupsOne group gets an existing treatment, for comparison.
- Treatments tested
- CPAP
- Record updated
- 1 July 2025
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults aged 18 to 80 who had a new ischemic stroke. It tests early CPAP treatment for sleep apnea to see if it helps recovery.
- Age
- 18 to 80 years
- Sex
- All sexes can join.
- Disease stage
- A new ischemic stroke in the upper brain (supratentorial, not lacunar). Symptoms started or were noticed less than 12 hours before admission. Stroke severity score (NIHSS) of 4 to 20.
- Earlier treatment
- People who already use CPAP, or whose earlier CPAP failed, cannot join.
Main reasons for not taking part
- A previous stroke
- A known sleep apnea diagnosis with current CPAP use or earlier failed CPAP
- Disability before the stroke (mRS above 1)
- Coma, stupor, or a breathing tube in the windpipe
- Pregnant or suspected pregnant women
The registry criteria, word for word
Show all 19 criteriaShow less
Who can take part
- 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
Who cannot take part
- Prior stroke
- Previous diagnosis of OSA with current CPAP use or previously failed CPAP
- Oxygen therapy >2 L/min
- Chronic alcohol or drug use with high risk of withdrawal during hospitalization
- Pre-stroke disability (mRS > 1)
- Clinical instability or severe pre-existing illness (e.g., heart failure, oxygen-dependent COPD, renal or hepatic failure)
- Known severe neurological disease (e.g., dementia, Parkinson's disease, multiple sclerosis, or other neurodegenerative conditions)
- Coma or stupor
- Orotracheal intubation
- Psychomotor agitation
- High likelihood of neurosurgical intervention within the first 48 hours
- Pregnant or suspected pregnant women
- Inability to complete follow-up for any reason
- Any contraindication to CPAP use
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 80 years old?
Where in Brazil
- Hospital das Clínicas, Ribeirão Preto Medical School, University of São PauloRibeirão Preto, BrazilContact: Millene Camilo, MD, PhDTaking people
About the trial
What the trial wants to find out
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.
The 5 groups in the trial
- Severe OSA treatedExisting treatment, for comparison
AHI≥30: treated with CPAP
Treatment: CPAP
- Severe OSA untreatedNo study treatment, for comparison
AHI≥30: without CPAP
- No OSANo study treatment, for comparison
AHI\<5
- Mild OSANo study treatment, for comparison
5≥AHI\<15
- Moderate OSANo study treatment, for comparison
15≤AHI\<30
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Obstructive Sleep Apnea Treatment From Acute to Chronic Phase of Stroke - A Randomized Clinical Trial
- Plain-language title
- Tests a sleep breathing device in people recovering from ischemic strokeGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Fit questions
- Built from NCT07044830, who can take part
- Record updated
- 1 July 2025