Obstructive Sleep Apnea Treatment From Acute to Chronic Phase of Stroke
NCT ID: NCT07044830
Last Updated: 2025-07-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
425 participants
INTERVENTIONAL
2024-02-28
2031-02-28
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Severe OSA treated
AHI≥30: treated with CPAP
CPAP
Automatically-adjusting continuous positive airway pressure (CPAP)
Severe OSA untreated
AHI≥30: without CPAP
No interventions assigned to this group
No OSA
AHI\<5
No interventions assigned to this group
Mild OSA
5≥AHI\<15
No interventions assigned to this group
Moderate OSA
15≤AHI\<30
No interventions assigned to this group
Interventions
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CPAP
Automatically-adjusting continuous positive airway pressure (CPAP)
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
80 Years
ALL
No
Sponsors
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Fundação de Amparo à Pesquisa do Estado de São Paulo
OTHER_GOV
ResMed Foundation
OTHER
Hospital das Clínicas de Ribeirão Preto
OTHER
Responsible Party
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Millene Rodrigues Camilo
Principal Investigator
Locations
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Hospital das Clínicas, Ribeirão Preto Medical School, University of São Paulo
Ribeirão Preto, São Paulo, Brazil
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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20802619.2.0000.5440
Identifier Type: -
Identifier Source: org_study_id
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