Obstructive Sleep Apnea Treatment From Acute to Chronic Phase of Stroke (ATACS)

Hospital das Clínicas de Ribeirão Preto

Status: Enrolling

Conditions: Ischemic Stroke; Obstructive Sleep Apnea

Treatments: Device: CPAP

Study type: Interventional

Funder types: Other

Identifiers

NCT07044830

20802619.2.0000.5440

Details and patient eligibility

About

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.

Full 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.

Enrollment: 425 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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425 participants in 5 patient groups

Severe OSA treated

Active Comparator group

Description:

AHI≥30: treated with CPAP

Treatment:

Device: CPAP

Severe OSA untreated

No Intervention group

Description:

AHI≥30: without CPAP

No OSA

No Intervention group

Description:

AHI\<5

Mild OSA

No Intervention group

Description:

5≥AHI\<15

Moderate OSA

No Intervention group

Description:

15≤AHI\<30