Obstructive Sleep Apnea Treatment From Acute to Chronic Phase of Stroke - A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 425
- 试验地点
- 2
- 主要终点
- Functional disability
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Severe OSA untreated
AHI≥30: without CPAP
Severe OSA treated
AHI≥30: treated with CPAP
干预措施: CPAP (Device)
No OSA
AHI<5
Mild OSA
5≥AHI<15
Moderate OSA
15≤AHI<30
结局指标
主要结局
Functional disability
时间窗: 3 months
Measured by the modified Rankin Scale, ranging from 0 (no symptoms) to 6 (death), with higher scores indicating greater disability and dependence on daily activities.
次要结局
- Depressive episode(Day 5/discharge, 3 months, 1 year, and 2 years)
- Depressive episode(Day 5/discharge, 3 months, 1 year, and 2 years)
- Excessive daytime sleepiness(Admission, 3 months, 6 months, 1 year, and 2 years)
- Mortality(2 years)
- Neurological impairment(Admission, 72 hours, day 5/discharge, 3 months, and 6 months)
- Functional independence(Day 5/discharge, 3 months, 6 months, 1 year, and 2 years)
- Cognitive impairment(Day 5/discharge, 3 months, 1 year, and 2 years)
- Subjective quality of life(Day 5/discharge, 3 months, 6 months, 1 year, and 2 years)
研究者
Millene Rodrigues Camilo
Principal Investigator
Hospital das Clínicas de Ribeirão Preto