The Effects of Continuous Positive Airway Pressure Therapy Withdrawal on Cerebral Vascular Reactivity and Brain Oxygenation in Patients With Obstructive Sleep Apnoea: A Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 49
- 试验地点
- 2
- 主要终点
- Cerebrovascular reactivity (CVR)
研究概览
简要总结
Obstructive sleep apnoea (OSA) is a highly prevalent sleep-related breathing disorder associated with adverse cardiovascular outcome. Underlying mechanisms are subject of debate. A causal relationship between OSA and systemic hypertension as well as peripheral endothelial dysfunction was shown, and there is accumulating evidence from physiologic and observational studies that cerebral autoregulation is insufficient to protect the brain from the nocturnal consequences of OSA. However, there are no data from randomised controlled trials proving a causal relationship between OSA and impaired cerebral vascular reactivity (CVR). The aim of this randomised controlled trial is to study the effects of a short-term CPAP withdrawal, and thus returning OSA, on daytime CVR and brain oxygenation to establish whether there is a causal relationship between OSA and cerebral vascular damage.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Objectively confirmed OSA (at the time of original diagnosis) with an oxygen desaturation index (ODI) and apnoea-hypopnoea-index (AHI) of ≥20/h.
- •Currently an oxygen desaturation index (≥4% dips) of ≥15/h during an ambulatory nocturnal pulse oximetry performed on the last night of a four-night period off CPAP.
- •Treated with CPAP for more than 12 months
- •Device usage >4h per night, >80% of the last 365 days, and AHI<10 with treatment (according to CPAP machine download data).
- •Age between 20 and 75 years.
- •Written informed consent as documented by signature.
排除标准
- •Previous ischemic or haemorrhagic stroke; known cerebral aneurysm or arterio-venous malformation.
- •Carotid artery stenosis > 70%
- •Use of alpha- and beta-adrenergic blocking medication, antianginal medications, triptans, selective COX-inhibitors
- •Unstable, untreated coronary or peripheral artery disease, severe arterial hypertension or hypotension (>180/110 or <90/60mmHg)
- •Implanted pacemaker or internal cardiac defibrillator
- •Changes in medication during the trial
- •Previous ventilatory failure (awake SpO2 <93% andPaCO2>6kPa).
- •Obesity hypoventilation syndrome, COPD
- •Previously diagnosed with Cheyne-Stokes breathing.
- •Current professional driver or any previous sleep related driving accidents.
- •Caffeine or nicotine abuse 12 hours before measurements
研究组 & 干预措施
CPAP therapy
Continuous positive airway pressure therapy
干预措施: Continuous positive airway pressure device (Device)
Sham CPAP
Sham- Continuous positive airway pressure
干预措施: Continuous positive airway pressure device (Device)
结局指标
主要结局
Cerebrovascular reactivity (CVR)
时间窗: Change from baseline in CVR after 2 weeks of CPAP withdrawal
CVR measured non-invasively by blood oxygen level-dependent (BOLD) magnetic resonance imaging (MRI) under controlled cardiovascular reactivity stimulation during wakefulness
次要结局
- Apnoea-hypopnoea-index (AHI)(Change from baseline in AHI after 2 weeks of CPAP withdrawal)
- Oxygen Desaturation Index (ODI)(Change from baseline in ODI after 2 weeks of CPAP withdrawal)
- Resting heart rate(Change from baseline in resting heart rate after 2 weeks of CPAP withdrawal)
- Ambulatory morning blood pressure(Change from baseline in ambulatory morning blood pressure after 2 weeks of CPAP withdrawal)