Exhaled Breath Analysis by Mass Spectrometry in Patients With Obstructive Sleep Apnoea - a Randomised Placebo-controlled Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Exhaled breath pattern.
研究概览
简要总结
Clinical trial in patients with obstructive sleep apnoea that are randomised to either continue or withdraw continuous positive airway pressure therapy to identify a disease-specific exhaled breath pattern by mass spectrometry.
详细描述
Randomised placebo-controlled trial (therapeutic vs. subtherapeutic continuous positive airway pressure [CPAP]) including 30 OSA patients to define the effects of CPAP withdrawal (subtherapeutic CPAP) on the composition of exhaled breath analysed by mass spectrometry for identification of OSA specific markers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Triple (Participant, Care Provider, 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
- •Confirmed OSA (at the time of original diagnosis) with an oxygen desaturation index (ODI) of >20/h.
- •Currently >20/h oxygen desaturations (≥4% dips) during an ambulatory nocturnal pulse oximetry performed on the last night of a 4-night period without CPAP.
- •Treated with CPAP for more than 12 months, minimum compliance 4h/night, apnoea-hypopnoea index (AHI) <10 with treatment (according to CPAP- download) and current ESS <
- •Age between 20 and 75 years at trial entry.
排除标准
- •Previous ventilatory failure (awake SpO2 <93% and PaCO2>6kPa).
- •Unstable, untreated coronary or peripheral artery disease, severe arterial hypertension or hypotension (>180/110 or <90/60mmHg)
- •Previously diagnosed with Cheyne-Stokes breathing.
- •Current professional driver; any previous sleep related accident.
- •Acute inflammatory disease.
- •Acute or chronic hepatic disease.
- •Renal failure or renal replacement therapy.
- •Use of inhaled drugs.
研究组 & 干预措施
Therapeutic CPAP
Patients continue therapeutic continuous positive airway pressure (CPAP).
干预措施: CPAP (Device)
Subtherapeutic CPAP
Placebo-CPAP device delivering subtherapeutic pressure for two weeks.
干预措施: Placebo-CPAP device (Device)
结局指标
主要结局
Exhaled breath pattern.
时间窗: at baseline and at follow-up (2 weeks)
OSA-specific mass spectrometric exhaled breath pattern.
次要结局
- apnoea-hypopnoea index (AHI)(at baseline and at follow-up (2 weeks))
- oxygen desaturation index (ODI), 4% dips(at baseline and at follow-up (2 weeks))
研究者
Malcolm Kohler
Prof. Dr. med.
University of Zurich