Treatment of Central Sleep Apnoea and Cheyne Stokes Respiration in Patients With Heart Failure: Nasal High-flow Oxygen Therapy?
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- Reduction of apnea/hypopnea index
研究概览
简要总结
To investigate whether nHFT is an effective treatment for patients with Chronic Heart Failure (CHF) and central sleep apnea (CSA).
This study is a prospective one armed uncontrolled intervention pilot study investigating 4 weeks of nHFT at home in 10 patients with CHF and CSA.
详细描述
Study population: 10 CHF patients with a Left Ventricular Injection Fraction(LVEF)< 45% and CSA/Cheyne Stokes Respiration (CSR) (apnoea/hypopnea index (AHI) > 15/hour); with at least 50% of the total number of events having a central character will be included. Patients with other diseases that will influence the respiratory system negatively during sleep i.e. chronic obstructive pulmonary disease (COPD Global Initiative of Obstructive Lung Diseases (GOLD) class 3 and 4), neuromuscular diseases and thorax cage deformities, as well as patients with CHF and CSA that use another form of treatment for their CSA at the time of inclusion, will be excluded.
Intervention: nHFT will be titrated during a first titration night and used at home during the night for 4 weeks consecutively.
Main study parameters/endpoints:
- To investigate the effect of nHFT with and without oxygen in reducing the apnoea/hypopnoea index during sleep after 4 weeks use nHFT.
- To investigate improvements in oxygen desaturation index, sleep quality and sleepiness, physical condition, left ventricular ejection fraction (LVEF), heart beat variability (HRV), N-terminal natriuretic peptide (NTproBNP) after 4 weeks use nHFT .
- Physiological condition; work of breathing and respiratory drive and measuring mouth-throat pressure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Moderate to severe CSA/CSR (AHI>15), in which CSA is defined when at least 50% of the apnoeas are central apnoeas
- •Heart failure with reduced ejection fraction, defined as a LVEF < 45% of predicted
排除标准
- •Other diseases affecting respiration during sleep (COPD GOLD 3 or 4, neuromuscular disorders, thorax cage deformities)
- •At the moment of the inclusion, the patient does not have a therapy to treat the CSA, such as continuous positive airway pressure (CPAP), oxygen, bilevel intermittent positive airway pressure (BiPAP) or acetazolamide.
研究组 & 干预措施
Nasal high flow oxygen therapy
The patient is hospitalized for one night.
Initially patients will start with a flow rate of 10 L/min and when they are asleep during the night 90-minute periods of the following settings will be performed:
- Moderate flow rate: 20 L/min without additional oxygen (with room air, which means a fractional inspired oxygen (FiO2) of 21%)
- High flow rate: 40-50 L/min without additional oxygen
- Moderate flow rate: 20 L/min with FiO2 of 28% (comparable to the 2 L/min additional oxygen through a nasal cannula)
- High flow rate: 40-50 L/min with FiO2 of 28%
干预措施: Nasal high flow oxygen therapy (Device)
结局指标
主要结局
Reduction of apnea/hypopnea index
时间窗: Baseline, 4 weeks
the change/reduction in AHI after 4 weeks of treatment with nHFT.
次要结局
- Work of breathing(Baseline titration night)
- Sleep latency(Baseline, 4 weeks)
- change in oxygen desaturation index (ODI) during sleep while on nHFT(Baseline, 4 weeks)
- Total rapid-eye movement (REM) stage sleep cycles recorded(Baseline, 4 weeks)
- Drive to breath(Baseline titration night, 4 weeks)
- Sleep efficiency(Baseline, 4 weeks)
- Improvement physical condition(Baseline, 4 weeks)
- N-terminal natriuretic peptide (NTproBNP)(Baseline, 4 weeks)
- Cardiac functioning(Baseline, 4 weeks)
- Heart rate variability(Baseline, 4 weeks)
研究者
Marieke Duiverman
Pneumologist
University Medical Center Groningen