Study of the Effects of Nasal High Flow Therapy as a Treatment Option for Patients With Respiratory Insufficiencies During Sleep.
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 6
- 试验地点
- 4
- 主要终点
- Treatment Efficacy
研究概览
简要总结
Respiratory insufficiencies during sleep can lead to reductions in the level of oxygen in the blood during the night, which has been shown to contribute to a range of morbidities.
The purpose of this study is to assess the possibility that a nasal high flow therapy device may be able to treat respiratory insufficiencies, by stabilizing breathing and preventing reduction in blood oxygen.
Heart failure patients will be screened at a heart failure clinic, and will be asked to undergo an overnight sleep study to determine is they exhibit respiratory insufficiencies during sleep. This sleep study may be completed in the sleep laboratory (attended polysomnography, PSG) or in-home (in-home polygraphy, PG). If they are diagnosed with respiratory insufficiencies, they will be asked to attend further overnight studies to see if treatment with nasal high flow therapy can be used to stabilize breathing.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 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
- •Men and Women aged ≥ 18 years
- •Heart Failure from ischemic or non-ischemic dilated cardiomyopathy for ≥ 6 months
- •Left ventricular systolic dysfunction (LVEF ≤45% by echocardiography performed within 3 months of the screening visit, or if not within 3 months, a justification provided by the cardiologist for why a repeat echocardiography is not required, for example, because the subject's condition has remained stable since their echocardiography). All echocardiography must be within a maximum of 1 year of the screening visit.
- •New York Heart Association Class II or III after optimization of medical therapy
- •Stable Clinical Status on stable optimal medical therapy for ≥ 1 month before entry
排除标准
- •Unstable angina
- •Myocardial infarction within the last 12 months
- •Cardiac surgery within the previous 6 months
- •Pregnancy
- •Unwilling or unable to provide informed consent
- •Uncontrolled arrhythmias
- •Severe valvular heart disease
- •Current/prior use of mechanical ventilation (including CPAP). At the investigator's discretion.
结局指标
主要结局
Treatment Efficacy
时间窗: During 1 night of Sleep on PSG
The primary endpoint of the trial is to the efficacy of using nasal high flow therapy to stabilize breathing, as measured by the breath flow signal from PSG.
次要结局
未报告次要终点