Validation of the DreamKit Plethysmography-derived Respiratory Effort Signal Against Esophageal Pressure
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 11
- 试验地点
- 2
- 主要终点
- Breath Amplitude Correlation
研究概览
简要总结
This study has been developed in order to demonstrate the validity of the DreamKit respiratory effort signal.
详细描述
The rationale for undertaking this study is to demonstrate the agreement between the respiratory effort signal amplitude derived from DreamKit vs. the gold-standard esophageal manometry. Data collection will be completed within a single visit, in which participants will undergo simultaneous measurement using the DreamKit device and esophageal manometry. Data collection will be completed during wakefulness, while participants undergo a series of breathing maneuvers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 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
- 是
入选标准
- •Aged ≥18 years;
- •Fluent in English;
- •Able to provide informed consent.
排除标准
- •Contraindication to esophageal pressure monitoring, including a sensitive gag reflex (determined by a positive response to the screening question "do you sometimes or often gag while brushing your teeth?"), dysphagia, nasal obstruction, and/or esophageal disorder likely to impact placement of the balloon;
- •Pregnancy or planned pregnancy during the study (self-reported);
- •History of allergic reactions to medical adhesives;
- •Known allergy to lidocaine;
- •Known seizure disorder;
- •Severe medical condition (controlled or uncontrolled) impacting breathing including neuromuscular disease, chronic obstructive pulmonary disease, respiratory failure or insufficiency, or requirement for oxygen therapy;
- •Chronic cardiopulmonary or renal disease, including a history of irregular heart rhythms or dyspnea;
- •At risk for excessive bleeding including use of anticoagulants;
- •An employee, or spouse of an employee, of a company that designs, sells, or manufactures sleep related products (including Philips);
- •An employee, or spouse of an employee, of Pulmonary & Critical Care Associates of Baltimore.
结局指标
主要结局
Breath Amplitude Correlation
时间窗: Baseline
The primary endpoint is the intraclass correlation coefficient (ICC) of the peak-to-peak breath amplitude sequences extracted from the DreamKit and esophageal manometry respiratory effort signals during periods of occluded inspiration, end-expiratory breath holds, increased inspiratory resistance, increased expiratory resistance, and unresisted shallow breathing. The DreamKit Home Sleep Test device's effort signal is an uncalibrated signal. The amplitudes derived from the DreamKit Home Sleep Test device's effort signal were scaled for each subject to have the same variance across all tested breathing maneuvers. The lower-bound of the CI was compared against a target of 0.5.
次要结局
未报告次要终点