A Feasibility Study of a Non-Invasive Wearable Device in Assessing Airway Responsiveness Related Parameters During Methacholine Challenge Test (MCT)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 37
- 试验地点
- 1
- 主要终点
- Respiratory parameters (Inhalation and Exhalation time and ratio) measured by SG during MCT can indicate for changes in airway obstruction occurred in positive MCT
研究概览
简要总结
SenseGuard (SG) is an innovative device for respiratory monitoring. At this study SG measurement will be integrated in a Methacholine Challenge Test (MCT) for monitoring changes in airway obstruction occurred during MCT in parallel to spirometry.
详细描述
SenseGuard (SG) is a wireless wearable medical device intended for monitoring of patient's breathing. It allows to seamlessly monitor patient's tidal breathing, at rest or during daily activities, and to extract critical respiratory parameters, such as respiration rate (RR) and durations, ratios and variability of phases within the breath-cycle, including: inspired breath (Ti) and expired breath (Te).
The study goal is to evaluate the capability of SG to measure clinical changes in respiratory parameters.
During Methacholine Challenge Test (MCT), asthma patients demonstrate airway responsiveness due to airway obstruction. SG will be used to measure respiratory parameters during MCT in parallel to spirometry and the correlation between measurable respiratory parameters will be assessed.
Successful study results will demonstrate the capability of SG to measure changes in airway obstruction leading to future implementation of SG for monitoring of patients with respiratory diseases and improvement of their clinical outcome.
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
- 否
入选标准
- •Male or female, aged ≥
- •Eligible for MCT procedure. The contradictions to MCT are listed as
排除标准
- •Provision of a signed and dated informed consent form.
- •Subject who receives one of the following medications, that decrease bronchial hyperresponsiveness, is required for a washout period, before conducting the MCT: inhaled bronchodilators, oral albuterol , inhaled and oral glucocorticoids, leukotriene modifying agents, theophylline, cromolyn, and anti-histamines due to their anticholinergic effect.
- •Exclusion Criteria:
- •Subjects who have known contradictions to MCT, including:
- •Tolerate inhalation of the challenge agents
- •Low baseline FEV1: Airflow limitations in FEV1 less than 60% predicted or 1.5L (baseline FEV1 of < 1.5 L or < 60% predicted).
- •Spirometry quality: inability to consistently reproduce quality spirometry
- •Cardiovascular problems: recent myocardial infarction within past three months, uncontrolled hypertension, known aortic aneurysm
- •Recent ophthalmologic surgery or patients at risk for intracranial pressure elevation.
- •Pregnancy and nursing mothers: Methacholine is a pregnancy category C drug and it is not known whether it is excreted in breast milk or is associated with fetal abnormalities. Women subjects will be asked to sign a statement, as part of the Informe Consent Form, that they are not pregnant or nursing mothers).
- •Inability to provide informed consent.
- •Known allergic reactions to materials used in the components of the SG, i.e., polyethylene or silicon, or gold, nickel, copper or alloys containing any of the above.
研究组 & 干预措施
Investigational SenseGuard Device
Subjects with suspected diagnosis of Asthma and eligible for MCT will be recruited to the study.
The MCT procedure will be performed as usual, with the addition of SG measurements after each spirometry for each Methacholine dose.
干预措施: SenseGuard monitoring (Device)
结局指标
主要结局
Respiratory parameters (Inhalation and Exhalation time and ratio) measured by SG during MCT can indicate for changes in airway obstruction occurred in positive MCT
时间窗: 6 months
SG respiratory parameters(Inhalation and Exhalation (I/E) time and ratio), can measure successfully changes in respiratory parameters during MCT procedure, in at least of 70% of the subjects with MCT positive result (FEV1 \< 20% of predicted FEV1).
次要结局
- SG respiratory parameters (Inhalation and Exhalation time and ratio) are in correlation with Spirometry values (FEV1) obtained during MCT(6 months)