A Wearable In-phase Chest Wall Vibration Device for Relief of Dyspnoea in COPD: a First-in-human Exploratory Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Adverse Events
研究概览
简要总结
The goal of this exploratory clinical trial is to evaluate the initial clinical safety and performance of a prototype wearable chest wall vibration (CWV) device intended to relieve exertional dyspnea in adults with Chronic Obstructive Pulmonary Disease. The main questions it aims to answer are:
- Can CWV be delivered safely to participants via a wearable device?
- Is there evidence of an effect on participant-reported dyspnea, endurance time and other measures of cardiorespiratory function?
Participants will undergo two cycle-ergometer exercise testing sessions while wearing the prototype wearable device. The device will be active in one session (intervention) and inactive in the other (control). The order in which intervention or control occurs will be randomised. Researchers gather data relating to adverse events, device deficiencies, participant-reported symptom severity, endurance time and measures of cardiorespiratory function recorded via standard CPET apparatus.
详细描述
The purpose of this Clinical Investigation is to evaluate the device design in a small number of human subjects with respect to initial clinical safety, and to gather preliminary data regarding the effect of the device on patient reported dyspnoea and physiological measures of cardiorespiratory function. This will facilitate planning of further steps of device development and validation, guide design modifications and define parameters for a future pivotal clinical investigation.
The investigational device is at Pilot stage of Clinical Development, and the proposed Clinical investigation is a first-in-human exploratory study. It is not a superiority, non-inferiority, or equivalence study.
The primary objective of this Clinical Investigation is to evaluate the investigational device with respect to initial clinical safety when used by subjects with Chronic Obstructive Pulmonary Disease during physical exertion in the form of cycle ergometer-based Cardiopulmonary Exercise Testing.
The secondary objective of this Clinical Investigation is to gather preliminary data regarding the effect of the device on patient-reported dyspnoea and physiological measures of cardiorespiratory function.
Each subject will attend the investigation site for a Pre-Study visit during which formal written consent will be obtained, clinical history and medications will be reviewed as part of standard CPET pre-assessment, and enrolment in the Clinical Investigation will be complete.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 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
- •Diagnosis of Chronic Obstructive Pulmonary Disease (COPD) with FEV1 / FVC ratio of < 75% and deemed clinically stable
- •Moderate to severe airflow limitation on Spirometry (FEV1: 30 to 75% predicted)
- •Pulmonary Function Testing completed in the last 6 months
排除标准
- •Active pulmonary infection or exacerbation within last 6 weeks
- •Unstable cardiac disease - cardiac intervention, change in symptoms or medication within last 6 weeks
- •BMI > 35
- •Receiving domiciliary oxygen therapy
- •Diagnosis of COVID-19 within the last 12 weeks or persistent symptoms directly attributable to previous COVID-19 infection
- •Presence of comorbid condition that is deemed to be a significant contributor to dyspnoea: Heart Failure, Chronic Thromboembolic Disease, Neuromuscular Disease, Primary Pulmonary Hypertension
- •Pulmonary Embolism in last 3 months
- •Abdominal or Thoracic surgery in last 3 months
- •Pneumothorax in last 6 months
- •Active malignancy
- •Active chest wall pain, active skin condition or open wound on thorax
- •Pregnant or breastfeeding
- •Women of child-bearing age (premenopausal, under age 50, or without previous sterilisation surgery)
- •Any implantable electronic device
- •On anticoagulants or with known history of coagulopathy
- •Any absolute or relative contraindication to CPET testing
- •Disability or comorbid condition that prevents exercise training and/or use of CPET apparatus and/or wearing the investigational device
- •Previous experience of Chest Wall Vibration therapies for relief of breathlessness
- •Currently enrolled in any other clinical trial or research study
- •People deemed to be incapable of giving consent, or with reduced capacity to consent or diminished autonomy as a result of mental or cognitive impairment, or deemed otherwise vulnerable on clinical grounds
结局指标
主要结局
Adverse Events
时间窗: 72 hours
Adverse Events during or following use of the prototype device and/or exercise testing protocol
Device Deficiencies
时间窗: During active use in exercise testing
Performance data of the device during use
次要结局
- Dyspnea severity(Recorded at 2 minute intervals during exercise testing. Outcome measure at isotime.)
- Endurance time(Duration of exercise testing)
- Reason for stopping(During exercise testing)
- Minute Ventilation (VE)(During exercise testing)
- Oxygen Pulse(During exercise testing)
- Heart Rate (HR)(During exercise testing)
- Oxygen Consumption(During exercise testing)
- Carbon Dioxide Production(During exercise testing)
- Respiratory Quotient (RQ)(During exercise testing)
- Work(During exercise testing)
- Tidal Volume (VT)(During exercise testing)
- Oxygen Saturation (SpO2)(During exercise testing)
- End-tidal carbon dioxide tension (PETCO2)(During exercise testing)
- End-tidal oxygen tension (PETO2)(During exercise testing)
- Respiratory Reserve(During exercise testing)
- Expiration Time(During exercise testing)