Clinical trial NCT06432920: A Wearable In-phase Chest Wall Vibration Device for Relief of Dyspnoea in COPD: a First-in-human Exploratory Study
Official title: A Wearable In-phase Chest Wall Vibration Device for Relief of Dyspnoea in COPD: a First-in-human Exploratory Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Obstructive Pulmonary Disease
Dyspnea
Keywords: dyspnea
COPD
chronic obstructive pulmonary disease
cpet
cardiopulmonary exercise testing
chest wall vibration
Lead sponsor: Elevre Medical Ltd.
Sponsor class: INDUSTRY
Collaborators: name: Beacon Hospital
First posted: 2024-05-29
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Participants undergo constant-work rate cardiopulmonary exercise testing 2 times: once while wearing the active prototype device (intervention) and once wearing the inactive prototype device (control). Order of intervention/control is randomised.
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

An initial Incremental Cardiopulmonary Exercise Testing (CPET) session will then be conducted to determine baseline Peak Work Rate capacity. This is necessary so that the intensity of CPET that will be required to achieve 75% of each subject's individual Peak Work Rate capacity can be determined. Peak Work Rate capacity will be defined as the highest work rate that the Subject is able to maintain for ≥30 seconds.

Following initial CPET, subjects will return for device testing on a non-consecutive day. Each subject will undergo 2 study arms during this visit: the Intervention (ResWave) and Control arms, in the random order. Both arms will be conducted on the same day, with a recovery period of 60 minutes between each arm. Subjects will undergo sub-maximal exercise testing at a Constant Work Rate (CWR) of 75% of their peak work rate capacity in both arms. Borg CR10 scores will be recorded at 2 minute intervals throughout. Endurance time will be recorded at test completion. Adverse Events will be recorded throughout testing and at 72-hour follow-up via phone call. Device Deficiencies will be recorded throughout testing.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Adverse Events
timeFrame: 72 hours
measure: Device Deficiencies
timeFrame: During active use in exercise testing
Secondary outcomes:
measure: Dyspnea severity
timeFrame: Recorded at 2 minute intervals during exercise testing. Outcome measure at isotime.
measure: Endurance time
timeFrame: Duration of exercise testing
measure: Reason for stopping
timeFrame: During exercise testing
measure: Minute Ventilation (VE)
timeFrame: During exercise testing
measure: Heart Rate (HR)
timeFrame: During exercise testing
measure: Oxygen Pulse
timeFrame: During exercise testing
measure: Oxygen Consumption
timeFrame: During exercise testing
measure: Carbon Dioxide Production
timeFrame: During exercise testing
measure: Work
timeFrame: During exercise testing
measure: Tidal Volume (VT)
timeFrame: During exercise testing
measure: Respiratory Quotient (RQ)
timeFrame: During exercise testing
measure: End-tidal carbon dioxide tension (PETCO2)
timeFrame: During exercise testing
measure: End-tidal oxygen tension (PETO2)
timeFrame: During exercise testing
measure: Oxygen Saturation (SpO2)
timeFrame: During exercise testing
measure: Respiratory Reserve
timeFrame: During exercise testing
measure: Expiration Time
timeFrame: During exercise testing
Other outcomes:
Locations:
city: Sandyford
country: Ireland
facility: Beacon Hospital
state: Dublin 18
Study officials:
affiliation: Beacon Hospital
name: Professor Seamus Linnane (MB BCh BAO FRCP FRCPI)
role: PRINCIPAL_INVESTIGATOR
References: