A Wearable In-phase Chest Wall Vibration Device for Relief of Dyspnoea in COPD: a First-in-human Exploratory Study

Chronic Obstructive Pulmonary Disease Clinical Trial

— ResWave  

Official title:

A Wearable In-phase Chest Wall Vibration Device for Relief of Dyspnoea in COPD: a First-in-human Exploratory Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06432920
• Other study ID #: RW-CIP 1.2
• Status: Completed
• Phase: N/A
• Start date: July 6, 2023
• Est. completion date: January 26, 2024

Study information

• Verified date: May 2024
• Source: Elevre Medical Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: January 26, 2024
• Est. primary completion date: January 26, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Dyspnea
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Device:
• ResWave
Prototype wearable in-phase chest wall vibration device

Locations

Country	Name	City	State
Ireland	Beacon Hospital	Sandyford	Dublin 18

Sponsors (2)

Lead Sponsor	Collaborator
Elevre Medical Ltd.	Beacon Hospital

Country where clinical trial is conducted

Ireland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adverse Events	Adverse Events during or following use of the prototype device and/or exercise testing protocol	72 hours
Primary	Device Deficiencies	Performance data of the device during use	During active use in exercise testing
Secondary	Dyspnea severity	Borg Category-Ratio scale (Borg CR10). Scale from 0 (lowest intensity, better) to 10 (maximal intensity, worse).	Recorded at 2 minute intervals during exercise testing. Outcome measure at isotime.
Secondary	Endurance time	Exercise testing endurance time	Duration of exercise testing
Secondary	Reason for stopping	Whether participant stopped exercise testing due to dyspnea or other reason	During exercise testing
Secondary	Minute Ventilation (VE)	Minute Ventilation in millilitres/minute (mL/min)	During exercise testing
Secondary	Heart Rate (HR)	Heart rate in beats per minute (BPM)	During exercise testing
Secondary	Oxygen Pulse	Oxygen Pulse (VO2/HR) in millilitres/minute (mL/min)	During exercise testing
Secondary	Oxygen Consumption	Oxygen Consumption (VO2) in millilitres/minute (mL/min)	During exercise testing
Secondary	Carbon Dioxide Production	Carbon Dioxide Production (VCO2) in millilitres/minute (mL/min)	During exercise testing
Secondary	Work	Work (W) in watts	During exercise testing
Secondary	Tidal Volume (VT)	Tidal Volume in Litres (L) at body temperature and pressure saturated (BTPS)	During exercise testing
Secondary	Respiratory Quotient (RQ)	Respiratory Quotient (CO2 produced / O2 consumed; no unit as it is a ratio value)	During exercise testing
Secondary	End-tidal carbon dioxide tension (PETCO2)	End-tidal carbon dioxide tension (PETCO2) in millimetres of mercury (mmHg)	During exercise testing
Secondary	End-tidal oxygen tension (PETO2)	End-tidal oxygen tension (PETO2) in millimetres of mercury (mmHg)	During exercise testing
Secondary	Oxygen Saturation (SpO2)	Oxygen Saturation (SpO2) (%, percentage)	During exercise testing
Secondary	Respiratory Reserve	Respiratory Reserve in Litres	During exercise testing
Secondary	Expiration Time	Expiration Time in seconds	During exercise testing