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

May 22, 2024 updated by: Elevre Medical Ltd.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Ireland
    • Dublin 18
      • Sandyford, Dublin 18, Ireland, D18 AK68
        • Beacon Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ResWave
In-phase Chest Wall Vibration worn and active during constant work rate exercise testing.
Device: ResWave
Prototype wearable in-phase chest wall vibration device
Placebo Comparator: Control
In-phase Chest Wall Vibration worn and inactive (off) during constant work rate exercise testing.
Device: ResWave
Prototype wearable in-phase chest wall vibration device

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse Events
Time Frame: 72 hours
Adverse Events during or following use of the prototype device and/or exercise testing protocol
72 hours
Device Deficiencies
Time Frame: During active use in exercise testing
Performance data of the device during use
During active use in exercise testing

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Dyspnea severity
Time Frame: Recorded at 2 minute intervals during exercise testing. Outcome measure at isotime.
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.
Endurance time
Time Frame: Duration of exercise testing
Exercise testing endurance time
Duration of exercise testing
Reason for stopping
Time Frame: During exercise testing
Whether participant stopped exercise testing due to dyspnea or other reason
During exercise testing
Minute Ventilation (VE)
Time Frame: During exercise testing
Minute Ventilation in millilitres/minute (mL/min)
During exercise testing
Heart Rate (HR)
Time Frame: During exercise testing
Heart rate in beats per minute (BPM)
During exercise testing
Oxygen Pulse
Time Frame: During exercise testing
Oxygen Pulse (VO2/HR) in millilitres/minute (mL/min)
During exercise testing
Oxygen Consumption
Time Frame: During exercise testing
Oxygen Consumption (VO2) in millilitres/minute (mL/min)
During exercise testing
Carbon Dioxide Production
Time Frame: During exercise testing
Carbon Dioxide Production (VCO2) in millilitres/minute (mL/min)
During exercise testing
Work
Time Frame: During exercise testing
Work (W) in watts
During exercise testing
Tidal Volume (VT)
Time Frame: During exercise testing
Tidal Volume in Litres (L) at body temperature and pressure saturated (BTPS)
During exercise testing
Respiratory Quotient (RQ)
Time Frame: During exercise testing
Respiratory Quotient (CO2 produced / O2 consumed; no unit as it is a ratio value)
During exercise testing
End-tidal carbon dioxide tension (PETCO2)
Time Frame: During exercise testing
End-tidal carbon dioxide tension (PETCO2) in millimetres of mercury (mmHg)
During exercise testing
End-tidal oxygen tension (PETO2)
Time Frame: During exercise testing
End-tidal oxygen tension (PETO2) in millimetres of mercury (mmHg)
During exercise testing
Oxygen Saturation (SpO2)
Time Frame: During exercise testing
Oxygen Saturation (SpO2) (%, percentage)
During exercise testing
Respiratory Reserve
Time Frame: During exercise testing
Respiratory Reserve in Litres
During exercise testing
Expiration Time
Time Frame: During exercise testing
Expiration Time in seconds
During exercise testing

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Elevre Medical Ltd.

Collaborators

Beacon Hospital

Investigators

  • Principal Investigator: Professor Seamus Linnane (MB BCh BAO FRCP FRCPI), Beacon Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 6, 2023

Primary Completion (Actual)

January 26, 2024

Study Completion (Actual)

January 26, 2024

Study Registration Dates

First Submitted

May 17, 2024

First Submitted That Met QC Criteria

May 22, 2024

First Posted (Actual)

May 29, 2024

Study Record Updates

Last Update Posted (Actual)

May 29, 2024

Last Update Submitted That Met QC Criteria

May 22, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RW-CIP 1.2

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

At present there is no plan to share individual participant data (IPD). As this is a novel medical device prototype currently undergoing development, IPD sharing could undermine future research and development activities relating proprietary aspects of the technology.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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