Chronic Obstructive Pulmonary DiseaseResWaveNCT06432920
A Wearable In-phase Chest Wall Vibration Device for Relief of Dyspnoea in COPD: a First-in-human Exploratory Study
A study testing ResWave in people with Chronic Obstructive Pulmonary Disease and Dyspnea, run by Elevre Medical Ltd. at 1 site in Ireland.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease, Dyspnea
- What is being tested?
- ResWave
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteIreland
- Study dates
- 6 Jul 2023to 26 Jan 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 20Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Chronic Obstructive Pulmonary Disease, Dyspnea
- Being tested
- ResWave
- Keywords
- dyspnea, COPD, chronic obstructive pulmonary disease, cpet, cardiopulmonary exercise testing, chest wall vibration
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Dyspnea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ResWaveDevice
Prototype wearable in-phase chest wall vibration device
| Study group | Role | What they receive |
|---|---|---|
| ResWave | Experimental | In-phase Chest Wall Vibration worn and active during constant work rate exercise testing. Receives: Device: ResWave |
| Control | Placebo comparator | In-phase Chest Wall Vibration worn and inactive (off) during constant work rate exercise testing. Receives: Device: ResWave |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Events
Adverse Events during or following use of the prototype device and/or exercise testing protocol
Measured: 72 hours
Device Deficiencies
Performance data of the device during use
Measured: During active use in exercise testing
Secondary outcomes (16)
Dyspnea severity
Borg Category-Ratio scale (Borg CR10). Scale from 0 (lowest intensity, better) to 10 (maximal intensity, worse).
Measured: Recorded at 2 minute intervals during exercise testing. Outcome measure at isotime.
Endurance time
Exercise testing endurance time
Measured: Duration of exercise testing
Reason for stopping
Whether participant stopped exercise testing due to dyspnea or other reason
Measured: During exercise testing
Minute Ventilation (VE)
Minute Ventilation in millilitres/minute (mL/min)
Measured: During exercise testing
Heart Rate (HR)
Heart rate in beats per minute (BPM)
Measured: During exercise testing
Oxygen Pulse
Oxygen Pulse (VO2/HR) in millilitres/minute (mL/min)
Measured: During exercise testing
Oxygen Consumption
Oxygen Consumption (VO2) in millilitres/minute (mL/min)
Measured: During exercise testing
Carbon Dioxide Production
Carbon Dioxide Production (VCO2) in millilitres/minute (mL/min)
Measured: During exercise testing
Work
Work (W) in watts
Measured: During exercise testing
Tidal Volume (VT)
Tidal Volume in Litres (L) at body temperature and pressure saturated (BTPS)
Measured: During exercise testing
Respiratory Quotient (RQ)
Respiratory Quotient (CO2 produced / O2 consumed; no unit as it is a ratio value)
Measured: During exercise testing
End-tidal carbon dioxide tension (PETCO2)
End-tidal carbon dioxide tension (PETCO2) in millimetres of mercury (mmHg)
Measured: During exercise testing
End-tidal oxygen tension (PETO2)
End-tidal oxygen tension (PETO2) in millimetres of mercury (mmHg)
Measured: During exercise testing
Oxygen Saturation (SpO2)
Oxygen Saturation (SpO2) (%, percentage)
Measured: During exercise testing
Respiratory Reserve
Respiratory Reserve in Litres
Measured: During exercise testing
Expiration Time
Expiration Time in seconds
Measured: During exercise testing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2024
- Study start6 Jul 2023
- Primary completion26 Jan 2024
- Study completion26 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- 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.
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Elevre Medical Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Beacon Hospital
- Responsible party
- Sponsor
- Investigators
- Professor Seamus Linnane (MB BCh BAO FRCP FRCPI), Principal investigator, Beacon Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06432920
- Sponsor's protocol ID
- RW-CIP 1.2
- Acronym
- ResWave
- Status last verified
- May 2024
- First submitted
- 17 May 2024
- Last updated
- 29 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Wearable In-phase Chest Wall Vibration Device for Relief of Dyspnoea in COPD: a First-in-human Exploratory Study
- ClinicalTrials.gov ID
- NCT06432920
- Acronym / sponsor ID
- ResWave / RW-CIP 1.2
- Conditions
- Chronic Obstructive Pulmonary Disease, Dyspnea
- Keywords
- dyspnea, COPD, chronic obstructive pulmonary disease, cpet, cardiopulmonary exercise testing, chest wall vibration
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Elevre Medical Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Beacon Hospital
- Study start
- 6 Jul 2023 (actual)
- Primary completion
- 26 Jan 2024 (actual)
- Study completion
- 26 Jan 2024 (actual)
- First posted
- 29 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| ResWave | Experimental | Device: ResWaveIn-phase Chest Wall Vibration worn and active during constant work rate exercise testing. |
| Control | Placebo comparator | Device: ResWaveIn-phase Chest Wall Vibration worn and inactive (off) during constant work rate exercise testing. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (20 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ResWavePrototype wearable in-phase chest wall vibration device | Device | Control, ResWave |
Primary outcome
Adverse Events
Time frame: 72 hours
Adverse Events during or following use of the prototype device and/or exercise testing protocol
Device Deficiencies
Time frame: During active use in exercise testing
Performance data of the device during use
16 secondary outcomes
Dyspnea severity
Time frame: Recorded at 2 minute intervals during exercise testing. Outcome measure at isotime.
Endurance time
Time frame: Duration of exercise testing
Reason for stopping
Time frame: During exercise testing
Minute Ventilation (VE)
Time frame: During exercise testing
Heart Rate (HR)
Time frame: During exercise testing
Oxygen Pulse
Time frame: During exercise testing
Oxygen Consumption
Time frame: During exercise testing
Carbon Dioxide Production
Time frame: During exercise testing
Work
Time frame: During exercise testing
Tidal Volume (VT)
Time frame: During exercise testing
Respiratory Quotient (RQ)
Time frame: During exercise testing
End-tidal carbon dioxide tension (PETCO2)
Time frame: During exercise testing
End-tidal oxygen tension (PETO2)
Time frame: During exercise testing
Oxygen Saturation (SpO2)
Time frame: During exercise testing
Respiratory Reserve
Time frame: During exercise testing
Expiration Time
Time frame: During exercise testing
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2024.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Professor Seamus Linnane (MB BCh BAO FRCP FRCPI) principal investigator
Beacon Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ResWave in people with Chronic Obstructive Pulmonary Disease and Dyspnea, run by Elevre Medical Ltd. at 1 site in Ireland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ireland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse Events (time frame: 72 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2024.