## Protocol Section
### Identification Module
**NCT ID:** NCT06432920

**Acronym:** ResWave

**Brief Title:** 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

#### Organization Study ID Info
**ID:** RW-CIP 1.2
#### Organization
**Class:** INDUSTRY
**Full Name:** Elevre Medical Ltd.
### Status Module
#### Completion Date
**Date:** 2024-01-26

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-29

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-22

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2024-01-26

**Type:** ACTUAL

#### Start Date
**Date:** 2023-07-06

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-29
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-17
**Study First Submit QC Date:** 2024-05-22
### Sponsor Collaborators Module

#### Collaborators

**Class:** OTHER

**Name:** Beacon Hospital

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** Elevre Medical Ltd.

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**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.

### Conditions Module

**Conditions:**

- Chronic Obstructive Pulmonary Disease

- Dyspnea

**Keywords:**

- dyspnea

- COPD

- chronic obstructive pulmonary disease

- cpet

- cardiopulmonary exercise testing

- chest wall vibration

### Design Module

#### Design Info

**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.

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 20

**Type:** ACTUAL

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** In-phase Chest Wall Vibration worn and active during constant work rate exercise testing.

**Intervention Names:**

- Device: ResWave

**Label:** ResWave

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** In-phase Chest Wall Vibration worn and inactive (off) during constant work rate exercise testing.

**Intervention Names:**

- Device: ResWave

**Label:** Control

**Type:** PLACEBO_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Control

- ResWave

**Description:** Prototype wearable in-phase chest wall vibration device

**Name:** ResWave

**Type:** DEVICE

### Outcomes Module

#### Primary Outcomes

**Description:** Adverse Events during or following use of the prototype device and/or exercise testing protocol

**Measure:** Adverse Events

**Time Frame:** 72 hours

**Description:** Performance data of the device during use

**Measure:** Device Deficiencies

**Time Frame:** During active use in exercise testing

#### Secondary Outcomes

**Description:** Borg Category-Ratio scale (Borg CR10). Scale from 0 (lowest intensity, better) to 10 (maximal intensity, worse).

**Measure:** Dyspnea severity

**Time Frame:** Recorded at 2 minute intervals during exercise testing. Outcome measure at isotime.

**Description:** Exercise testing endurance time

**Measure:** Endurance time

**Time Frame:** Duration of exercise testing

**Description:** Whether participant stopped exercise testing due to dyspnea or other reason

**Measure:** Reason for stopping

**Time Frame:** During exercise testing

**Description:** Minute Ventilation in millilitres/minute (mL/min)

**Measure:** Minute Ventilation (VE)

**Time Frame:** During exercise testing

**Description:** Heart rate in beats per minute (BPM)

**Measure:** Heart Rate (HR)

**Time Frame:** During exercise testing

**Description:** Oxygen Pulse (VO2/HR) in millilitres/minute (mL/min)

**Measure:** Oxygen Pulse

**Time Frame:** During exercise testing

**Description:** Oxygen Consumption (VO2) in millilitres/minute (mL/min)

**Measure:** Oxygen Consumption

**Time Frame:** During exercise testing

**Description:** Carbon Dioxide Production (VCO2) in millilitres/minute (mL/min)

**Measure:** Carbon Dioxide Production

**Time Frame:** During exercise testing

**Description:** Work (W) in watts

**Measure:** Work

**Time Frame:** During exercise testing

**Description:** Tidal Volume in Litres (L) at body temperature and pressure saturated (BTPS)

**Measure:** Tidal Volume (VT)

**Time Frame:** During exercise testing

**Description:** Respiratory Quotient (CO2 produced / O2 consumed; no unit as it is a ratio value)

**Measure:** Respiratory Quotient (RQ)

**Time Frame:** During exercise testing

**Description:** End-tidal carbon dioxide tension (PETCO2) in millimetres of mercury (mmHg)

**Measure:** End-tidal carbon dioxide tension (PETCO2)

**Time Frame:** During exercise testing

**Description:** End-tidal oxygen tension (PETO2) in millimetres of mercury (mmHg)

**Measure:** End-tidal oxygen tension (PETO2)

**Time Frame:** During exercise testing

**Description:** Oxygen Saturation (SpO2) (%, percentage)

**Measure:** Oxygen Saturation (SpO2)

**Time Frame:** During exercise testing

**Description:** Respiratory Reserve in Litres

**Measure:** Respiratory Reserve

**Time Frame:** During exercise testing

**Description:** Expiration Time in seconds

**Measure:** Expiration Time

**Time Frame:** During exercise testing

### Eligibility Module

**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

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Sandyford

**Country:** Ireland

**Facility:** Beacon Hospital

**State:** Dublin 18

**Zip:** D18 AK68

#### Overall Officials

**Official 1:**

**Affiliation:** Beacon Hospital

**Name:** Professor Seamus Linnane (MB BCh BAO FRCP FRCPI)

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**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.

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000012140

- Term: Respiratory Tract Diseases

- ID: D000002908

- Term: Chronic Disease

- ID: D000020969

- Term: Disease Attributes

- ID: D000010335

- Term: Pathologic Processes

- ID: D000012120

- Term: Respiration Disorders

- ID: D000012818

- Term: Signs and Symptoms, Respiratory

### Condition Browse Module - Browse Branches

- Abbrev: BC08

- Name: Respiratory Tract (Lung and Bronchial) Diseases

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M7591

- Name: Dyspnea

- Relevance: HIGH

- As Found: Dyspnea

- ID: M11168

- Name: Lung Diseases

- Relevance: HIGH

- As Found: Pulmonary Disease

- ID: M11170

- Name: Lung Diseases, Obstructive

- Relevance: HIGH

- As Found: Obstructive Pulmonary Disease

- ID: M23449

- Name: Pulmonary Disease, Chronic Obstructive

- Relevance: HIGH

- As Found: Chronic Obstructive Pulmonary Disease

- ID: M14977

- Name: Respiratory Tract Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M6147

- Name: Chronic Disease

- Relevance: LOW

- As Found: Unknown

- ID: M22700

- Name: Disease Attributes

- Relevance: LOW

- As Found: Unknown

- ID: M14957

- Name: Respiration Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M15623

- Name: Signs and Symptoms, Respiratory

- Relevance: LOW

- As Found: Unknown

- ID: T1303

- Name: Chronic Graft Versus Host Disease

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000008171

- Term: Lung Diseases

- ID: D000008173

- Term: Lung Diseases, Obstructive

- ID: D000029424

- Term: Pulmonary Disease, Chronic Obstructive

- ID: D000004417

- Term: Dyspnea

### Misc Info Module

- Version Holder: 2024-05-31
