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

NCT06432920 | Completed

• 1 other identifier: RW-CIP 1.2
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Obstructive Pulmonary Disease; Dyspnea

Keywords

dyspnea; COPD; chronic obstructive pulmonary disease; cpet; cardiopulmonary exercise testing; chest wall vibration

Outcome Measures

Primary Outcomes (2)

• Adverse Events

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

  72 hours

• Device Deficiencies

  Performance data of the device during use

  During active use in exercise testing

Secondary Outcomes (16)

• Dyspnea severity

  Recorded at 2 minute intervals during exercise testing. Outcome measure at isotime.

• Endurance time

  Duration of exercise testing

• Reason for stopping

  During exercise testing

• Minute Ventilation (VE)

  During exercise testing

• Heart Rate (HR)

  During exercise testing

Study Arms (2)

ResWave

EXPERIMENTAL

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

Device: ResWave

Control

PLACEBO COMPARATOR

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

Device: ResWave

Interventions

ResWave DEVICE

Prototype wearable in-phase chest wall vibration device

Control; ResWave

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Elevre Medical Ltd.: lead
• Beacon Hospital: collaborator

Study Sites (1)

Beacon Hospital

Sandyford, Dublin 18, D18 AK68, Ireland

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Dyspnea

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Respiration Disorders; Signs and Symptoms, Respiratory; Signs and Symptoms

Study Officials

• Professor Seamus Linnane (MB BCh BAO FRCP FRCPI)

  Beacon Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: May 17, 2024
• First Posted: May 29, 2024
• Study Start: July 6, 2023
• Primary Completion: January 26, 2024
• Study Completion: January 26, 2024
• Last Updated: May 29, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

IE (1)