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

NCT ID: NCT06432920

Last Updated: 2024-05-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-07-06
• Study Completion Date: 2024-01-26

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

Chronic Obstructive Pulmonary Disease; Dyspnea

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

ResWave

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

Group Type: EXPERIMENTAL

ResWave

Intervention Type: DEVICE

Prototype wearable in-phase chest wall vibration device

Control

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

Group Type: PLACEBO_COMPARATOR

ResWave

Intervention Type: DEVICE

Prototype wearable in-phase chest wall vibration device

Interventions

ResWave

Prototype wearable in-phase chest wall vibration device

Intervention Type: DEVICE

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 Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Beacon Hospital

OTHER

Sponsor Role: collaborator

Elevre Medical Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Professor Seamus Linnane (MB BCh BAO FRCP FRCPI)

Role: PRINCIPAL_INVESTIGATOR

Beacon Hospital

Locations

Beacon Hospital

Sandyford, Dublin 18, Ireland

Countries

Ireland

Other Identifiers

RW-CIP 1.2

Identifier Type: -

Identifier Source: org_study_id