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

NCT06432920 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2024-05-29

No results posted yet for this study

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

Interventions

DEVICE

ResWave

Prototype wearable in-phase chest wall vibration device

Sponsors & Collaborators

  • Beacon Hospital

    collaborator OTHER

  • Elevre Medical Ltd.

    lead INDUSTRY

Principal Investigators

  • Professor Seamus Linnane (MB BCh BAO FRCP FRCPI) · Beacon Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-07-06
Primary Completion
2024-01-26
Completion
2024-01-26

Countries

  • Ireland

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06432920 on ClinicalTrials.gov