NCT06432920Completed
A Wearable In-phase Chest Wall Vibration Device for Relief of Dyspnoea in COPD: a First-in-human Exploratory Study
Source: ClinicalTrials.gov · Last updated 29 May 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 20 (actual)
- First submitted
- 17 May 2024
- Start date
- 6 Jul 2023
- Primary completion date
- 26 Jan 2024
- Lead sponsor
- Elevre Medical Ltd.
- Diseases
- COPD
- NCT number
- NCT06432920
What you commit to
- Study type: Interventional
- Participants enrolled: 20
- From 6 Jul 2023 to the primary completion date, 26 Jan 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study design.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Receiving domiciliary oxygen therapy
- Diagnosis of COVID-19 within the last 12 weeks or persistent symptoms directly attributable to previous COVID-19 infection
- Abdominal or Thoracic surgery in last 3 months
- Women of child-bearing age (premenopausal, under age 50, or without previous sterilisation surgery)
- 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
Other illness
- Active pulmonary infection or exacerbation within last 6 weeks
- Unstable cardiac disease - cardiac intervention, change in symptoms or medication within last 6 weeks
- Presence of comorbid condition that is deemed to be a significant contributor to dyspnoea: Heart Failure, Chronic Thromboembolic Disease, Neuromuscular Disease, Primary Pulmonary Hypertension
- Active malignancy
- Active chest wall pain, active skin condition or open wound on thorax
- On anticoagulants or with known history of coagulopathy
- 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
Other
- BMI \> 35
- Pulmonary Embolism in last 3 months
- Pneumothorax in last 6 months
- Pregnant or breastfeeding
- Any implantable electronic device
- Any absolute or relative contraindication to CPET testing
- Currently enrolled in any other clinical trial or research study
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Beacon Hospital Coordinator of this site? Confirm its status | Sandyford | Ireland | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.