Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:15 AM
Ignite Modification Date:
2025-12-25 @ 4:15 AM
NCT ID:
NCT06432920
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06432920
Study Brief:
Protocol Section:
NCT06432920