Using portable CPAP to help patients with airway collapse
Portable Continuous Positive Airways Pressure (CPAP) in Excessive Central Airway Collapse (ECAC) Study
This study is testing whether a portable CPAP device can help people with airway collapse breathe better and exercise more easily in their daily lives.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Papworth Hospital NHS Foundation Trust Government |
| Locations | 1 site (Cambridge, Cambridgeshire) |
| Trial ID | NCT06072872 on ClinicalTrials.gov |
What this trial studies
This study investigates the effectiveness of a portable Continuous Positive Airway Pressure (pCPAP) device for managing patients with Excessive Central Airway Collapse (ECAC), a condition that causes significant breathlessness and limits exercise capacity. The research aims to assess how well the pCPAP device improves exercise capacity and alleviates symptoms, as well as to evaluate its feasibility for use during daily activities. Participants will be monitored to determine the impact of the device on their quality of life and physical performance.
Who should consider this trial
Good fit: Ideal candidates include adults over 18 diagnosed with ECAC who experience significant breathlessness primarily due to this condition.
Not a fit: Patients with dynamic collapse of only segmental airways or those with significant comorbidities affecting exercise tolerance may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve the exercise capacity and overall quality of life for patients suffering from ECAC.
How similar studies have performed: While the use of CPAP devices is established for other conditions, this specific application for ECAC is novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Diagnosis of ECAC based on \>50% reduction of the antero-posterior diameter of large airways demonstrated on dynamic CT thorax or bronchoscopy. Only patients with tracheal and/or bilateral large bronchi (main to lobar) involvement will be included. 2. Symptoms of dyspnoea felt to be predominantly caused by ECAC (where ECAC is the only respiratory pathology or dyspnoea is clearly out of proportion to a co-morbid respiratory condition) 3. Medical Research Council (MRC) breathlessness scale of 3 (I stop for breath after walking about 100 yards or after a few minutes on level ground) or more. 4. Age over 18 years 5. Able to give informed consent - Exclusion Criteria: * Patients with dynamic collapse of only segmental airways * Comorbidity which is likely to be an additional limiting factor in exercise tolerance * Contraindication to CPAP * Contraindication to incremental shuttle walk testing (ISWT), including; myocardial infarction within the last 3-5 days, unstable angina, uncontrolled arrhythmia, severe symptomatic cardiac or valvular disease, acute pulmonary embolus, uncontrolled asthma, syncope, mental impairment resulting in inability to perform test. * Resting oxygen saturations \<90% on air or need for ambulatory oxygen therapy * Immobility that would make ISWT unfeasible * Severe emphysema * Acute infectious disease * Acute respiratory illness
Where this trial is running
Cambridge, Cambridgeshire
- Royal Papworth Hospital — Cambridge, Cambridgeshire, United Kingdom (Recruiting)
Study contacts
- Principal investigator: Dariusz Wozniak, MD, PhD — Royal Papworth Hospital NHS Foundation Trust
- Study coordinator: Dariusz Wozniak, MD, PhD
- Email: dariusz.wozniak@nhs.net
- Phone: 01223639619
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.