NCT06072872

Portable Continuous Positive Airways Pressure (CPAP) in Excessive Central Airway Collapse (ECAC) Study

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Papworth Hospital NHS Foundation Trust · Other Government
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study will investigate the role of a portable Continues Positive Airway Pressure device (pCPAP) in management of patients with symptomatic Excessive Central Airway Collapse (ECAC). ECAC is characterised by complete or partial collapse of central airways on exhalation. In some cases, this can cause persistent breathlessness and severely limited exercise capacity. Current treatment options for ECAC are very limited. Standard assistive breathing devices such as CPAP machines are sometimes used to relieve symptoms at night or at rest. This does not address breathlessness during activity which drives accumulation of disability over time. The main aims of this project are to assess the effect of a portable CPAP (pCPAP) device on exercise capacity and symptoms and evaluate the feasibility of wearing pCPAP at home during routine activities. Lightweight battery-powered portable CPAP devices have been recently developed to facilitate travel to remote areas by people with Obstructive Sleep Apnoea (OSA). Patients with ECAC can wear them during physical activity to prevent airway collapse but their potential benefits have not been evaluated in clinical trials. For this study, the investigators will recruit 20 patients with ECAC who will attend for two study visits 4-6 weeks apart in a single centre (The Royal Papworth Hospital). The primary outcome measure will be a shuttle walk test performed repeatedly with and without pCPAP in a randomised order. Secondary outcomes will include assessment of activity level, breathlessness, quality of life ,pCPAP usage and its acceptability. The study will evaluate a pragmatic way of CPAP titration and application. Previously acquired diagnostic baseline computed tomography (CT) scans will be analysed with a novel Functional Respiratory Imaging (FRI) tool. This software tool will enable retrospective reflections on the changes occurring within the lungs for patients with ECAC. This may help identify predictive features of potential pCPAP responders and inform future use.

Conditions

• Excessive Central Airways Collapse
• Respiratory Disease
• Tracheobronchomalacia
• Excessive Dynamic Airway Collapse

Interventions

Type	Name	Description
DEVICE	Use of portable CPAP	Patients use portable CPAP during exercise

Timeline

• Start date: 2023-07-27
• Primary completion: 2023-12-31
• Completion: 2024-07-31
• First posted: 2023-10-10
• Last updated: 2023-10-10

Locations

1 site across 1 country: United Kingdom