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

NCT06072872 | Unknown

• 1 other identifier: P03038
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Distance achieved in incremental shuttle walk test with and without portable CPAP

  Distance achieved in incremental shuttle walk test with and without portable CPAP after using portable CPAP

  After using portable CPAP for four weeks

Secondary Outcomes (1)

• Degree of dyspnoea pre and post shuttle walk test

  During shuttle walk test performed after four weeks of using portable CPAP

Other Outcomes (6)

• Activity levels with and without portable CPAP

  30 day

• Average daily usage of CPAP

  30 days

• Quality of life score

  4 weeks

Study Arms (2)

No Portable CPAP

NO INTERVENTION

Patients continue life as normal without portable CPAP

Use of portable CPAP

EXPERIMENTAL

Patients use portable CPAP during periods of exercise

Device: Use of portable CPAP

Interventions

Use of portable CPAP DEVICE

Patients use portable CPAP during exercise

Use of portable CPAP

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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)
• 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.
• Age over 18 years
• Able to give informed consent -

You may not qualify if:

• 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

Sponsors & Collaborators

• Papworth Hospital NHS Foundation Trust: lead

Study Sites (1)

Royal Papworth Hospital

Cambridge, Cambridgeshire, CB2 0AY, United Kingdom

RECRUITING

MeSH Terms

Conditions

Respiration Disorders; Tracheobronchomalacia

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases; Cartilage Diseases; Musculoskeletal Diseases; Bronchial Diseases; Tracheal Diseases; Musculoskeletal Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Connective Tissue Diseases; Skin and Connective Tissue Diseases

Study Officials

• Dariusz Wozniak, MD, PhD

  Royal Papworth Hospital NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dariusz Wozniak, MD, PhD

CONTACT

01223639619; dariusz.wozniak@nhs.net

Victoria EA Stoneman, BSc, PhD

CONTACT

01223639865; victoria.stoneman@nhs.net

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: Prospective interventional, with first period without use of study device, followed with second period using study device

Study Record Dates

• First Submitted: August 24, 2023
• First Posted: October 10, 2023
• Study Start: July 27, 2023
• Primary Completion: December 31, 2023
• Study Completion: July 31, 2024
• Last Updated: October 10, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)