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

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.

Study Overview

• Status: Recruiting
• Conditions: Respiratory Disease; Excessive Dynamic Airway Collapse; Tracheobronchomalacia; Excessive Central Airways Collapse
• Intervention / Treatment: Device: Use of portable CPAP

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Dariusz Wozniak, MD, PhD; Phone Number: 01223639619; Email: dariusz.wozniak@nhs.net
• Study Contact Backup: Name: Victoria EA Stoneman, BSc, PhD; Phone Number: 01223639865; Email: victoria.stoneman@nhs.net

Study Locations

• United Kingdom
  • Cambridgeshire
    • Cambridge, Cambridgeshire, United Kingdom, CB2 0AY
      • Recruiting
      • Royal Papworth Hospital
      • Contact: Vikki Hughes, PhD; Phone Number: 01223 639678; Email: victoria.hughes1@nhs.net
      • Contact: Victoria EA Stoneman, PhD; Phone Number: 01223639865; Email: victoria.stoneman@nhs.net
      • Principal Investigator: Dariusz Wozniak

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: No Portable CPAP; Patients continue life as normal without portable CPAP
Experimental: Use of portable CPAP; Patients use portable CPAP during periods of exercise	Device: Use of portable CPAP; Patients use portable CPAP during exercise

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Degree of dyspnoea pre and post shuttle walk test	dyspnoea will be measured using the Borg scale	During shuttle walk test performed after four weeks of using portable CPAP

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Activity levels with and without portable CPAP	Activity levels based on pedometer readings	30 day
Average daily usage of CPAP	Absolute hours of daily usage	30 days
Quality of life score	Respiratory-specific quality of life after use of portable CPAP using St George's Respiratory Questionnaire (scores range from 0 to 100, with higher scores indicating more limitations) and Severe Respiratory Insufficiency (SRI) questionnaire (score of 0 to 100 represents the worst to best health-related quality of life)	4 weeks
Feasibility of CPAP self-titration	Feasibility and efficacy of CPAP self-titration using Likert scale (range 1-5, higher scores indicate better outcomes), change in CPAP pressure levels and distance walked whilst using portable CPAP	4 weeks
participant perception of using portable CPAP	Participant acceptance of using CPAP and its perceived impact on activity level: assessed using a Likert scale ((range 1-5, higher scores indicate better outcomes)	4 weeks
Correlation between severity of ECAC disease and response to portable CPAP	Correlation between severity of ECAC disease (as determined by FRI measurements in CT scans) and response to portable CPAP	4 weeks

Collaborators and Investigators

• Sponsor: Papworth Hospital NHS Foundation Trust
• Investigators: Principal Investigator: Dariusz Wozniak, MD, PhD, Royal Papworth Hospital NHS Foundation Trust

Study record dates

Study Major Dates

• Study Start (Actual): July 27, 2023
• Primary Completion (Estimated): December 31, 2023
• Study Completion (Estimated): July 31, 2024

Study Registration Dates

• First Submitted: August 24, 2023
• First Submitted That Met QC Criteria: October 3, 2023
• First Posted (Estimated): October 9, 2023

Study Record Updates

• Last Update Posted (Estimated): October 9, 2023
• Last Update Submitted That Met QC Criteria: October 3, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Congenital Abnormalities; Bronchial Diseases; Musculoskeletal Diseases; Connective Tissue Diseases; Musculoskeletal Abnormalities; Cartilage Diseases; Tracheal Diseases; Shock; Respiration Disorders; Respiratory Tract Diseases; Tracheobronchomalacia; Bronchomalacia
• Other Study ID Numbers: P03038

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No