Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT06956742

Intermittent Intrapulmonary Deflation and Dyspnea Following Exercise in People With Chronic Obstructive Pulmonary Disease

Led by ADIR Association · Updated on 2025-11-19

33

Participants Needed

1

Research Sites

143 weeks

Total Duration

On this page

Sponsors

A

ADIR Association

Lead Sponsor

P

PhysioAssist

Collaborating Sponsor

AI-Summary

What this Trial Is About

Chronic obstructive pulmonary disease is a long-term lung condition that causes breathing difficulties. People living with this disease often feel short of breath, especially during physical activity, which can make daily tasks more challenging. This breathlessness is partly caused by mucus accumulation within the airways and air getting trapped in the lungs. Both of these reduce the amount of fresh air that can enter with each breath and increase the effort required to breathe. To manage symptoms, people with chronic obstructive pulmonary disease may use medications, oxygen therapy, or be referred to pulmonary rehabilitation programs. These programs often include exercise training, self-management strategies, and airway clearance techniques. While chest physiotherapists typically guide patients in these techniques, certain medical devices can also help individuals manage their condition independently at home. One such device uses a method called intermittent intrapulmonary deflation, which involves applying gentle pressure changes through a mouthpiece to help loosen mucus and release trapped air from the lungs. Although some individuals already use this kind of device as part of their daily care, more scientific evidence is needed to determine whether the improvements in airway clearance and reduced air trapping actually lead to measurable relief of breathlessness. The goal of this clinical trial is to find out whether this type of medical device designed to remove airway mucus and trapped air in the lungs (using intermittent intrapulmonary deflation) can help reduce breathlessness (dyspnea) after physical activity in people with COPD. The main questions this study aims to answer are: * Does using the device at home for one week reduce the intensity of breathlessness after walking? * Does it also improve walking distance, reduce the feeling of muscle fatigue, or increase satisfaction with the airway clearance method? Researchers will compare the active device to a placebo device that looks and feels identical but does not deliver the active treatment. This comparison will help determine whether the observed effects are due to the device itself or other factors such as expectations or chance. Participants in this study will be adults diagnosed with moderate to very severe chronic obstructive pulmonary disease. All participants must have recently completed a pulmonary rehabilitation program, continue to experience breathlessness while walking, and show signs of lung hyperinflation (when air remains trapped in the lungs). People will not be included if they have other serious health conditions that could make walking difficult or unsafe, or if they have any contraindications to using the device. Participants who agree to participante in the study will: * Attend a visit at the pulmonary rehabilitation center for baseline testing and to learn how to use the device; * Be randomly assigned to use either the active device or the placebo device at home for 7 days; * Return to the center for walking tests, lung function tests, and questionnaires about breathing and fatigue; * After a one-week break, use the device with alternative settings (the one not used in the first phase) for another 7 days; * Complete a final visit at the end of the study to repeat the same tests. Participants will also be invited to take part in an ancillary study during their first clinic visit to examine how a single session with the device affects breathlessness immediately after walking. This research will help determine whether this non-pharmacological, device-based method of clearing mucus and reducing trapped air can bring meaningful improvement in breathlessness for people with chronic obstructive pulmonary disease, especially when used at home. If effective, it may offer a simple and convenient way to help people breathe more comfortably during everyday activities. Participants will receive compensation for their time and travel.

CONDITIONS

Official Title

Intermittent Intrapulmonary Deflation and Dyspnea Following Exercise in People With Chronic Obstructive Pulmonary Disease

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age over 18 years
  • Diagnosed with COPD stage GOLD II to IV
  • Completed a pulmonary rehabilitation program within the last 6 months
  • Six-minute walk test less than 350 meters before or after pulmonary rehabilitation
  • Breathlessness score of 2 or higher on the mMRC dyspnea scale
  • Evidence of lung hyperinflation (residual volume to total lung capacity ratio over 50%, and total lung capacity or functional residual capacity over 130%)
  • Stable condition with no exacerbations or treatment changes in the last 4 weeks
  • Not previously treated with intermittent intrapulmonary deflation
  • Affiliated with social security and able to provide informed consent
Not Eligible

You will not qualify if you...

  • Pregnant or likely to become pregnant
  • Under legal guardianship or curatorship
  • Unable to provide consent
  • Primary diagnosis of another chronic respiratory disease such as asthma or bronchiectasis
  • Orthopedic, neurological, vascular, or neuromuscular conditions limiting walking or requiring walking aids
  • Severe or unstable heart disease (including uncontrolled arrhythmias, severe heart failure, recent heart attack, or unstable angina)
  • Need for assisted breathing such as ventilatory support with tubes or masks
  • Hemodynamic instability
  • Pneumothorax within the last 3 months
  • Recent lung or upper airway surgery within the last month
  • Preparing for thoracic surgery like lung volume reduction or transplantation
  • Use of electrical mechanical airway clearance devices during the study
  • Active cancer
  • Severe recent hemoptysis within 3 months
  • Severe tracheomalacia
  • Withdrawal of consent
  • Acute COPD exacerbation or cardiorespiratory instability during the study

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

ADIR Association

Rouen, Normandy, France, 76000

Actively Recruiting

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Research Team

T

Tristan Bonnevie, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

CROSSOVER

Primary Purpose

SUPPORTIVE_CARE

Number of Arms

2

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