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

NCT06956742 | Recruiting

• 1 other identifier: DEFLA-DYSPNEA
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

Brief Summary

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

Chronic Obstructive Pulmonary Disease (COPD)

Keywords

COPD; Chronic obstructive pulmonary disease; Intermittent intrapulmonary deflation; Dypsnea; Exercise

Outcome Measures

Primary Outcomes (1)

• Sensory dimension of dyspnea

  The sensory dimension of dyspnea will be assessed using French version of the Multidimensional Dyspnea Profile questionnaire, taking into account the last 30 seconds of effort during the 6-minute walk test to complete the questionnaire. This self-administered questionnaire can yield scores ranging from 0 to 10, with higher scores indicating a greater sensory dimension of dyspnea. The established minimal clinically important difference for this outcome is 2 points.

  Day 8 (after seven days of intervention)

Secondary Outcomes (63)

• Functional exercise capacity - Six-minute walk test

  Day 8 (after seven days of intervention).

• Affective dimension of dyspnea

  Day 8 (after seven days of intervention).

• Intensity of dyspnea

  Day 8 (after seven days of intervention).

• Intensity of lower limb fatigue

  Day 8 (after seven days of intervention).

• Respiratory function - Forced expiratory volume in 1 second

  Day 8 (after seven days of intervention).

Study Arms (2)

Active intermittent intrapulmonary deflation

EXPERIMENTAL

One week home-based treatment period.

Device: Active intermittent intrapulmonary deflation.

Placebo intermittent intrapulmonary deflation

PLACEBO COMPARATOR

One week home-based treatment period.

Device: Placebo intermittent intrapulmonary deflation.

Interventions

Active intermittent intrapulmonary deflation. DEVICE

Intermittent intrapulmonary deflation sessions will be performed using the SIMEOX device (SIMEOX, PhysioAssist, Aix-en-Provence, France), which will be delivered to the patient's home by a home healthcare provider. The device power setting (25%, 50%, 75%, or 100%) will be individualized according to the parameters determined during the familiarization visit by a trained physiotherapist. Patients will be instructed to perform tidal volume inspirations followed by passive expirations into the device through a mouthpiece, up to their maximal tolerance. The device will be activated by the patient during expiration using a manual remote control. Each device usage cycle consists of 10 expirations, with oscillations generated at 12 Hz during the first 8 cycles and at 6 Hz during the last 2 cycles. Rest periods will be allowed during the session, and a mandatory pause will be imposed every 10 expirations. The session duration is fixed at 20 minutes, with patients performing one session in the

Active intermittent intrapulmonary deflation

Placebo intermittent intrapulmonary deflation. DEVICE

Placebo intermittent intrapulmonary deflation sessions will be performed using the SIMEOX device (SIMEOX, PhysioAssist, Aix-en-Provence, France), which will be delivered to the patient's home by a home healthcare provider. Due to the physiological mechanism of action of the device (intermittent negative pressure with increasing intensity, inversely proportional to airflow resistance), it is assumed that device use under placebo conditions will be infra-therapeutic. To ensure this, the device will be set to the same setting as the active intermittent intrapulmonary deflation session but an intentional air leak will be introduced into the circuit at the device's output (not visible to the participant) to prevent the generated negative pressure from exceeding t The validity of this placebo condition will be confirmed through bench tests. All other conditions will remain identical to the active intermittent intrapulmonary deflation sessions. Patients will be instructed to perform tidal vo

Placebo intermittent intrapulmonary deflation

Eligibility Criteria

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

You may qualify if:

• Age \> 18 years;
• COPD stage GOLD II to IV;
• Completion of a pulmonary rehabilitation program within the last 6 months;
• minute walk test \< 350 meters before and/or after completing the pulmonary; rehabilitation program;
• mMRC dyspnea scale ≥ 2;
• Pulmonary hyperinflation (ratio between residual volume to total lung capacity superior to 50%, and either total lung capacity superior to 130% or functional residual capacity superior to 130%);
• With or without oxygen supplementation;
• Stable condition (no exacerbation or change in treatment in the last 4 weeks);
• Naïve to intermittent intrapulmonary deflation.
• Regulatory criteria (social security affiliation; adult patient who has read and understood the information letter and signed the informed consent form).
• Pregnant women or likely to be;
• Patients under guardianship or curatorship;
• Inability to consent;
• Primary diagnosis of another chronic obstructive respiratory disease such as asthma or primary bronchiectasis;
• Orthopedic, neurological, vascular, or neuromuscular conditions that limit walking or require walking aids;

You may not qualify if:

• Withdrawal of consent;
• Acute COPD exacerbation between visits or onset of cardiorespiratory instability;
• Use of an electrical mechanical device for airway clearance during the study period (in-exsufflator, high-frequency chest oscillation, etc.).

Sponsors & Collaborators

• ADIR Association: lead
• PhysioAssist: collaborator

Study Sites (1)

ADIR Association

Rouen, Normandy, 76000, France

RECRUITING

Related Publications (1)

• Ekstrom MP, Bornefalk H, Skold CM, Janson C, Blomberg A, Bornefalk-Hermansson A, Igelstrom H, Sandberg J, Sundh J. Minimal Clinically Important Differences and Feasibility of Dyspnea-12 and the Multidimensional Dyspnea Profile in Cardiorespiratory Disease. J Pain Symptom Manage. 2020 Nov;60(5):968-975.e1. doi: 10.1016/j.jpainsymman.2020.05.028. Epub 2020 Jun 6.

  PMID: 32512047 BACKGROUND

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Motor Activity

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Behavior

Study Officials

• Tristan Bonnevie, PhD

  Association ADIR

  PRINCIPAL INVESTIGATOR

• Francis-Edouard Gravier, PhD

  ADIR Association

  STUDY CHAIR

• Antoine Cuvelier, Professor

  ADIR Association

  STUDY CHAIR

• Jean-François Muir, Professor

  ADIR Association

  STUDY CHAIR

• Astrid Vanheule, Msc student

  ADIR Association

  STUDY CHAIR

Central Study Contacts

Tristan Bonnevie, PhD

CONTACT

0235592970; t.bonnevie@adir-hautenormandie.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Statistician.
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Single-center, randomized controlled, prospective, two-arm crossover trial with concealed allocation and double-blinding (participants and evaluators). This study will be accompanied by a pre-planned ancillary study designed to evaluate the acute effects of using the intermittent intrapulmonary deflation device on the same outcomes, based on the initial randomization sequence at the first visit (see Study Description section). Consequently, this ancillary study is a single-center, randomized controlled, prospective, parallel trial with concealed allocation and double blinding (participants and evaluators).

Study Record Dates

• First Submitted: April 24, 2025
• First Posted: May 4, 2025
• Study Start: June 1, 2025
• Primary Completion (Estimated): February 28, 2028
• Study Completion (Estimated): February 28, 2028
• Last Updated: November 19, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP
• Time Frame: Statistical analysis plan will be made available prior to the commencement of any statistical analysis. Individual participant data will be made available after publication.
• Access Criteria: Data will be made available upon request, for research purpose. Request should be send to Dr T. Bonnevie (t.bonnevie@adir-hautenormandie.com).

Locations

FR (1)