Chest vibrations may boost lung sample collection
NCT ID NCT07751705
First seen Aug 07, 2026 · Last updated Aug 20, 2026 · Updated 2 times
Summary
This trial tests whether a device that sends gentle vibrations through the chest can help people with COPD cough up more sputum (mucus) during a standard collection procedure. Each participant undergoes the procedure twice—once with the device and once without—to compare the amount of sample obtained. The goal is to see if the device improves sample yield, which could enhance research on lung diseases.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- A vibroacoustic device applied to the chest during sputum collection
- What this could lead to
- If effective, this device could improve sputum collection in COPD, aiding research and diagnosis of lung diseases.
- What could go wrong
- The trial is small (20 participants) and early, so results may not apply broadly. The device may not increase sputum yield or could cause discomfort.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 20 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Aug 2026
- Expected to finish
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Dec 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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40 to 70 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Able and willing to give written informed consent. 2. Male and female participants, aged 40-70 years, inclusive. Women of childbearing potential (i.e. not post-menopausal, defined as amenorrhoeic for at least 12 months, and without documented surgical sterilization such as hysterectomy, bilateral oophorectomy, or tubal ligation) must not be pregnant, as confirmed by a negative urine pregnancy test prior to each sputum induction procedure, and must not be breastfeeding. 3. Diagnosis of COPD based on post-bronchodilator spirometry, defined as FEV1/FVC \< 0.70, consistent with GOLD criteria. 4. FEV1 between 50% and 80% of predicted (post-bronchodilator). 5. Body mass index between 18 and 38 kg/m2 6. Subgroup "Current Smokers": current smoking with at least 15 cigarettes per day over the past 12 months and a cumulative smoking history of at least 10 pack-years, confirmed by a positive urine cotinine test at screening. 7. Subgroup "Ex-smokers": no smoking for at least one year prior to screening and a cumulative smoking history of at least 10 pack-years, confirmed by a negative urine cotinine test at screening Exclusion Criteria: 1. Any clinically relevant disease or condition which, in the opinion of the investigator, may significantly compromise participant safety, affect study outcomes, or prevent adherence to the protocol. Explicitly excluded is cystic fibrosis or interstitial lung disease. 2. Any condition that, as judged by the investigator, constitutes a contraindication or safety concern for the application of vibroacoustic chest therapy. This includes, but is not limited to: * Any implanted or external electronic-mechanical device in the thoracic projection area (e.g. cardiac pacemaker, implantable cardioverter-defibrillator, cardiac assist devices, implantable drug delivery pumps, neurostimulators) * Coronary heart disease with coronary stents or history of percutaneous coronary intervention or coronary artery bypass grafting * Mechanical heart valve prosthesis * Aortic stent graft or thoracic endovascular implant * Unstable angina pectoris or acute coronary syndrome within the past 6 months * Clinically significant cardiac arrhythmia requiring treatment (e.g. uncontrolled atrial fibrillation, ventricular tachycardia) * Known large pulmonary bullae (\>1 cm) or history of spontaneous pneumothorax * Unstable rib fractures or thoracic vertebral fractures * Active haemoptysis or known high risk of pulmonary haemorrhage * Therapeutic anticoagulation or known coagulation disorder with increased bleeding risk * Active thoracic malignancy * Thoracic surgery within the past 6 month 3. Initiation or discontinuation of mucolytic or expectorant agents (e.g., N-acetylcysteine, ambroxol) within 14 days prior to Visit 1 or between study visits. Participants on stable chronic mucolytic therapy (unchanged regimen for at least 4 weeks prior to Visit 1) may be enrolled provided they maintain the same regimen throughout the study. 4. Treatment with systemic corticosteroids or biological therapies within 6 months prior to screening 5. Treatment with antibiotics within 2 months prior to screening 6. Lower respiratory tract infection within 4 weeks prior to screening 7. Upper respiratory tract infection within 2 weeks prior to screening 8. History of drug or alcohol abuse within 12 months prior to screening 9. Participation in a clinical trial involving an investigational medicinal product within 6 months prior to screening 10. Any condition associated with an increased risk of non-compliance with study procedures (e.g. inability to hold the vibroacoustic emitters against the chest because of severe arthritis, neuromuscular disease, or other condition significantly limiting upper extremity function).
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Fraunhofer Institute for Toxicology and Experimental Medicine (ITEM), Department of Clinical Airway Research
RECRUITINGHanover, Lower Saxony, 30625, Germany
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