New vibrating device aims to make mucus clearance easier for lung disease patients
NCT ID NCT06801327
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tests whether a new device called Simeox, which uses gentle vibrations to loosen mucus without forced breathing, works better than standard chest physiotherapy for people with bronchiectasis. Forty adults with stable disease will try both methods in a crossover design. Researchers will measure airway resistance, breathing rate, oxygen levels, and how much mucus is cleared.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Simeox device (respiratory physiotherapy device that uses gentle vibrations to help clear mucus without forced breathing)
- What this could lead to
- If Simeox works better than standard therapy, it could offer a more comfortable and effective way for people with bronchiectasis to clear mucus and improve breathing.
- What could go wrong
- This is a small, early-stage study (40 people) comparing two techniques, not testing a new drug. Results may not apply to all patients, and the device might not prove superior to existing methods.
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 40 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Dec 2024
- 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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18 years and older
- 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: * Patients with a diagnosis of bronchiectasis not due to cystic fibrosis who are not hospitalized. * Age ≥ 18 years. * Evidence of bronchiectasis in at least one lung lobe from a chest CT scan performed within the 10 years prior to enrollment. * Absence of exacerbations in the 28 days preceding enrollment. * Sputum producers with volumes less than or equal to 200 mL/day. * Under treatment with optimized standard therapy for bronchiectasis that has been stable for at least one year, with no changes in the 28 days prior to enrollment. * Eligible for and/or already undergoing respiratory physiotherapy. * Signed informed consent. Exclusion Criteria: * Diagnosis of COPD or bronchial asthma interpreted as primary and predominant diseases compared to bronchiectasis. * Presence of tracheostomy. * History of significant hemoptysis (≥300 mL of blood) or requiring embolization or blood transfusions in the 4 weeks preceding enrollment. * Hemodynamic instability (mean arterial pressure \< 65 mmHg, heart rate \> 110 bpm). * Undrained pneumothorax (evident on chest X-ray, deemed not worthy of pleural drainage according to standard clinical-assistance pathways and thus subjected to follow-up). * Women who are pregnant or breastfeeding.
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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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Respiratory and Critical Care Unit, IRCCS Azienda Ospedaliera-Universitaria di Bologna
RECRUITINGBologna, Bologna, 40138, Italy
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