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New vibrating device aims to make mucus clearance easier for lung disease patients

NCT ID NCT06801327

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

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

About 40 people

The number the study aims to enrol. It can still change while the study runs.

Started

Dec 2024

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

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

18 years and older

Sex

Anyone

Healthy volunteers

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

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.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • Respiratory and Critical Care Unit, IRCCS Azienda Ospedaliera-Universitaria di Bologna

    RECRUITING

    Bologna, Bologna, 40138, Italy

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