New Lung-Clearing device could ease breathing for kids with cystic fibrosis
NCT ID NCT04084041
First seen Jun 25, 2026 · Last updated Jun 26, 2026 · Updated 1 time
Summary
This study tested a new device called Simeox, which helps clear mucus from the lungs, in 40 children with cystic fibrosis aged 8 to 18. Each child used the device for one month and standard chest physiotherapy for another month, in random order. The goal was to see if the device improves lung function and quality of life compared to the usual therapy.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Simeox airway clearance device
- What this could lead to
- If it works, this could offer a more effective or easier way for children with cystic fibrosis to clear mucus from their lungs, potentially improving breathing and reducing infections.
- What could go wrong
- This is a small, early-stage crossover study with only 40 children. The device may not prove better than standard physiotherapy, and results may not apply to all patients. No serious risks are expected, but the device may be uncomfortable or hard to use.
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
-
40 people
The number who actually took part.
- Started
-
Sep 2019
- Finished
-
Feb 2021
- Lead sponsor
-
A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
8 to 18 years
- 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 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: * Subject and his or her legally appointed and authorized representative will agree for treatment with Simeox technology * willing and able to cooperate and learn new technic of drainage. * age 8-18 years, on the date of admission to hospital. * confirmed diagnosis of CF as determined by the investigator. * able to perform pulmonary tests Exclusion Criteria: History of any illness or any clinical condition that, in the opinion of the investigator, might confound the cooperation or the results of the study or pose an additional risk to the subject in using study technology. This includes, but is not limited to, the following: * contraindications to bronchial chest physiotherapy * hemoptysis * pneumothorax * heart disease * recent chest surgery * recent chest injury * history of lung transplantation
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Airway clearance impairment are added.
Genom att skicka in godkänner du våra Användarvillkor
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.
Contacts and locations
Locations
-
IMiD
Warsaw, Poland
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Triple therapy under the microscope: does it transform cystic fibrosis care?
- Can a virus tip the balance? unraveling lung bacteria in cystic fibrosis
- Could a 'robotic cough' stop deadly pneumonia in ICU patients?
- Video game coaching may help kids master cough machines
- Hidden struggles in kids with cystic fibrosis: new study aims to uncover the full picture
- Global experts aim to settle debate on ICU airway care