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COMPLETEDNA

Efficacy of Simeox Airway Clearance Therapy in Children With Cystic Fibrosis

Efficacy of the Simeox Airway Clearance Technology in the Treatment of Children With Clinically Stable Cystic Fibrosis- Cross-over Study With Randomization

NCT04084041•Physio-Assist

View on ClinicalTrials.gov

Summary

Chest physiotherapy plays a crucial role in treatment of lung disease in cystic fibrosis (CF). New airway clearance techniques (ACTs) adapted to individual needs are still being sought to achieve the best effect of airway clearance. The primary aim of this study is to assess the efficacy of a new ACT (Simeox) on pulmonary function in children with CF. 40 CF patients with stable respiratory function will be randomized 1:1 to Simeox or conventional chest physiotherapy (CCPT) therapy (control group) and treated at home during 1 month. After a short washout period, patients will be treated at home onto the alternative treatment for 1 month (crossover design). Lung function, quality of life, pulmonary exacerbation and safety will be evaluated at 1 month for each therapy period.

Eligibility

Age

8 - 18 years

Sex

ALL

Healthy Volunteers

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

Locations (1)

IMiD

Warsaw, Poland

Key Dates

Start Date

September 10, 2019

Primary Completion Date

January 31, 2021

Completion Date

February 15, 2021

Last Updated

September 24, 2025

Enrollment

ACTUAL participants

Conditions

Cystic Fibrosis in ChildrenAirway Clearance Impairment

Interventions

Simeox

DEVICE

CCPT

OTHER

Outcome Comparisons of Vibratory Airway Clearance Devices

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RECRUITINGNA

Effects of Ventilator Hyperinflation Versus Vibrocompression in Mechanically Ventilated Patients

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 24, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Efficacy of Simeox Airway Clearance Therapy in Children With Cystic Fibrosis

Inclusion Criteria

Exclusion Criteria

Outcome Comparisons of Vibratory Airway Clearance Devices

Effects of Ventilator Hyperinflation Versus Vibrocompression in Mechanically Ventilated Patients

Feasibility of Cough Monitoring in Children

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