Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Device | Experimental | Device group |
|
| Conventional chest physiotherapy | Active Comparator | Control group |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Simeox | Device | Airway clearance device |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change in total lung resistance | Evolution of R5hz - Impulse Oscillometry (IOS) from baseline | 1 month |
| Measure | Description | Time Frame |
|---|---|---|
| Change in central lung resistance | Evolution of R20hz - Impulse Oscillometry (IOS) from baseline | 1 month |
| Change in peripheral lung resistance | Evolution of R5-20hz - Impulse Oscillometry (IOS) from baseline |
Not provided
Inclusion Criteria:
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:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Dorota Sands, MD, PhD | IMiD | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| IMiD | Warsaw | Poland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36832333 | Result | Sands D, Walicka-Serzysko K, Milczewska J, Postek M, Jeneralska N, Cichocka A, Siedlecka E, Borawska-Kowalczyk U, Morin L. Efficacy of the Simeox(R) Airway Clearance Technology in the Homecare Treatment of Children with Clinically Stable Cystic Fibrosis: A Randomized Controlled Trial. Children (Basel). 2023 Jan 23;10(2):204. doi: 10.3390/children10020204. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| CCPT |
| Other |
Conventional chest physiotherapy |
|
| 1 month |
| Change in total lung reactance | Evolution of X5hz -Impulse Oscillometry (IOS) from baseline | 1 month |
| Change in area of reactance (AX) | Evolution of AX -Impulse Oscillometry (IOS) from baseline | 1 month |
| Change in total score of Cystic Fibrosis Questionnaire-Revised (CFQ-R) | Evolution of CFQ-R total score (0-100) from baseline | 1 month |
| Change in respiratory domain score of Cystic Fibrosis Questionnaire Revised (CFQ-R) questionnaire | Evolution of respiratory score (0-100) of CFQ-R from baseline | 1 month |
| Change in Forced Expiratory Volume in 1 second (FEV1) | Evolution of FEV1 (spirometry) from baseline | 1 month |
| Change in Forced Vital Capacity (FVC) | Evolution of FVC (spirometry) from baseline | 1 month |
| Change in Residual Volume (RV) | Evolution of RV (body plethysmography) from baseline | 1 month |
| Change in Maximal Expiratory Flow (MEF) at 25, 50 and 75% of expired volume | Evolution of MEF 25, 50 and 75 (spirometry) from baseline | 1 month |
| Change in Mean Mid Expiratory Flow (MMEF) | Evolution of MMEF (spirometry) from baseline | 1 month |
| Change in lung clearance index (LCI) | Evolution of LCI with Nitrogen multiple breath washout (N2MBW) tests from baseline | 1 month |
| Pulmonary exacerbation | Rate of pulmonary exacerbation | 1 month |
| Adverse events | Rate of adverse events related or not related to intervention | 1 month |