Efficacy of the Simeox<sup>®</sup> Airway Clearance Technology in the Homecare Treatment of Children with Clinically Stable Cystic Fibrosis: A Randomized Controlled Trial
Background: Cystic fibrosis (CF) patients require regular airway clearance therapy (ACT). The aim of this study was to evaluate homecare therapeutic effects of a new ACT (Simeox<sup>®</sup>) added to the optimal standard of care, including home chest physiotherapy, in the treatment of cl...
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MDPI AG
2023-01-01
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| Series: | Children |
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| Online Access: | https://www.mdpi.com/2227-9067/10/2/204 |
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| author | Dorota Sands Katarzyna Walicka-Serzysko Justyna Milczewska Magdalena Postek Natalia Jeneralska Aleksandra Cichocka Ewa Siedlecka Urszula Borawska-Kowalczyk Laurent Morin |
| author_facet | Dorota Sands Katarzyna Walicka-Serzysko Justyna Milczewska Magdalena Postek Natalia Jeneralska Aleksandra Cichocka Ewa Siedlecka Urszula Borawska-Kowalczyk Laurent Morin |
| author_sort | Dorota Sands |
| collection | DOAJ |
| description | Background: Cystic fibrosis (CF) patients require regular airway clearance therapy (ACT). The aim of this study was to evaluate homecare therapeutic effects of a new ACT (Simeox<sup>®</sup>) added to the optimal standard of care, including home chest physiotherapy, in the treatment of clinically stable children. Methods: Forty pediatric CF patients (8–17 years old) with stable disease were randomized 1:1 in a single-center, prospective, open-label, cross-over trial into two groups: with or without Simeox<sup>®</sup>. Lung function (impulse oscillometry, spirometry, body plethysmography, multi-breath nitrogen washout) results, health-related quality of life, and safety were assessed during the study after 1 month of therapy at home. Results: A significant decrease in proximal airway obstruction (as supported by improvement in airway resistance at 20 Hz (R20Hz) and maximum expiratory flow at 75% of FVC (MEF75)) compared to the control group was observed after 1 month of therapy with the device. Lung-clearance index was stable in the study group, while it worsened in the control group. In addition, the device group demonstrated a significant increase in the Cystic Fibrosis Questionnaire—Revised (CFQ-R) physical score. No side effects were identified during the study. Conclusions: Simeox<sup>®</sup> may improve drainage of the airways in children with clinically stable CF and could be an option in chronic treatment of the disease. |
| first_indexed | 2024-03-11T08:59:54Z |
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| language | English |
| last_indexed | 2024-03-11T08:59:54Z |
| publishDate | 2023-01-01 |
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| record_format | Article |
| series | Children |
| spelling | doaj.art-5f434dab61e8497bbff3d9e0ce2952bc2023-11-16T19:47:28ZengMDPI AGChildren2227-90672023-01-0110220410.3390/children10020204Efficacy of the Simeox<sup>®</sup> Airway Clearance Technology in the Homecare Treatment of Children with Clinically Stable Cystic Fibrosis: A Randomized Controlled TrialDorota Sands0Katarzyna Walicka-Serzysko1Justyna Milczewska2Magdalena Postek3Natalia Jeneralska4Aleksandra Cichocka5Ewa Siedlecka6Urszula Borawska-Kowalczyk7Laurent Morin8Cystic Fibrosis Department, Institute of Mother and Child, 01-211 Warsaw, PolandCystic Fibrosis Department, Institute of Mother and Child, 01-211 Warsaw, PolandCystic Fibrosis Department, Institute of Mother and Child, 01-211 Warsaw, PolandCystic Fibrosis Department, Institute of Mother and Child, 01-211 Warsaw, PolandCystic Fibrosis Centre, Pediatric Hospital, 05-092 Dziekanow Lesny, PolandCystic Fibrosis Centre, Pediatric Hospital, 05-092 Dziekanow Lesny, PolandCystic Fibrosis Centre, Pediatric Hospital, 05-092 Dziekanow Lesny, PolandCystic Fibrosis Department, Institute of Mother and Child, 01-211 Warsaw, PolandPhysioAssist, 34090 Montpellier, FranceBackground: Cystic fibrosis (CF) patients require regular airway clearance therapy (ACT). The aim of this study was to evaluate homecare therapeutic effects of a new ACT (Simeox<sup>®</sup>) added to the optimal standard of care, including home chest physiotherapy, in the treatment of clinically stable children. Methods: Forty pediatric CF patients (8–17 years old) with stable disease were randomized 1:1 in a single-center, prospective, open-label, cross-over trial into two groups: with or without Simeox<sup>®</sup>. Lung function (impulse oscillometry, spirometry, body plethysmography, multi-breath nitrogen washout) results, health-related quality of life, and safety were assessed during the study after 1 month of therapy at home. Results: A significant decrease in proximal airway obstruction (as supported by improvement in airway resistance at 20 Hz (R20Hz) and maximum expiratory flow at 75% of FVC (MEF75)) compared to the control group was observed after 1 month of therapy with the device. Lung-clearance index was stable in the study group, while it worsened in the control group. In addition, the device group demonstrated a significant increase in the Cystic Fibrosis Questionnaire—Revised (CFQ-R) physical score. No side effects were identified during the study. Conclusions: Simeox<sup>®</sup> may improve drainage of the airways in children with clinically stable CF and could be an option in chronic treatment of the disease.https://www.mdpi.com/2227-9067/10/2/204cystic fibrosischest physiotherapyhomecare therapypulmonary function testSimeox |
| spellingShingle | Dorota Sands Katarzyna Walicka-Serzysko Justyna Milczewska Magdalena Postek Natalia Jeneralska Aleksandra Cichocka Ewa Siedlecka Urszula Borawska-Kowalczyk Laurent Morin Efficacy of the Simeox<sup>®</sup> Airway Clearance Technology in the Homecare Treatment of Children with Clinically Stable Cystic Fibrosis: A Randomized Controlled Trial Children cystic fibrosis chest physiotherapy homecare therapy pulmonary function test Simeox |
| title | Efficacy of the Simeox<sup>®</sup> Airway Clearance Technology in the Homecare Treatment of Children with Clinically Stable Cystic Fibrosis: A Randomized Controlled Trial |
| title_full | Efficacy of the Simeox<sup>®</sup> Airway Clearance Technology in the Homecare Treatment of Children with Clinically Stable Cystic Fibrosis: A Randomized Controlled Trial |
| title_fullStr | Efficacy of the Simeox<sup>®</sup> Airway Clearance Technology in the Homecare Treatment of Children with Clinically Stable Cystic Fibrosis: A Randomized Controlled Trial |
| title_full_unstemmed | Efficacy of the Simeox<sup>®</sup> Airway Clearance Technology in the Homecare Treatment of Children with Clinically Stable Cystic Fibrosis: A Randomized Controlled Trial |
| title_short | Efficacy of the Simeox<sup>®</sup> Airway Clearance Technology in the Homecare Treatment of Children with Clinically Stable Cystic Fibrosis: A Randomized Controlled Trial |
| title_sort | efficacy of the simeox sup r sup airway clearance technology in the homecare treatment of children with clinically stable cystic fibrosis a randomized controlled trial |
| topic | cystic fibrosis chest physiotherapy homecare therapy pulmonary function test Simeox |
| url | https://www.mdpi.com/2227-9067/10/2/204 |
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