Efficacy of Simeox Airway Clearance Therapy in Children With Cystic Fibrosis
- Conditions
- Cystic Fibrosis in ChildrenAirway Clearance Impairment
- Interventions
- Device: SimeoxOther: CCPT
- Registration Number
- NCT04084041
- Lead Sponsor
- Physio-Assist
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 40
- 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
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Device Simeox Device group Conventional chest physiotherapy Simeox Control group Device CCPT Device group Conventional chest physiotherapy CCPT Control group
- Primary Outcome Measures
Name Time Method Change in total lung resistance 1 month Evolution of R5hz - Impulse Oscillometry (IOS) from baseline
- Secondary Outcome Measures
Name Time Method Pulmonary exacerbation 1 month Rate of pulmonary exacerbation
Change in total score of Cystic Fibrosis Questionnaire-Revised (CFQ-R) 1 month Evolution of CFQ-R total score (0-100) from baseline
Change in Forced Vital Capacity (FVC) 1 month Evolution of FVC (spirometry) from baseline
Change in Mean Mid Expiratory Flow (MMEF) 1 month Evolution of MMEF (spirometry) from baseline
Change in lung clearance index (LCI) 1 month Evolution of LCI with Nitrogen multiple breath washout (N2MBW) tests from baseline
Change in area of reactance (AX) 1 month Evolution of AX -Impulse Oscillometry (IOS) from baseline
Change in central lung resistance 1 month Evolution of R20hz - Impulse Oscillometry (IOS) from baseline
Change in Maximal Expiratory Flow (MEF) at 25, 50 and 75% of expired volume 1 month Evolution of MEF 25, 50 and 75 (spirometry) from baseline
Change in Forced Expiratory Volume in 1 second (FEV1) 1 month Evolution of FEV1 (spirometry) from baseline
Change in total lung reactance 1 month Evolution of X5hz -Impulse Oscillometry (IOS) from baseline
Change in Residual Volume (RV) 1 month Evolution of RV (body plethysmography) from baseline
Change in peripheral lung resistance 1 month Evolution of R5-20hz - Impulse Oscillometry (IOS) from baseline
Change in respiratory domain score of Cystic Fibrosis Questionnaire Revised (CFQ-R) questionnaire 1 month Evolution of respiratory score (0-100) of CFQ-R from baseline
Adverse events 1 month Rate of adverse events related or not related to intervention
Trial Locations
- Locations (1)
IMiD
🇵🇱Warsaw, Poland