Clinical Trials Logo

Clinical Trial Summary

Primary ciliary dyskinesia (PCD) is characterized by impaired airway clearance and mucus stagnation. This results in recurrent upper and lower respiratory tract infections often leading to chronic inflammation and, if not treated early and properly, to irreversible functional and structural changes of the respiratory tract. As there is no causal treatment of PCD yet, airway clearance techniques (ACT) provide fundamental care for these patients. Simeox is a new airway clearance device, recently developed by the French company PhysioAssist. This technology is based on pneumatic vibrations generated by the device itself. Vibrations are induced by rapidly alternating between atmospheric and negative pressure as the patient exhales, providing the most effective clearance of mucus from the lungs. Vibrations of different intensity and frequency are known to alter the rheological properties of mucus in the airways, whilst the negative pressure during exhalation helps to mobilise and drain the mucus to the central bronchi. Although there have not yet been any evidence based papers published clarifying the effect of Simeox specifically in patients with PCD, using up-to-date information, experience, and positive feedback from our patients, we assume that there could be a significant benefit for the effectiveness of ACT.


Clinical Trial Description

In this study the effectiveness of ACT will be evaluated based on the short-term effect(s) of respiratory physiotherapy with Simeox on changes in lung function and thoracic expansibility paediatric patients with PCD. An interventional randomised non-inferiority crossover trial will be conducted in Motol University Hospital; the project was developed by the multidisciplinary team (MDT) of the Division of Paediatric Pulmonology of the Department of Paediatrics, 2nd Faculty of Medicine, Charles University in Prague and Motol University Hospital; and the Department of Rehabilitation and Sports Medicine, 2nd Faculty of Medicine, Charles University in Prague and Motol University Hospital. Eligible patients will be randomly assigned into 2 arms - "Simeox-first group" and "Pari-O-PEP first" group. Randomisation will be done using computer generated code for each patient. The protocol will include 3 study visits - K0, K1 and K2 planned 3 months apart. After 6 months (second visit - K1), each patient will be switched to the other interventional group (crossed over). The first session (K0) includes an initial lung function assessment using spirometry, nitrogen-Multiple Breath Washout test (N2-MBW), Electrical Impedance Tomography (EIT), 6 Minute Walk Test (6 MWT), respiratory amplitudes (RA), and a theoretical introduction to therapy with the Simeox device. The second (K1) and third (K2) sessions will be interventional, including a respiratory physiotherapy session in between each measurement, excluding 6 MWT, which will be measured just once per session. According to randomisation criteria, participants will initially undergo either physiotherapist-administered 20-minute ACT session using the Simeox device or 30-minute therapy with PARI O-PEP. In accordance with the rules for crossover study design, each patient will undergo therapy with both ACT devices, ideally within six-month duration of the study. These interventions will take place in between each measurement (spirometry, MBW, EIT, RA) during the second (K1) and the third (K2) session. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04793724
Study type Interventional
Source University Hospital, Motol
Contact
Status Completed
Phase N/A
Start date July 15, 2019
Completion date February 28, 2023

See also
  Status Clinical Trial Phase
Recruiting NCT05889013 - Utility of PCD Diagnostics to Improve Clinical Care
Recruiting NCT01246258 - Otolith Function in Patients With Primary Ciliary Dyskinesia N/A
Completed NCT04858191 - Utilizing Hyperpolarized 129Xe Magnetic Resonance Imaging in Children With Primary Ciliary Dyskinesia
Completed NCT05712798 - Physiological Responses to Exercise Tests in Primary Ciliary Dyskinesia Compared With Healthy Individuals
Completed NCT03370029 - Respiratory Muscle Strength, Exercise Capacity and Physical Activity Levels in Children Primary Ciliary Dyskinesia
Completed NCT00368446 - Genetic Disorders of Mucociliary Clearance in Nontuberculous Mycobacterial Lung Disease
Recruiting NCT05374720 - Analysis of the Molecular Composition of Tubal Cilia in Patients With or Without Ectopic Pregnancy N/A
Completed NCT05816876 - Muscle Function, Exercise Capacity and Physical Activity Level in Primary Ciliary Dyskinesia and Kartagener Syndrome
Recruiting NCT04717115 - Genotype/Phenotype Correlation With Focus on Lung Function in Primary Ciliary Dyskinesia (PCD)
Recruiting NCT03279965 - MRI in Cystic Fibrosis and Primary Ciliary Dyskinesia N/A
Recruiting NCT03320382 - Multiple Breath Washout, a Clinimetric Dataset
Recruiting NCT04602481 - COVID-19 in People With Primary Ciliary Dyskinesia
Not yet recruiting NCT02704455 - Registry Study on Primary Ciliary Dyskinesia in Chinese Children N/A
Completed NCT00323167 - Rare Genetic Disorders of the Breathing Airways
Recruiting NCT05932316 - Evaluating Bronchodilator Response in Patients With Bronchiectasis N/A
Completed NCT03832491 - Effect of Game Based Approach on Oxygenation, Functional Capacity and Quality of Life in Primary Ciliary Dyskinesia N/A
Recruiting NCT05951478 - DCP (RaDiCo Cohort) (RaDiCo-DCP)
Completed NCT06028607 - Feasibility of Consumption of Nutritional Supplementation in Primary Ciliary Dyskinesia N/A
Recruiting NCT05685186 - A Longitudinal, Observational Study of Primary Ciliary Dyskinesia in Adults
Recruiting NCT05161858 - Longitudinal Characterization of Respiratory Tract Exacerbations and Treatment Responses in Primary Ciliary Dyskinesia