MUCOSIMSimeox® vs. Autogenous Drainage for Pulmonary Function Improvement in Adult Cystic Fibrosis Patients
This study aims to compare the effectiveness of Simeox® and Autogenous Drainage in improving pulmonary function, specifically focusing on low frequency resistance R5, in adult patients diagnosed with Cystic Fibrosis.
SIMEOX
+ Autogenic drainage
Cystic Fibrosis+5
+ Digestive System Diseases
+ Infant, Newborn, Diseases
Treatment Study
Summary
Study start date: September 30, 2019
Actual date on which the first participant was enrolled.This study aims to compare the short-term impacts of two different airway clearing techniques on the lung function of adult patients with stable cystic fibrosis. The techniques being compared are the use of a medical device called Simeox and a manual technique known as Autogenic Drainage. Cystic fibrosis is a condition that affects the lungs and digestive system, causing the body to produce thick and sticky mucus. This research is important as it could help improve the care and treatment options for individuals living with this condition, potentially enhancing their quality of life.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.31 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Inclusion Criteria: * Diagnosis of cystic fibrosis confirmed * Age ≥18 years * 30% \<FEV1 \<70% predicted * Presence of bronchial congestion reported by the patient or the investigator Exclusion Criteria: * Uncontrolled asthma * Pneumothorax \<6 weeks * Recent severe hemoptysis \<6 weeks * Patient registered on the transplant list * Exacerbation within 4 weeks (3 months if hospitalization) before screening * Cardiovascular disorders, electrocardiogram (ECG) parameters or clinically significant respiratory (non-cystic fibrosis) conditions * Patients unable to perform measurements of ROF, spirometry, plethysmography. * Any contraindication to manual or instrumental physiotherapy. * Pregnancy, breastfeeding. * Patient under tutorship or curatorship * No affiliation to the French social security * Patient using Simeox at home * Patient under Trikafta for less than 6 weeks. * Patient using Simeox more than twice a week during physiotherapy sessions, not wanting a washout period of 7 days before inclusion
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.2 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
Active ComparatorGroup II
ExperimentalStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 8 locations
Hôpital la Bocage CHRU de Dijon
Dijon, FranceCHRU Lille - Hopital Calmette
Lille, FranceGH Sud - Hospices Civils de Lyon
Lyon, France