Status:
UNKNOWN
Impact of Bronchial Drainage Technique by the Medical Device Simeox® on Respiratory Function and Symptoms in Adult Patients With Cystic Fibrosis
Lead Sponsor:
Association Nationale pour les Traitements A Domicile, les Innovations et la Recherche
Conditions:
Cystic Fibrosis
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The main objective of the study is to evaluate the short-term effects of the airway clearance technique by the medical device Simeox (Physio Assist, France) versus Autogenic Drainage, on the pulmonary...
Eligibility Criteria
Inclusion
- Diagnosis of cystic fibrosis confirmed
- Age ≥18 years
- 30% \<FEV1 \<70% predicted
- Presence of bronchial congestion reported by the patient or the investigator
Exclusion
- 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
Key Trial Info
Start Date :
September 30 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2023
Estimated Enrollment :
42 Patients enrolled
Trial Details
Trial ID
NCT04010253
Start Date
September 30 2019
End Date
December 31 2023
Last Update
July 21 2022
Active Locations (8)
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1
CH Amiens
Amiens, France
2
Hôpital la Bocage CHRU de Dijon
Dijon, France
3
CHRU Lille - Hopital Calmette
Lille, France
4
GH Sud - Hospices Civils de Lyon
Lyon, France