Last updated: July 20, 2022
Sponsor: Association Nationale pour les Traitements A Domicile, les Innovations et la Recherche
Overall Status: Active - Recruiting
Phase
N/A
Condition
Cystic Fibrosis
Lung Disease
Scar Tissue
Treatment
N/AClinical Study ID
NCT04010253
2019-A00622-55
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
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
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 significantrespiratory (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 wantinga washout period of 7 days before inclusion
Study Design
Total Participants: 42
Study Start date:
September 30, 2019
Estimated Completion Date:
December 31, 2023
Connect with a study center
CH Amiens
Amiens,
FranceActive - Recruiting
Hôpital la Bocage CHRU de Dijon
Dijon,
FranceActive - Recruiting
CHRU Lille - Hopital Calmette
Lille,
FranceActive - Recruiting
GH Sud - Hospices Civils de Lyon
Lyon,
FranceSuspended
CH Nice
Nice,
FranceActive - Recruiting
Soins de Suite Nutritionnels et Respiratoires -Fondation IDLYS
Roscoff,
FranceActive - Recruiting
CHU de Rouen
Rouen,
FranceActive - Recruiting
Hopital Larrey
Toulouse,
FranceActive - Recruiting
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