Impact of Bronchial Drainage Technique by the Medical Device Simeox® on Respiratory Function and Symptoms in Adult Patients With Cystic Fibrosis

Not Applicable

• Conditions: Cystic Fibrosis
• Interventions: Other: Autogenic drainage; Device: SIMEOX

• Registration Number: NCT04010253
• Lead Sponsor: Association Nationale pour les Traitements A Domicile, les Innovations et la Recherche

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 function of adult patients with stable cystic fibrosis. To analyse these effects, the investigators used forced oscillation technique measured by TremoFlo™ C-100 Airwave Oscillometry System™ (THORASYS Thoracic Medical Systems Inc. Montreal, Quebec, Canada) with an evaluation of the perceived clinical benefits.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-07-03
• Study First Submitted QC: 2019-07-05
• Study First Posted: 2019-07-08
• Study Start: 2019-09-30
• Status Verified: 2022-07
• Last Update Submitted: 2022-07-20
• Last Update Posted: 2022-07-21
• Primary Completion: 2023-12-30
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 42

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
SIMEOX	Autogenic drainage	-
Autogenic Drainage	SIMEOX	-

Primary Outcome Measures

Name	Time	Method
Low frequency resistance R5	1 month	Comparison of variations V4 and V8 sessions (pre and post airway clearance session)

Secondary Outcome Measures

Name	Time	Method
Evaluation of the distal and / or proximal decluttering by the two techniques, according to the improvement profile of the forced oscillations	1 month
Evaluation of correlations between clinical benefit and changes in functional respiratory investigations (forced oscillations, spirometry, plethysmography)	1 month
Comparison of the impact of Simeox® bronchial drainage compared to autogenous drainage on respiratory symptoms: dyspnea, congestion and fatigue	1 month
Evaluation of the impact of Simeox® bronchial drainage vs autogenous drainage by spirometry and plethysmography (distension and resistance)	1 month

Trial Locations

Locations (8)

CH Amiens; 🇫🇷 Amiens, France

Hôpital la Bocage CHRU de Dijon; 🇫🇷 Dijon, France

CHRU Lille - Hopital Calmette; 🇫🇷 Lille, France

CH Nice; 🇫🇷 Nice, France

GH Sud - Hospices Civils de Lyon; 🇫🇷 Lyon, France

Hopital Larrey; 🇫🇷 Toulouse, France

Soins de Suite Nutritionnels et Respiratoires -Fondation IDLYS; 🇫🇷 Roscoff, France

CHU de Rouen; 🇫🇷 Rouen, France