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

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/A

Clinical Study ID

NCT04010253
2019-A00622-55
  • Ages > 18
  • All Genders

Study 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.

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,
    France

    Active - Recruiting

  • Hôpital la Bocage CHRU de Dijon

    Dijon,
    France

    Active - Recruiting

  • CHRU Lille - Hopital Calmette

    Lille,
    France

    Active - Recruiting

  • GH Sud - Hospices Civils de Lyon

    Lyon,
    France

    Suspended

  • CH Nice

    Nice,
    France

    Active - Recruiting

  • Soins de Suite Nutritionnels et Respiratoires -Fondation IDLYS

    Roscoff,
    France

    Active - Recruiting

  • CHU de Rouen

    Rouen,
    France

    Active - Recruiting

  • Hopital Larrey

    Toulouse,
    France

    Active - Recruiting

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