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Effects of SIMEOX on Airway Clearance in Cystic Fibrosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04187924
Recruitment Status : Unknown
Verified March 2021 by Poncin, Cliniques universitaires Saint-Luc- Université Catholique de Louvain.
Recruitment status was:  Recruiting
First Posted : December 5, 2019
Last Update Posted : March 16, 2021
Sponsor:
Information provided by (Responsible Party):
Poncin, Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Study Description
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Brief Summary:

This study will investigate the contribution of SIMEOX technology on the effectiveness of bronchial drainage.

This is a crossover study to evaluate the contribution of SIMEOX on the effectiveness of bronchial drainage (verified by the amount of sputum secretions, the rheology of sputum secretions and the subjective sensation of ease of sputum) in patients with cystic fibrosis.

Patients will perform, in randomized order (1) a 30-min session of autogenic drainage, (2) a 30-min session of autogenic drainage with the SIMEOX device. Sputum will be collected during and after the session. The two sessions will be performed with minimum washout time of 24 hours.


Condition or disease Intervention/treatment Phase
Cystic Fibrosis Other: Autogenic drainage Device: SIMEOX + Autogenic drainage Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effects of the Addition of the SIMEOX Device on Autogenic Drainage in Patients With Cystic Fibrosis
Actual Study Start Date : November 27, 2019
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cystic Fibrosis

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Autogenic drainage
Patients will have to perform a 30-min session of autogenic drainage. Sputum will be collected during the session.
 Other: Autogenic drainage
Autogenic drainage is an airway clearance technique characterised by breathing control using expiratory airflow to mobilise secretions from smaller to larger airways. The secretions will be collected during the physiotherapy session and during the 24 hours following the session.
Active Comparator: SIMEOX + Autogenic drainage
Patients will have to perform a 30-min session of autogenic drainage with the SIMEOX device. Sputum will be collected during the session.
 Device: SIMEOX + Autogenic drainage
SIMEOX is a device generating a succession of gentle depression at the mouth during the expiratory phase associated with autogenic drainage.


Outcome Measures
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Primary Outcome Measures :
  1. Amount of sputum secretion [ Time Frame: 30-min ]
    Total wet weight and dry weight of sputum collected in the 24-h following each intervention will be quantified.

  2. Mucus viscoelasticity [ Time Frame: 30-min ]
    Change in rheological properties of the sputum before and after each intervention will be analyzed using a rheometer. We will use the Rheomuco (Rheonova) reometer to obtain the differences in elasticity (G'), viscosity (G')' and elastic modulus ratio (tanδ) of the secretions collected before and after each intervention.

  3. Subjective feeling of ease to expectorate [ Time Frame: 3-min ]

    A Visual Analogue Scale (VAS) will be used to measure subjective feeling of ease of expectoration during each intervention.

    The visual analogue scale (VAS) is a semi-objective rating system that will be used to quantify the subjective feeling of ease to expectorate. The VAS is represented by a horizontal line marked 0 to 10, where "0" indicates "very easy to expectorate" and "10" indicates "not easy to expectorate at all". The lower the score, the easier it is to expectorate.



Eligibility Criteria
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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adults with cystic fibrosis
  • Chronic bronchorrhea, able to expectorate by themselves
  • Hospitalized

Exclusion Criteria:

  • Regular use of SIMEOX,
  • Difficulties in understanding instructions,
  • Severe cardiac comorbidity.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04187924


Contacts
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Contact: William Poncin, PT, PhD +3227642316 william.poncin@uclouvain.be
Contact: Juliana RFF de Macedo, PT, MSc juliana.ribeiro@uclouvain.be

Locations
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Belgium
Cliniques universitaires Saint-Luc Recruiting
Brussels, Brussels Capital, Belgium, 1200
Contact: William Poncin    +320470592032 ext +320470592032    william.poncin@uclouvain.be   
Sponsors and Collaborators
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
More Information
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Responsible Party: Poncin, Principal Investigator, Cliniques universitaires Saint-Luc- Université Catholique de Louvain
ClinicalTrials.gov Identifier: NCT04187924    
Other Study ID Numbers: SIMEOX-003
First Posted: December 5, 2019    Key Record Dates
Last Update Posted: March 16, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Cystic Fibrosis
Fibrosis
Pathologic Processes
Pancreatic Diseases
Digestive System Diseases
 Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases