Effects of SIMEOX on Airway Clearance in Cystic Fibrosis
Primary Purpose
Cystic Fibrosis
Status
Unknown status
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Autogenic drainage
SIMEOX + Autogenic drainage
Sponsored by
About this trial
This is an interventional treatment trial for Cystic Fibrosis
Eligibility 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.
Sites / Locations
- Cliniques universitaires Saint-LucRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Autogenic drainage
SIMEOX + Autogenic drainage
Arm Description
Patients will have to perform a 30-min session of autogenic drainage. Sputum will be collected during the session.
Patients will have to perform a 30-min session of autogenic drainage with the SIMEOX device. Sputum will be collected during the session.
Outcomes
Primary Outcome Measures
Amount of sputum secretion
Total wet weight and dry weight of sputum collected in the 24-h following each intervention will be quantified.
Mucus viscoelasticity
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.
Subjective feeling of ease to expectorate
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT04187924
First Posted
November 27, 2019
Last Updated
March 15, 2021
Sponsor
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
1. Study Identification
Unique Protocol Identification Number
NCT04187924
Brief Title
Effects of SIMEOX on Airway Clearance in Cystic Fibrosis
Official Title
Effects of the Addition of the SIMEOX Device on Autogenic Drainage in Patients With Cystic Fibrosis
Study Type
Interventional
2. Study Status
Record Verification Date
March 2021
Overall Recruitment Status
Unknown status
Study Start Date
November 27, 2019 (Actual)
Primary Completion Date
December 2022 (Anticipated)
Study Completion Date
December 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cystic Fibrosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Autogenic drainage
Arm Type
Active Comparator
Arm Description
Patients will have to perform a 30-min session of autogenic drainage. Sputum will be collected during the session.
Arm Title
SIMEOX + Autogenic drainage
Arm Type
Active Comparator
Arm Description
Patients will have to perform a 30-min session of autogenic drainage with the SIMEOX device. Sputum will be collected during the session.
Intervention Type
Other
Intervention Name(s)
Autogenic drainage
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
SIMEOX + Autogenic drainage
Intervention Description
SIMEOX is a device generating a succession of gentle depression at the mouth during the expiratory phase associated with autogenic drainage.
Primary Outcome Measure Information:
Title
Amount of sputum secretion
Description
Total wet weight and dry weight of sputum collected in the 24-h following each intervention will be quantified.
Time Frame
30-min
Title
Mucus viscoelasticity
Description
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.
Time Frame
30-min
Title
Subjective feeling of ease to expectorate
Description
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.
Time Frame
3-min
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
William Poncin, PT, PhD
Phone
+3227642316
Email
william.poncin@uclouvain.be
First Name & Middle Initial & Last Name or Official Title & Degree
Juliana RFF de Macedo, PT, MSc
Email
juliana.ribeiro@uclouvain.be
Facility Information:
Facility Name
Cliniques universitaires Saint-Luc
City
Brussels
State/Province
Brussels Capital
ZIP/Postal Code
1200
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
William Poncin
Phone
+320470592032
Ext
+320470592032
Email
william.poncin@uclouvain.be
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Effects of SIMEOX on Airway Clearance in Cystic Fibrosis
We'll reach out to this number within 24 hrs