Effects of SIMEOX on Airway Clearance in Cystic Fibrosis

Cystic Fibrosis Clinical Trial

Official title:

Effects of the Addition of the SIMEOX Device on Autogenic Drainage in Patients With Cystic Fibrosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04187924
• Other study ID #: SIMEOX-003
• Status: Completed
• Phase: N/A
• Start date: November 27, 2019
• Est. completion date: November 30, 2021

Study information

• Verified date: May 2024
• Source: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: November 30, 2021
• Est. primary completion date: November 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cystic Fibrosis
• Fibrosis

Intervention

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.

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.

Locations

Country	Name	City	State
Belgium	Cliniques universitaires Saint-Luc	Brussels	Brussels Capital

Sponsors (1)

Lead Sponsor	Collaborator
Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Amount of sputum secretion	Total wet weight and dry weight of sputum collected in the 24-h following each intervention will be quantified.	30-min
Primary	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 (tand) of the secretions collected before and after each intervention.	30-min
Primary	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.	3-min