Effects of SIMEOX on Airway Clearance in Cystic Fibrosis

Not Applicable

Completed

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

• Registration Number: NCT04187924
• Lead Sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-11-27
• Study First Submitted: 2019-11-27
• Study First Submitted QC: 2019-12-03
• Study First Posted: 2019-12-05
• Primary Completion: 2021-11-30
• Study Completion: 2021-11-30
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-06
• Last Update Posted: 2024-05-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
SIMEOX + Autogenic drainage	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.
Autogenic drainage	Autogenic drainage	Patients will have to perform a 30-min session of autogenic drainage. Sputum will be collected during the session.

Primary Outcome Measures

Name	Time	Method
Amount of sputum secretion	30-min	Total wet weight and dry weight of sputum collected in the 24-h following each intervention will be quantified.
Subjective feeling of ease to expectorate	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.
Mucus viscoelasticity	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.

Trial Locations

Locations (1)

Cliniques universitaires Saint-Luc; 🇧🇪 Brussels, Brussels Capital, Belgium