Effects of SIMEOX on Airway Clearance in Cystic Fibrosis

NCT04187924 | Completed

• 1 other identifier: SIMEOX-003
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Cystic Fibrosis

Outcome Measures

Primary Outcomes (3)

• 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

• 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.

  30-min

• 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

Study Arms (2)

Autogenic drainage

ACTIVE COMPARATOR

Patients will have to perform a 30-min session of autogenic drainage. Sputum will be collected during the session.

Other: Autogenic drainage

SIMEOX + Autogenic drainage

ACTIVE COMPARATOR

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

Interventions

Autogenic drainage OTHER

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.

Autogenic drainage

SIMEOX + Autogenic drainage DEVICE

SIMEOX is a device generating a succession of gentle depression at the mouth during the expiratory phase associated with autogenic drainage.

SIMEOX + Autogenic drainage

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Regular use of SIMEOX,
• Difficulties in understanding instructions,
• Severe cardiac comorbidity.

Sponsors & Collaborators

• Cliniques universitaires Saint-Luc- Université Catholique de Louvain: lead

Study Sites (1)

Cliniques universitaires Saint-Luc

Brussels, Brussels Capital, 1200, Belgium

Location

MeSH Terms

Conditions

Cystic Fibrosis

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Lung Diseases; Respiratory Tract Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 27, 2019
• First Posted: December 5, 2019
• Study Start: November 27, 2019
• Primary Completion: November 30, 2021
• Study Completion: November 30, 2021
• Last Updated: May 8, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)