Effects of SIMEOX on Airway Clearance in Cystic Fibrosis

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Status: Completed

Conditions: Cystic Fibrosis

Treatments: Device: SIMEOX + Autogenic drainage; Other: Autogenic drainage

Study type: Interventional

Funder types: Other

Identifiers

NCT04187924

SIMEOX-003

Details and patient eligibility

About

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.

Enrollment: 20 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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20 participants in 2 patient groups

Autogenic drainage

Active Comparator group

Description:

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

Treatment:

Other: Autogenic drainage

SIMEOX + Autogenic drainage

Active Comparator group

Description:

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

Treatment:

Device: SIMEOX + Autogenic drainage