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NCT Number: NCT04187924

Effects of SIMEOX on Airway Clearance in Cystic Fibrosis

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.

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Key information

Conditions

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

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cliniques universitaires Saint-Luc

Brussels, Brussels Capital, 1200, Belgium

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

Primary outcomes

  1. Amount of sputum secretion

    Time frame: 30-min

    Total wet weight and dry weight of sputum collected in the 24-h following each intervention will be quantified.

  2. Mucus viscoelasticity

    Time frame: 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.

  3. Subjective feeling of ease to expectorate

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Dec 5, 2019
Registry last updated
May 8, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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