Effects of SIMEOX on Airway Clearance in Cystic Fibrosis

Sponsor

Cliniques universitaires Saint-Luc- Université Catholique de Louvain (Other)

Overall Status

Recruiting

CT.gov ID

NCT04187924

Collaborator

(none)

Enrollment

Location

Arms

36.1

Anticipated Duration (Months)

0.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cystic Fibrosis	Other: Autogenic drainage Device: SIMEOX + Autogenic drainage	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

20 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Nov 27, 2019

Anticipated Primary Completion Date :

Dec 1, 2022

Anticipated Study Completion Date :

Dec 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Autogenic drainage Patients will have to perform a 30-min session of autogenic drainage. Sputum will be collected during the session.	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.
Active Comparator: 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.	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.

Arm

Intervention/Treatment

Active Comparator: Autogenic drainage

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

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.

Active Comparator: 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.

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.

Outcome Measures

Primary Outcome Measures

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.
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.
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 90 Years

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Cliniques universitaires Saint-Luc	Brussels	Brussels Capital	Belgium	1200

Sponsors and Collaborators

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Poncin, Principal Investigator, Cliniques universitaires Saint-Luc- Université Catholique de Louvain

ClinicalTrials.gov Identifier:

NCT04187924

Other Study ID Numbers:

SIMEOX-003

First Posted:

Dec 5, 2019

Last Update Posted:

Mar 16, 2021

Last Verified:

Mar 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Cystic Fibrosis

Fibrosis

Study Results

No Results Posted as of Mar 16, 2021