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NCT03655860 Clinical Trial

Effects of SIMEOX on Flow and Volume

Healthy Clinical Trial

Official title:
Evaluation of SIMEOX on Flow and Volume Elicited in Healthy Subjects

Clinical Trial Details — Status: Withdrawn

Administrative data
NCT number NCT03655860
Other study ID # SIMEOX-01
Secondary ID 2018/08AOU/312
Status Withdrawn
Phase N/A
First received
Last updated
Start date September 15, 2018
Est. completion date December 30, 2021

Study information
Verified date November 2023
Source Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study will investigate the effects of the SIMEOX (an airway clearance device) on flow and volume generated in healthy subjects

Description:

This is a pilot study assessing the effect of the SIMEOX device on flow and volume generated in healthy subjects. Assessment of flow and volume will be performed before and during the application of the SIMEOX. Vital capacity and expiratory flow will be assessed.

Recruitment information / eligibility
Status Withdrawn
Enrollment 0
Est. completion date December 30, 2021
Est. primary completion date December 30, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria: - Able to understand the instructions Exclusion Criteria: - Obesity (BMI > 30kg/m²) - Active smoker - Severe scoliosis - Cardiovascular ou neuromuscular disease

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• SIMEOX
SIMEOX is a device generating a succession of gentle depression at the mouth.

Locations
Country Name City State
Belgium William Poncin Brussels

Sponsors (1)
Lead Sponsor Collaborator
Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Country where clinical trial is conducted

Belgium, 

Outcome
Type Measure Description Time frame Safety issue
Primary Change in expiratory volume Expiratory volume before and during the use of the SIMEOX will be compared 5min
Primary Change in expiratory volume flow rate Expiratory flow rate before and during the use of the SIMEOX will be compared 5min
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