Effects of SIMEOX on Flow and Volume
Sponsor
Cliniques universitaires Saint-Luc- Université Catholique de Louvain (Other)
Overall Status
Recruiting
CT.gov ID
NCT03655860
Collaborator
(none)
30
1
1
39.5
0.8
Study Details
Study Description
Brief Summary
This study will investigate the effects of the SIMEOX (an airway clearance device) on flow and volume generated in healthy subjects
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed 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.
Study Design
Study Type:
Interventional
Anticipated Enrollment
:
30 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Evaluation of SIMEOX on Flow and Volume Elicited in Healthy Subjects
Actual Study Start Date
:
Sep 15, 2018
Anticipated Primary Completion Date
:
Dec 30, 2021
Anticipated Study Completion Date
:
Dec 30, 2021
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: SIMEOX
|
Device: SIMEOX
SIMEOX is a device generating a succession of gentle depression at the mouth.
|
Outcome Measures
Primary Outcome Measures
- Change in expiratory volume [5min]
Expiratory volume before and during the use of the SIMEOX will be compared
- Change in expiratory volume flow rate [5min]
Expiratory flow rate before and during the use of the SIMEOX will be compared
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
- Able to understand the instructions
Exclusion Criteria:
-
Obesity (BMI > 30kg/m²)
-
Active smoker
-
Severe scoliosis
-
Cardiovascular ou neuromuscular disease
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | William Poncin | Brussels | 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:
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
ClinicalTrials.gov Identifier:
NCT03655860
Other Study ID Numbers:
- SIMEOX-01
- 2018/08AOU/312
First Posted:
Aug 31, 2018
Last Update Posted:
Nov 3, 2020
Last Verified:
Nov 1, 2020
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No