Effects of SIMEOX on Flow and Volume | NCT03655860

Studies
Effects of SIMEOX on Flow and Volume

NCT03655860

Sponsor

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Status

Withdrawn

Last Update Posted

Nov 28, 2023Actual

Enrollment

0Actual

Phase

Not Applicable

Conditions

Healthy

Interventions

SIMEOX

Countries

Belgium

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
2018/08AOU/312	Other Identifier	CEHF

Status Module

Record Verification Date

Nov 2023

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Never started, was replaced by NCT04150601

Expanded Access Info

Start Date

Sep 15, 2018Actual

Primary Completion Date

Dec 30, 2021Actual

Completion Date

Dec 30, 2021Actual

First Submitted Date

Aug 28, 2018

First Submission Date that Met QC Criteria

Aug 30, 2018

First Posted Date

Aug 31, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 22, 2023

Last Update Posted Date

Nov 28, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
SIMEOX	Experimental	Use of the device SIMEOX to exhale	Device: SIMEOX

Interventions

Name	Type	Description	Arm Group Labels	Other Names
SIMEOX	Device	SIMEOX is a device generating a succession of gentle depression at the mouth.	SIMEOX

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change in expiratory volume	Expiratory volume before and during the use of the SIMEOX will be compared	5min
Change in expiratory volume flow rate	Expiratory flow rate before and during the use of the SIMEOX will be compared	5min

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Able to understand the instructions

Exclusion Criteria:

Obesity (BMI > 30kg/m²)
Active smoker
Severe scoliosis
Cardiovascular ou neuromuscular disease

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Grégory Reychler, PhD	Cliniques universitaires Saint-Luc- Université Catholique de Louvain	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
William Poncin		Brussels		1200	Belgium