NCT03655860

Brief Summary

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

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Sep 2018

Longer than P75 for not_applicable healthy

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 28, 2018

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 31, 2018

Completed
15 days until next milestone

Study Start

First participant enrolled

September 15, 2018

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2021

Completed
Last Updated

November 28, 2023

Status Verified

November 1, 2023

Enrollment Period

3.3 years

First QC Date

August 28, 2018

Last Update Submit

November 22, 2023

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

  • 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

Study Arms (1)

SIMEOX

EXPERIMENTAL

Use of the device SIMEOX to exhale

Device: SIMEOX

Interventions

SIMEOXDEVICE

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

SIMEOX

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Able to understand the instructions

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

William Poncin

Brussels, 1200, Belgium

Location

Study Officials

  • Grégory Reychler, PhD

    Cliniques universitaires Saint-Luc- Université Catholique de Louvain

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 28, 2018

First Posted

August 31, 2018

Study Start

September 15, 2018

Primary Completion

December 30, 2021

Study Completion

December 30, 2021

Last Updated

November 28, 2023

Record last verified: 2023-11

Locations

BE(1)