HealthyNCT03655860
Effects of SIMEOX on Flow and Volume
A study testing SIMEOX in people with Healthy, run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain at 1 site in Belgium.
Trial summary
This study will investigate the effects of the SIMEOX (an airway clearance device) on flow and volume generated in healthy subjects Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- SIMEOX
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteBelgium
- Study dates
- 15 Sep 2018to 30 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Able to understand the instructions
Who cannot join
- Obesity (BMI > 30kg/m²)
- Active smoker
- Severe scoliosis
- Cardiovascular ou neuromuscular disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of SIMEOX on Flow and Volume Elicited in Healthy Subjects
This study will investigate the effects of the SIMEOX (an airway clearance device) on flow and volume generated in healthy subjects
Read the 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.
- Conditions
- Healthy
- Being tested
- SIMEOX
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SIMEOXDevice
SIMEOX is a device generating a succession of gentle depression at the mouth.
| Study group | Role | What they receive |
|---|---|---|
| SIMEOX | Experimental | Use of the device SIMEOX to exhale Receives: Device: SIMEOX |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in expiratory volume
Expiratory volume before and during the use of the SIMEOX will be compared
Measured: 5min
Change in expiratory volume flow rate
Expiratory flow rate before and during the use of the SIMEOX will be compared
Measured: 5min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2018
- Study start15 Sep 2018
- Primary completion30 Dec 2021
- Study completion30 Dec 2021
Why it stopped: Never started, was replaced by NCT04150601
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Cliniques universitaires Saint-Luc- Université Catholique de LouvainThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Grégory Reychler, PhD, Principal investigator, Cliniques universitaires Saint-Luc- Université Catholique de Louvain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03655860
- Sponsor's protocol ID
- SIMEOX-01
- Other IDs
- 2018/08AOU/312
- Status last verified
- Nov 2023
- First submitted
- 28 Aug 2018
- Last updated
- 28 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of SIMEOX on Flow and Volume Elicited in Healthy Subjects
- ClinicalTrials.gov ID
- NCT03655860
- Acronym / sponsor ID
- SIMEOX-01
- Conditions
- Healthy
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Never started, was replaced by NCT04150601
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Cliniques universitaires Saint-Luc- Université Catholique de LouvainUniversity, hospital or other
- Study start
- 15 Sep 2018 (actual)
- Primary completion
- 30 Dec 2021 (actual)
- Study completion
- 30 Dec 2021 (actual)
- First posted
- 31 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SIMEOX | Experimental | Device: SIMEOXUse of the device SIMEOX to exhale |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Able to understand the instructions
Key exclusion criteria (4 listed)
- Obesity (BMI > 30kg/m²)
- Active smoker
- Severe scoliosis
- Cardiovascular ou neuromuscular disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SIMEOXSIMEOX is a device generating a succession of gentle depression at the mouth. | Device | SIMEOX |
Primary outcome
Change in expiratory volume
Time frame: 5min
Expiratory volume before and during the use of the SIMEOX will be compared
Change in expiratory volume flow rate
Time frame: 5min
Expiratory flow rate before and during the use of the SIMEOX will be compared
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Grégory Reychler, PhD principal investigator
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SIMEOX in people with Healthy, run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 28 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in expiratory volume (time frame: 5min). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Nov 2023.