HealthyNCT04150601
Effects of SIMEOX on Flow and Volume in Healthy Subjects and Patients With COPD
A study testing SIMEOX, PEP and Spontaneous Exhalation in people with Healthy and Pulmonary Disease, Chronic Obstructive, run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain at 1 site in Belgium.
Trial summary
This study will investigate the effects on the SIMEOX technology on flow and volume generated in healthy subjects and patients with COPD Read more about this study
- Who is it for?
- Ages 45 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy, Pulmonary Disease, Chronic Obstructive
- What is being tested?
- SIMEOX, PEP and Spontaneous Exhalation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Aug 2019to 16 Nov 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 45 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy subjects: able to understand the instructions, no acute or chronic respiratory upper or lower airway disease, normal lung function.
- Patients with COPD: able to understand the instructions; FEV1<80% predicted value, naive to the SIMEOX device.
Who cannot join
- Healthy subjects: obesity (BMI > 30kg/m²); active or former smoker; severe scoliosis; cardiovascular or neuromuscular disease.
- Patients with COPD: obesity (BMI > 30kg/m²); severe scoliosis; cardiovascular or neuromuscular disease.
Trial locations and contacts
1 site in 1 country.
Belgium1 site
Cliniques universitaires Saint-Luc
Brussels, Brussels Capital, 1200
About this study
Official title: Evaluation of SIMEOX Technology on Volumes and Flows Generated in Healthy Subjects and Patients With COPD
This study will investigate the effects on the SIMEOX technology on flow and volume generated in healthy subjects and patients with COPD
Read the detailed description
This is a crossover study assessing the immediate physiological effects of SIMEOX and a PEP device on the exhalation phase in healthy subjects and patients with COPD.
Participants will perform (1) a slow vital capacity, (2) a maximal expiration from total lung capacity to residual volume with SIMEOX, (3) a maximal expiration from total lung capacity to residual volume with a PEP device.
- Conditions
- Healthy, Pulmonary Disease, Chronic Obstructive
- Being tested
- SIMEOX, PEP, Spontaneous Exhalation
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
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.
PEPDevice
A PEP device (Pari-PEP) will be used to provoke a positive expiratory pressure while exhaling, thereby stabilizing the airways during expiration.
Spontaneous ExhalationOther
A slow vital capacity maneuver will be performed according to the guidelines, from total lung capacity to residual volume
| Study group | Role | What they receive |
|---|---|---|
| Spontaneous slow vital capacity | Active comparator | Participants will have to perform a slow vital capacity according to the guidelines, from total lung capacity to residual volume Receives: Other: Spontaneous Exhalation |
| SIMEOX | Active comparator | Participants will have to perform a passive exhalation using the SIMEOX, starting from total lung capacity and going until achieving residual volume Receives: Device: SIMEOX |
| PEP | Active comparator | Participants will have to perform an active exhalation using a PEP device, starting from total lung capacity and going until achieving residual volume Receives: Device: PEP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in expiratory volume
Expiratory volume change between the 3 conditions (spontaneous expiration, SIMEOX and PEP).
Measured: 5 minutes
Change in expiratory flow
Expiratory flow change between the 3 conditions (spontaneous expiration, SIMEOX and PEP).
Measured: 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2019
- Study start1 Aug 2019
- Primary completion16 Nov 2021
- Study completion16 Nov 2021
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
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, William Poncin, PT, PhD, Cliniques universitaires Saint-Luc- Université Catholique de Louvain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04150601
- Sponsor's protocol ID
- SIMEOX-002
- Status last verified
- Nov 2023
- First submitted
- 31 Oct 2019
- Last updated
- 21 Nov 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of SIMEOX Technology on Volumes and Flows Generated in Healthy Subjects and Patients With COPD
- ClinicalTrials.gov ID
- NCT04150601
- Acronym / sponsor ID
- SIMEOX-002
- Conditions
- Healthy, Pulmonary Disease, Chronic Obstructive
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Cliniques universitaires Saint-Luc- Université Catholique de LouvainUniversity, hospital or other
- Study start
- 1 Aug 2019 (actual)
- Primary completion
- 16 Nov 2021 (actual)
- Study completion
- 16 Nov 2021 (actual)
- First posted
- 5 Nov 2019 (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 on the SIMEOX technology on flow and volume generated in healthy subjects and patients with COPD
Detailed description
This is a crossover study assessing the immediate physiological effects of SIMEOX and a PEP device on the exhalation phase in healthy subjects and patients with COPD.
Participants will perform (1) a slow vital capacity, (2) a maximal expiration from total lung capacity to residual volume with SIMEOX, (3) a maximal expiration from total lung capacity to residual volume with a PEP device.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Spontaneous slow vital capacity | Active comparator | Other: Spontaneous ExhalationParticipants will have to perform a slow vital capacity according to the guidelines, from total lung capacity to residual volume |
| SIMEOX | Active comparator | Device: SIMEOXParticipants will have to perform a passive exhalation using the SIMEOX, starting from total lung capacity and going until achieving residual volume |
| PEP | Active comparator | Device: PEPParticipants will have to perform an active exhalation using a PEP device, starting from total lung capacity and going until achieving residual volume |
Who may qualify
- Ages
- 45 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Healthy subjects: able to understand the instructions, no acute or chronic respiratory upper or lower airway disease, normal lung function.
- Patients with COPD: able to understand the instructions; FEV1<80% predicted value, naive to the SIMEOX device.
Key exclusion criteria (2 listed)
- Healthy subjects: obesity (BMI > 30kg/m²); active or former smoker; severe scoliosis; cardiovascular or neuromuscular disease.
- Patients with COPD: obesity (BMI > 30kg/m²); severe scoliosis; cardiovascular or 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 |
| PEPA PEP device (Pari-PEP) will be used to provoke a positive expiratory pressure while exhaling, thereby stabilizing the airways during expiration. | Device | PEP |
| Spontaneous ExhalationA slow vital capacity maneuver will be performed according to the guidelines, from total lung capacity to residual volume | Other | Spontaneous slow vital capacity |
Primary outcome
Change in expiratory volume
Time frame: 5 minutes
Expiratory volume change between the 3 conditions (spontaneous expiration, SIMEOX and PEP).
Change in expiratory flow
Time frame: 5 minutes
Expiratory flow change between the 3 conditions (spontaneous expiration, SIMEOX and PEP).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2023.
- Individual participant dataSharing planned: No
Related trials for Healthy
Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
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.
The record lists no contact. Use the official record to reach the sponsor.
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, PEP and Spontaneous Exhalation in people with Healthy and Pulmonary Disease, Chronic Obstructive, 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 2 inclusion and 2 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: finished, as of the sponsor's last update on 21 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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: 5 minutes). 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 21 Nov 2023.