Cystic FibrosisNCT04187924
Effects of SIMEOX on Airway Clearance in Cystic Fibrosis
A study testing Autogenic drainage and SIMEOX + Autogenic drainage in people with Cystic Fibrosis, run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain at 1 site in Belgium.
Trial summary
This study will investigate the contribution of SIMEOX technology on the effectiveness of bronchial drainage. This is a crossover study to evaluate the contribution of SIMEOX on the effectiveness of bronchial drainage (verified by the amount of sputum secretions, the rheology of sputum secretions and the subjective… Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Cystic Fibrosis
- What is being tested?
- Autogenic drainage and SIMEOX + Autogenic drainage
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteBelgium
- Study dates
- 27 Nov 2019to 30 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 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults with cystic fibrosis
- Chronic bronchorrhea, able to expectorate by themselves
- Hospitalized
Who cannot join
- Regular use of SIMEOX,
- Difficulties in understanding instructions,
- Severe cardiac comorbidity.
Trial locations and contacts
1 site in 1 country.
Belgium1 site
Cliniques universitaires Saint-Luc
Brussels, Brussels Capital, 1200
About this study
Official title: Effects of the Addition of the SIMEOX Device on Autogenic Drainage in Patients With Cystic Fibrosis
This study will investigate the contribution of SIMEOX technology on the effectiveness of bronchial drainage.
This is a crossover study to evaluate the contribution of SIMEOX on the effectiveness of bronchial drainage (verified by the amount of sputum secretions, the rheology of sputum secretions and the subjective sensation of ease of sputum) in patients with cystic fibrosis.
Patients will perform, in randomized order (1) a 30-min session of autogenic drainage, (2) a 30-min session of autogenic drainage with the SIMEOX device. Sputum will be collected during and after the session. The two sessions will be performed with minimum washout time of 24 hours.
- Conditions
- Cystic Fibrosis
- Being tested
- Autogenic drainage, SIMEOX + Autogenic drainage
- Medical subject headings
- Cystic Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Autogenic drainageOther
Autogenic drainage is an airway clearance technique characterised by breathing control using expiratory airflow to mobilise secretions from smaller to larger airways. The secretions will be collected during the physiotherapy session and during the 24 hours following the session.
SIMEOX + Autogenic drainageDevice
SIMEOX is a device generating a succession of gentle depression at the mouth during the expiratory phase associated with autogenic drainage.
| Study group | Role | What they receive |
|---|---|---|
| Autogenic drainage | Active comparator | Patients will have to perform a 30-min session of autogenic drainage. Sputum will be collected during the session. Receives: Other: Autogenic drainage |
| SIMEOX + Autogenic drainage | Active comparator | Patients will have to perform a 30-min session of autogenic drainage with the SIMEOX device. Sputum will be collected during the session. Receives: Device: SIMEOX + Autogenic drainage |
What is being measured
The primary outcome is the main question the study is designed to answer.
Amount of sputum secretion
Total wet weight and dry weight of sputum collected in the 24-h following each intervention will be quantified.
Measured: 30-min
Mucus viscoelasticity
Change in rheological properties of the sputum before and after each intervention will be analyzed using a rheometer. We will use the Rheomuco (Rheonova) reometer to obtain the differences in elasticity (G'), viscosity (G')' and elastic modulus ratio (tanδ) of the secretions collected before and after each intervention.
Measured: 30-min
Subjective feeling of ease to expectorate
A Visual Analogue Scale (VAS) will be used to measure subjective feeling of ease of expectoration during each intervention.
The visual analogue scale (VAS) is a semi-objective rating system that will be used to quantify the subjective feeling of ease to expectorate. The VAS is represented by a horizontal line marked 0 to 10, where "0" indicates "very easy to expectorate" and "10" indicates "not easy to expectorate at all". The lower the score, the easier it is to expectorate.
Measured: 3-min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2019
- Study start27 Nov 2019
- Primary completion30 Nov 2021
- Study completion30 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cystic FibrosisStudies 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
- 20 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
- NCT04187924
- Sponsor's protocol ID
- SIMEOX-003
- Status last verified
- May 2024
- First submitted
- 27 Nov 2019
- Last updated
- 8 May 2024
- 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 8 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of the Addition of the SIMEOX Device on Autogenic Drainage in Patients With Cystic Fibrosis
- ClinicalTrials.gov ID
- NCT04187924
- Acronym / sponsor ID
- SIMEOX-003
- Conditions
- Cystic Fibrosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Cliniques universitaires Saint-Luc- Université Catholique de LouvainUniversity, hospital or other
- Study start
- 27 Nov 2019 (actual)
- Primary completion
- 30 Nov 2021 (actual)
- Study completion
- 30 Nov 2021 (actual)
- First posted
- 5 Dec 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 contribution of SIMEOX technology on the effectiveness of bronchial drainage.
This is a crossover study to evaluate the contribution of SIMEOX on the effectiveness of bronchial drainage (verified by the amount of sputum secretions, the rheology of sputum secretions and the subjective sensation of ease of sputum) in patients with cystic fibrosis.
Patients will perform, in randomized order (1) a 30-min session of autogenic drainage, (2) a 30-min session of autogenic drainage with the SIMEOX device. Sputum will be collected during and after the session. The two sessions will be performed with minimum washout time of 24 hours.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Autogenic drainage | Active comparator | Other: Autogenic drainagePatients will have to perform a 30-min session of autogenic drainage. Sputum will be collected during the session. |
| SIMEOX + Autogenic drainage | Active comparator | Device: SIMEOX + Autogenic drainagePatients will have to perform a 30-min session of autogenic drainage with the SIMEOX device. Sputum will be collected during the session. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adults with cystic fibrosis
- Chronic bronchorrhea, able to expectorate by themselves
- Hospitalized
Key exclusion criteria (3 listed)
- Regular use of SIMEOX,
- Difficulties in understanding instructions,
- Severe cardiac comorbidity.
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 |
|---|---|---|
| Autogenic drainageAutogenic drainage is an airway clearance technique characterised by breathing control using expiratory airflow to mobilise secretions from smaller to larger airways. The secretions will be collected during the physiotherapy session and during the 24 hours following the session. | Other | Autogenic drainage |
| SIMEOX + Autogenic drainageSIMEOX is a device generating a succession of gentle depression at the mouth during the expiratory phase associated with autogenic drainage. | Device | SIMEOX + Autogenic drainage |
Primary outcome
Amount of sputum secretion
Time frame: 30-min
Total wet weight and dry weight of sputum collected in the 24-h following each intervention will be quantified.
Mucus viscoelasticity
Time frame: 30-min
Change in rheological properties of the sputum before and after each intervention will be analyzed using a rheometer. We will use the Rheomuco (Rheonova) reometer to obtain the differences in elasticity (G'), viscosity (G')' and elastic modulus ratio (tanδ) of the secretions collected before and after each intervention.
Subjective feeling of ease to expectorate
Time frame: 3-min
A Visual Analogue Scale (VAS) will be used to measure subjective feeling of ease of expectoration during each intervention. The visual analogue scale (VAS) is a semi-objective rating system that will be used to quantify the subjective feeling of ease to expectorate. The VAS is represented by a horizontal line marked 0 to 10, where "0" indicates "very easy to expectorate" and "10" indicates "not easy to expectorate at all". The lower the score, the easier it is to expectorate.
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 8 May 2024.
- Individual participant dataSharing planned: No
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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.
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 Autogenic drainage and SIMEOX + Autogenic drainage in people with Cystic Fibrosis, 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 3 inclusion and 3 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 8 May 2024. 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?
Amount of sputum secretion (time frame: 30-min). The study lists 3 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 8 May 2024.