Influence of Mouthpiece Design on Upper Airway GeometryNCT01592929
Evaluation With Scans and Pharyngometry of the Possible Changes in Upper Airway Geometry Induced by Using Different Mouthpieces.
A study testing Magnetic Resonance imaging, Pharyngometry and Computed Tomography scan in people with Influence of Mouthpiece Design on Upper Airway Geometry, run by FLUIDDA nv at 1 site in Belgium.
Trial summary
In this study the possible changes in upper airway geometry induced by variations in the characteristics of the mouthpieces of inhalers will be evaluated with functional respiratory imaging (FRI) and Pharyngometry. The study population consists of 12 healthy male subjects. Read more about this study
- Who is it for?
- Ages 18 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Influence of Mouthpiece Design on Upper Airway Geometry
- What is being tested?
- Magnetic Resonance imaging, Pharyngometry and Computed Tomography scan
- Type of treatment
- Surgery or procedure
- How many people
- 12 participants
- Where
- 1 siteBelgium
- Study dates
- Sep 2012to Oct 2012
- 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 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male subject ≥ 18 years old
- Written informed consent obtained
- BMI ≥ 20 kg/m2 and < 25 kg/m2
- Height ≥ 175 cm and ≤ 185 cm
- Subject must be able to understand and complete the protocol requirements, instructions and protocol-stated restrictions.
Who cannot join
- Subject with claustrophobia
- Subject with a history of surgery of the upper airway
- Subject with an enlarged thyroid gland
- Subject with intra-oral piercings
- Subject with dental bracket
- Subject with a pacemaker or another implant that is likely to interfere with the MRI procedure
- Subject that is unlikely to comply with the protocol or unable to understand the nature, scope and possible consequences of the study
- Subject who received any investigational new drug within the last 4 weeks prior to visit 1.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessment of the Effect of the Shape of an Inhaler's Mouthpiece on Upper Airway Geometry, Using Functional Respiratory Imaging and Pharyngometry.
In this study the possible changes in upper airway geometry induced by variations in the characteristics of the mouthpieces of inhalers will be evaluated with functional respiratory imaging (FRI) and Pharyngometry. The study population consists of 12 healthy male subjects.
Different mouthpiece designs will be evaluated for each subject by using magnetic resonance imaging (MRI) scans. The results will help to identify the influence of the height, width, protrusion and resistance of the mouthpiece on upper airway geometry.
Read more
Pharyngometry profiles of all subjects, whilst inhaling through different mouthpiece variants, in supine and upright position, will be completed.
A computed tomography (CT) scan and a cone beam computed tomography (CBCT) scan of the upper airway will be taken to respectively compare the time dependence on 3D imaging with MRI and to provide a 3D image in an upright position.
Dental impressions will be optically scanned to obtain a more accurate representation of the oral cavity, mainly in MRI.
- Being tested
- Magnetic Resonance imaging, Pharyngometry, Computed Tomography scan, Cone Beam Computed Tomography scan, Dental impressions
- Keywords
- Functional Respiratory Imaging, Magnetic Resonance Imaging, MRI, Pharyngometry, Upper Airway, Mouthpiece of Inhaler, Cone Beam Computed Tomography, CBCT, Computed Tomography, CT
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnetic Resonance imagingRadiation
Also called MRI
11 MRI scans per subject will be taken, one for each mouthpiece design of an inhaler.
PharyngometryOther
Pharyngometry will be carried out in supine and upright position. 11 different mouthpieces will be evaluated in both positions.
Computed Tomography scanRadiation
Also called CT scan
One low dose CT scan of the upper airway will be taken. The scan will be taken at normal inhalation through a mouthpiece with moderate resistance.
Cone Beam Computed Tomography scanRadiation
Also called CBCT scan
One CBCT scan of the upper airway will be taken. The scan will be taken at normal respiration through a mouthpiece with moderate resistance.
Dental impressionsOther
Dental impressions will be taken. These will be optically scanned before registration in the 3D imaging modalities.
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in upper airway geometry by using MRI.
The primary objective of this study is to evaluate with MRI-FRI the possible changes in upper airway geometry induced by using different mouthpieces.
Measured: Within 20 days after day 1
Secondary outcomes (1)
Changes in upper airway geometry by using pharyngometry in supine versus upright position.
Secondary the assessment of the effect of using different mouthpieces on changes in upper airway geometry by using pharyngometry in supine versus upright position will be performed.
Measured: Within 20 days after day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2012 (estimated)
- Study startSep 2012
- Primary completionOct 2012
- Study completionOct 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Influence of Mouthpiece Design on Upper Airway GeometryStudies of the same condition, open and under way.
- 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- FLUIDDA nv
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Wilfried De Backer, MD, PhD, Principal investigator, University Hospital, Antwerp
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01592929
- Sponsor's protocol ID
- FLUI-2011-80
- Status last verified
- Nov 2012
- First submitted
- 4 May 2012
- Last updated
- 4 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Effect of the Shape of an Inhaler's Mouthpiece on Upper Airway Geometry, Using Functional Respiratory Imaging and Pharyngometry.
- ClinicalTrials.gov ID
- NCT01592929
- Acronym / sponsor ID
- FLUI-2011-80
- Keywords
- Functional Respiratory Imaging, Magnetic Resonance Imaging, MRI, Pharyngometry, Upper Airway, Mouthpiece of Inhaler, Cone Beam Computed Tomography, CBCT
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- FLUIDDA nvIndustry (pharma, biotech, devices)
- Study start
- Sep 2012
- Primary completion
- Oct 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 7 May 2012 (estimated)
- 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.
In this study the possible changes in upper airway geometry induced by variations in the characteristics of the mouthpieces of inhalers will be evaluated with functional respiratory imaging (FRI) and Pharyngometry. The study population consists of 12 healthy male subjects.
Different mouthpiece designs will be evaluated for each subject by using magnetic resonance imaging (MRI) scans. The results will help to identify the influence of the height, width, protrusion and resistance of the mouthpiece on upper airway geometry.
Pharyngometry profiles of all subjects, whilst inhaling through different mouthpiece variants, in supine and upright position, will be completed.
A computed tomography (CT) scan and a cone beam computed tomography (CBCT) scan of the upper airway will be taken to respectively compare the time dependence on 3D imaging with MRI and to provide a 3D image in an upright position.
Dental impressions will be optically scanned to obtain a more accurate representation of the oral cavity, mainly in MRI.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male subject ≥ 18 years old
- Written informed consent obtained
- BMI ≥ 20 kg/m2 and < 25 kg/m2
- Height ≥ 175 cm and ≤ 185 cm
- Subject must be able to understand and complete the protocol requirements, instructions and protocol-stated restrictions.
Key exclusion criteria (8 listed)
- Subject with claustrophobia
- Subject with a history of surgery of the upper airway
- Subject with an enlarged thyroid gland
- Subject with intra-oral piercings
- Subject with dental bracket
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 |
|---|---|---|
| Magnetic Resonance imagingAlso: MRI11 MRI scans per subject will be taken, one for each mouthpiece design of an inhaler. | Radiation | – |
| PharyngometryPharyngometry will be carried out in supine and upright position. 11 different mouthpieces will be evaluated in both positions. | Other | – |
| Computed Tomography scanAlso: CT scanOne low dose CT scan of the upper airway will be taken. The scan will be taken at normal inhalation through a mouthpiece with moderate resistance. | Radiation | – |
| Cone Beam Computed Tomography scanAlso: CBCT scanOne CBCT scan of the upper airway will be taken. The scan will be taken at normal respiration through a mouthpiece with moderate resistance. | Radiation | – |
| Dental impressionsDental impressions will be taken. These will be optically scanned before registration in the 3D imaging modalities. | Other | – |
Primary outcome
Changes in upper airway geometry by using MRI.
Time frame: Within 20 days after day 1
The primary objective of this study is to evaluate with MRI-FRI the possible changes in upper airway geometry induced by using different mouthpieces.
1 secondary outcome
Changes in upper airway geometry by using pharyngometry in supine versus upright position.
Time frame: Within 20 days after day 1
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 4 Oct 2017.
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.
Wilfried De Backer, MD, PhD principal investigator
University Hospital, Antwerp
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Magnetic Resonance imaging, Pharyngometry and Computed Tomography scan in people with Influence of Mouthpiece Design on Upper Airway Geometry, run by FLUIDDA nv 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 5 inclusion and 8 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 4 Oct 2017. 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?
Changes in upper airway geometry by using MRI. (time frame: Within 20 days after day 1). 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 4 Oct 2017.