Influence of Mouthpiece Design on Upper Airway Geometry
Conditions
Keywords
Functional Respiratory Imaging, Magnetic Resonance Imaging, MRI, Pharyngometry, Upper Airway, Mouthpiece of Inhaler, Cone Beam Computed Tomography, CBCT, Computed Tomography, CT
Brief 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. 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.
Interventions
RADIATIONMagnetic Resonance imaging
11 MRI scans per subject will be taken, one for each mouthpiece design of an inhaler.
OTHERPharyngometry
Pharyngometry will be carried out in supine and upright position. 11 different mouthpieces will be evaluated in both positions.
RADIATIONComputed Tomography 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.
RADIATIONCone Beam Computed Tomography 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.
OTHERDental impressions
Dental impressions will be taken. These will be optically scanned before registration in the 3D imaging modalities.
Sponsors
FLUIDDA nv
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* 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.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in upper airway geometry by using MRI. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in upper airway geometry by using pharyngometry in supine versus upright position. | Within 20 days after day 1 | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Evaluate time dependence on image upper airway by using CT scan | At day 1 | With a high resolution computed tomography (HRCT) scan it's possible to obtain high resolution images in a very short period of time at a low radiation dose. Therefore the 3D CT image of the upper airway will be compared with the one from MRI for 1 mouthpiece to check the time dependence. MRI takes about 50 seconds and CT only 3-4 seconds. |
| 3D image of upper airway in upright position by using CBCT scan | At day 1 | To make a comparison between the upright and supine upper airway geometry the CBCT will be used to provide a 3D image of the upper airway in an upright position. This image will be compared with the 3D MRI image for 1 mouthpiece. |
Countries
Belgium
Outcome results
None listed