Influence of Mouthpiece Design on Upper Airway Geometry Clinical Trial
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.
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.
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