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You can access this
clinical trial
if you have
Influence of Mouthpiece Design on Upper Airway Geometry
and you are
over 18
years old
-
The phase for this study is not defined.
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The purpose

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.

Provided treatments

  • Radiation: Magnetic Resonance imaging
  • Other: Pharyngometry
  • Radiation: Computed Tomography scan
  • Radiation: Cone Beam Computed Tomography scan
  • Other: Dental impressions

Locations near you

Unfortunately, there are no recruiting locations near you. Please check the list with all locations below.
Tris trial is registered with FDA with number: NCT01592929. The sponsor of the trial is FLUIDDA nv and it is looking for 12 volunteers for the current phase.
Official trial title:
Assessment of the Effect of the Shape of an Inhaler's Mouthpiece on Upper Airway Geometry, Using Functional Respiratory Imaging and Pharyngometry.