Evaluation With Scans and Pharyngometry of the Possible Changes in Upper Airway Geometry Induced by Using Different Mouthpieces.
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.
|Influence of Mouthpiece Design on Upper Airway Geometry.||Radiation: Magnetic Resonance imaging Other: Pharyngometry Radiation: Computed Tomography scan Radiation: Cone Beam Computed Tomography scan Other: Dental impressions|
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
|Official Title:||Assessment of the Effect of the Shape of an Inhaler's Mouthpiece on Upper Airway Geometry, Using Functional Respiratory Imaging and Pharyngometry.|
- 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.
- Changes in upper airway geometry by using pharyngometry in supine versus upright position. [ Time Frame: 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.
- Evaluate time dependence on image upper airway by using CT scan [ Time Frame: 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 [ Time Frame: 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.
|Study Start Date:||September 2012|
|Study Completion Date:||October 2012|
|Primary Completion Date:||October 2012 (Final data collection date for primary outcome measure)|
Radiation: Magnetic Resonance imaging
Please refer to this study by its ClinicalTrials.gov identifier: NCT01592929
|Antwerp University Hospital|
|Edegem, Antwerp, Belgium, 2650|
|Principal Investigator:||Wilfried De Backer, MD, PhD||University Hospital, Antwerp|