Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Magnetic Resonance imaging | Radiation | 11 MRI scans per subject will be taken, one for each mouthpiece design of an inhaler. |
| |
| Pharyngometry | Other | Pharyngometry will be carried out in supine and upright position. 11 different mouthpieces will be evaluated in both positions. | ||
| Computed Tomography scan | Radiation | 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 scan | Radiation | 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 impressions | Other |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Within 20 days after day 1 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Within 20 days after day 1 |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate time dependence on image upper airway by using CT scan | 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. | At day 1 |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Wilfried De Backer, MD, PhD | University Hospital, Antwerp | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Antwerp University Hospital | Edegem | Antwerp | 2650 | Belgium |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Dental impressions will be taken. These will be optically scanned before registration in the 3D imaging modalities. |
| 3D image of upper airway in upright position by using CBCT scan | 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. | At day 1 |
| ID | Term |
|---|---|
| D009682 | Magnetic Resonance Spectroscopy |
| D003761 | Dental Impression Technique |
| ID | Term |
|---|---|
| D013057 | Spectrum Analysis |
| D002623 | Chemistry Techniques, Analytical |
| D008919 | Investigative Techniques |
| D013674 | Technology, Dental |
| D003813 | Dentistry |
Not provided
Not provided