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.
| Verified date | November 2012 |
| Source | FLUIDDA nv |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 12 |
| Est. completion date | October 2012 |
| Est. primary completion date | October 2012 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Male |
| Age group | 18 Years and older |
| Eligibility |
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. |
| Country | Name | City | State |
|---|---|---|---|
| Belgium | Antwerp University Hospital | Edegem | Antwerp |
| Lead Sponsor | Collaborator |
|---|---|
| FLUIDDA nv |
Belgium,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Other | 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 | |
| Other | 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 | |
| Primary | 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 | |
| Secondary | 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 |