Changes in Upper Airway Geometry
Conditions
Keywords
High Resolution Computed Tomography, Cone Beam Computed Tomography, upper airway, geometry
Brief summary
In this study the changes in upper airway geometry and resistance between images, obtained in upright and supine position, will be evaluated. Therefore a Cone Beam Computed Tomography (CBCT) scan and a low dose Computed Tomography (CT) scan will be taken in a population of 20 subjects. The upright morphology will be obtained using CBCT scan while the supine upper airway geometry will be determined using a standard High Resolution Computed Tomography (HRCT) scanner.
Interventions
RADIATIONCone Beam Computed Tomography
CBCT scan of upper airway, in upright position.
RADIATIONHigh Resolution Computed Tomography
HRCT scan of upper airway, in supine position.
Sponsors
FLUIDDA nv
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Written informed consent obtained. * Male or female subject aged ≥ 18 years. * BMI \< 25 kg/m2 (group 1), BMI ≥ 25 kg/m2 and \< 30 kg/m2 (group 2) and BMI ≥ 30 kg/m2 (group 3) at visit 0. BMI calculation should be repeated if the interval visit 0 - visit 1 \> 14 days. * Female subject of childbearing potential who confirms that a contraception method was used at least two months before visit 1.
Exclusion criteria
* Subject is under the age of legal consent. * Subject who is pregnant or is breast-feeding. * Subject with a history of surgery of the upper airway. * Subject with a history of any illness that, in opinion of the investigator, might confound the results of the study or poses an additional risk to the subject by participation in the study. * Subject 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. * Subject who has claustrophobia.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in upper airway geometry | At day 1 | The primary objective of this study is to compare the volume and resistance of the upper airway in supine versus upright position using High Resolution Computed Tomography (HRCT) and Cone Beam Computed Tomography (CBCT) images. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Body mass index (BMI) | At screening and also at day 1 (if interval screening - day 1 > 14 days) | In addition the effect of elevated BMI on the changes in upper airway morphology will be assessed. |
Countries
Belgium
Outcome results
None listed