Clinical Study to Assess Change in Upper Airway Geometry Between Upright and Supine Position

Study Overview
=================
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.

Official Title
-----------------
Clinical Study to Assess Change in Upper Airway Geometry Between Upright and Supine Position

Conditions
-----------------
Changes in Upper Airway Geometry

Intervention / Treatment
-----------------
* Radiation: Cone Beam Computed Tomography
* Radiation: High Resolution Computed Tomography


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Radiation: Cone Beam Computed Tomography|CBCT scan of upper airway, in upright position.|
|Radiation: High Resolution Computed Tomography|HRCT scan of upper airway, in supine position.|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in upper airway geometry | 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. | At day 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body mass index (BMI) | In addition the effect of elevated BMI on the changes in upper airway morphology will be assessed. | At screening and also at day 1 (if interval screening - day 1 > 14 days) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
High Resolution Computed Tomography, Cone Beam Computed Tomography, upper airway, geometry