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

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

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.

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.