Clinical Study to Assess Change in Upper Airway Geometry Between Upright and Supine Position
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government.
Read our disclaimer for details.
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.
Condition or disease
Changes in Upper Airway Geometry
Radiation: Cone Beam Computed TomographyRadiation: High Resolution Computed Tomography
Changes in upper airway geometry [ Time Frame: 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 Outcome Measures :
Body mass index (BMI) [ Time Frame: 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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study:
18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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.
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.