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

Phase 1

Completed

• Conditions: Changes in Upper Airway Geometry

• Registration Number: NCT01594164
• Lead Sponsor: FLUIDDA nv

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-03
• Primary Completion: 2011-04
• Study Completion: 2011-04
• Study First Submitted: 2012-05-03
• Study First Submitted QC: 2012-05-07
• Study First Posted: 2012-05-08
• Status Verified: 2012-10
• Last Update Submitted: 2012-10-19
• Last Update Posted: 2012-10-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Antwerp University Hospital; 🇧🇪 Edegem, Antwerp, Belgium