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.

Study Overview

• Status: Completed
• Conditions: Changes in Upper Airway Geometry
• Intervention / Treatment: Radiation: Cone Beam Computed Tomography; Radiation: High Resolution Computed Tomography

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Phase 1

Contacts and Locations

Study Locations

• Belgium
  • Antwerp
    • Edegem, Antwerp, Belgium, 2650
      • Antwerp University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

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)

Collaborators and Investigators

• Sponsor: FLUIDDA nv

Study record dates

Study Major Dates

• Study Start: March 1, 2011
• Primary Completion (Actual): April 1, 2011
• Study Completion (Actual): April 1, 2011

Study Registration Dates

• First Submitted: May 3, 2012
• First Submitted That Met QC Criteria: May 7, 2012
• First Posted (Estimate): May 8, 2012

Study Record Updates

• Last Update Posted (Estimate): October 22, 2012
• Last Update Submitted That Met QC Criteria: October 19, 2012
• Last Verified: October 1, 2012

More Information

Terms related to this study

• Keywords: upper airway; Cone Beam Computed Tomography; High Resolution Computed Tomography; geometry
• Other Study ID Numbers: FLUI-2010-61