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

NCT01594164 | Completed Phase 1

• 1 other identifier: FLUI-2010-61
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Changes in Upper Airway Geometry

Keywords

High Resolution Computed Tomography; Cone Beam Computed Tomography; upper airway; geometry

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Body mass index (BMI)

  At screening and also at day 1 (if interval screening - day 1 > 14 days)

Interventions

Cone Beam Computed Tomography RADIATION

CBCT scan of upper airway, in upright position.

Also known as: CBCT

High Resolution Computed Tomography RADIATION

HRCT scan of upper airway, in supine position.

Also known as: HRCT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• FLUIDDA nv: lead

Study Sites (1)

Antwerp University Hospital

Edegem, Antwerp, 2650, Belgium

Location

Study Officials

• Wilfried De Backer, MD, PhD

  University Hospital, Antwerp

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 3, 2012
• First Posted: May 8, 2012
• Study Start: March 1, 2011
• Primary Completion: April 1, 2011
• Study Completion: April 1, 2011
• Last Updated: October 22, 2012

Record last verified: 2012-10

Locations

BE (1)