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

FLUIDDA nv1 site in 1 country20 target enrollmentMarch 2011

ConditionsChanges in Upper Airway Geometry

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Changes in Upper Airway Geometry
Sponsor: FLUIDDA nv
Enrollment: 20
Locations: 1
Primary Endpoint: Changes in upper airway geometry
Status: Completed
Last Updated: 13 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

March 2011

End Date

April 2011

Last Updated

13 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

FLUIDDA nv

Responsible Party

Sponsor

Eligibility Criteria

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
•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
•Subject who has claustrophobia.

Outcomes

Primary Outcomes

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.