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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
FluidDA nv
ClinicalTrials.gov Identifier:
NCT01594164
First received: May 3, 2012
Last updated: October 19, 2012
Last verified: October 2012

May 3, 2012
October 19, 2012
March 2011
April 2011   (final data collection date for primary outcome measure)
Changes in upper airway geometry [ Time Frame: At day 1 ] [ Designated as safety issue: No ]
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.
Same as current
Complete list of historical versions of study NCT01594164 on ClinicalTrials.gov Archive Site
Body mass index (BMI) [ Time Frame: At screening and also at day 1 (if interval screening - day 1 > 14 days) ] [ Designated as safety issue: No ]
In addition the effect of elevated BMI on the changes in upper airway morphology will be assessed.
Same as current
Not Provided
Not Provided
 
Clinical Study to Assess Change in Upper Airway Geometry Between Upright and Supine Position
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.

Not Provided
Interventional
Phase 1
Intervention Model: Single Group Assignment
Masking: Open Label
Changes in Upper Airway Geometry
  • Radiation: Cone Beam Computed Tomography
    CBCT scan of upper airway, in upright position.
    Other Name: CBCT
  • Radiation: High Resolution Computed Tomography
    HRCT scan of upper airway, in supine position.
    Other Name: HRCT
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
20
April 2011
April 2011   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
Belgium
 
NCT01594164
FLUI-2010-61
No
FluidDA nv
FluidDA nv
Not Provided
Principal Investigator: Wilfried De Backer, MD, PhD University Hospital, Antwerp
FluidDA nv
October 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP