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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
History of Changes
  Purpose

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.


Condition Intervention Phase
Changes in Upper Airway Geometry
 Radiation: Cone Beam Computed Tomography
Radiation: High Resolution Computed Tomography
 Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: Clinical Study to Assess Change in Upper Airway Geometry Between Upright and Supine Position

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by FluidDA nv:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Enrollment: 20
Study Start Date: March 2011
Study Completion Date: April 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    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
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01594164

Locations
Belgium
Antwerp University Hospital
Edegem, Antwerp, Belgium, 2650
Sponsors and Collaborators
FluidDA nv
Investigators
Principal Investigator: Wilfried De Backer, MD, PhD University Hospital, Antwerp
  More Information

No publications provided

Responsible Party: FluidDA nv
ClinicalTrials.gov Identifier: NCT01594164     History of Changes
Other Study ID Numbers: FLUI-2010-61
Study First Received: May 3, 2012
Last Updated: October 19, 2012
Health Authority: Belgium: Ethics Committee

Keywords provided by FluidDA nv:
High Resolution Computed Tomography
Cone Beam Computed Tomography
upper airway
geometry

ClinicalTrials.gov processed this record on May 19, 2013