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

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ClinicalTrials.gov Identifier: NCT01594164
Recruitment Status : Completed
First Posted : May 8, 2012
Last Update Posted : October 22, 2012
Sponsor:
Information provided by (Responsible Party):
FLUIDDA nv

Study Description
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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.

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

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: Clinical Study to Assess Change in Upper Airway Geometry Between Upright and Supine Position
Study Start Date : March 2011
Actual Primary Completion Date : April 2011
Actual Study Completion Date : April 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: CT Scans

Arms and Interventions
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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

Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Body mass index (BMI) [ Time Frame: At screening and also at day 1 (if interval screening - day 1 > 14 days) ]
    In addition the effect of elevated BMI on the changes in upper airway morphology will be assessed.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01594164


Locations
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Belgium
Antwerp University Hospital
Edegem, Antwerp, Belgium, 2650
Sponsors and Collaborators
FLUIDDA nv
Investigators
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Principal Investigator: Wilfried De Backer, MD, PhD University Hospital, Antwerp
More Information
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Responsible Party: FLUIDDA nv
ClinicalTrials.gov Identifier: NCT01594164    
Other Study ID Numbers: FLUI-2010-61
First Posted: May 8, 2012    Key Record Dates
Last Update Posted: October 22, 2012
Last Verified: October 2012
Keywords provided by FLUIDDA nv:
High Resolution Computed Tomography
Cone Beam Computed Tomography
upper airway
geometry