Clinical Study to Assess Change in Upper Airway Geometry Between Upright and Supine Position
NCT ID: NCT01594164
Last Updated: 2012-10-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
20 participants
INTERVENTIONAL
2011-03-31
2011-04-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
NONE
Interventions
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Cone Beam Computed Tomography
CBCT scan of upper airway, in upright position.
High Resolution Computed Tomography
HRCT scan of upper airway, in supine position.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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.
18 Years
ALL
Yes
Sponsors
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FLUIDDA nv
INDUSTRY
Responsible Party
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Principal Investigators
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Wilfried De Backer, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Antwerp
Locations
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Antwerp University Hospital
Edegem, Antwerp, Belgium
Countries
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Other Identifiers
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FLUI-2010-61
Identifier Type: -
Identifier Source: org_study_id