Evaluation With Scans and Pharyngometry of the Possible Changes in Upper Airway Geometry Induced by Using Different Mouthpieces.
NCT ID: NCT01592929
Last Updated: 2017-10-04
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
NA
12 participants
INTERVENTIONAL
2012-09-30
2012-10-31
Brief Summary
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Different mouthpiece designs will be evaluated for each subject by using magnetic resonance imaging (MRI) scans. The results will help to identify the influence of the height, width, protrusion and resistance of the mouthpiece on upper airway geometry.
Pharyngometry profiles of all subjects, whilst inhaling through different mouthpiece variants, in supine and upright position, will be completed.
A computed tomography (CT) scan and a cone beam computed tomography (CBCT) scan of the upper airway will be taken to respectively compare the time dependence on 3D imaging with MRI and to provide a 3D image in an upright position.
Dental impressions will be optically scanned to obtain a more accurate representation of the oral cavity, mainly in MRI.
Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
OTHER
NONE
Interventions
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Magnetic Resonance imaging
11 MRI scans per subject will be taken, one for each mouthpiece design of an inhaler.
Pharyngometry
Pharyngometry will be carried out in supine and upright position. 11 different mouthpieces will be evaluated in both positions.
Computed Tomography scan
One low dose CT scan of the upper airway will be taken. The scan will be taken at normal inhalation through a mouthpiece with moderate resistance.
Cone Beam Computed Tomography scan
One CBCT scan of the upper airway will be taken. The scan will be taken at normal respiration through a mouthpiece with moderate resistance.
Dental impressions
Dental impressions will be taken. These will be optically scanned before registration in the 3D imaging modalities.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Written informed consent obtained
* BMI ≥ 20 kg/m2 and \< 25 kg/m2
* Height ≥ 175 cm and ≤ 185 cm
* Subject must be able to understand and complete the protocol requirements, instructions and protocol-stated restrictions.
Exclusion Criteria
* Subject with a history of surgery of the upper airway
* Subject with an enlarged thyroid gland
* Subject with intra-oral piercings
* Subject with dental bracket
* Subject with a pacemaker or another implant that is likely to interfere with the MRI procedure
* Subject that 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.
18 Years
MALE
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-2011-80
Identifier Type: -
Identifier Source: org_study_id