Clinical trial NCT01592929: Evaluation With Scans and Pharyngometry of the Possible Changes in Upper Airway Geometry Induced by Using Different Mouthpieces.
Official title: Assessment of the Effect of the Shape of an Inhaler's Mouthpiece on Upper Airway Geometry, Using Functional Respiratory Imaging and Pharyngometry.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Influence of Mouthpiece Design on Upper Airway Geometry
Keywords: Functional Respiratory Imaging
Magnetic Resonance Imaging
MRI
Pharyngometry
Upper Airway
Mouthpiece of Inhaler
Cone Beam Computed Tomography
CBCT
Computed Tomography
CT
Lead sponsor: FLUIDDA nv
Sponsor class: INDUSTRY
First posted: 2012-05-07
Enrollment: 12
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: In this study the possible changes in upper airway geometry induced by variations in the characteristics of the mouthpieces of inhalers will be evaluated with functional respiratory imaging (FRI) and Pharyngometry. The study population consists of 12 healthy male subjects.

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.


Eligibility criteria: Inclusion Criteria:

* Male subject ≥ 18 years old
* 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 claustrophobia
* 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.

Primary outcomes:
measure: Changes in upper airway geometry by using MRI.
timeFrame: Within 20 days after day 1
Secondary outcomes:
measure: Changes in upper airway geometry by using pharyngometry in supine versus upright position.
timeFrame: Within 20 days after day 1
Other outcomes:
measure: Evaluate time dependence on image upper airway by using CT scan
timeFrame: At day 1
measure: 3D image of upper airway in upright position by using CBCT scan
timeFrame: At day 1
Locations:
city: Edegem
country: Belgium
facility: Antwerp University Hospital
state: Antwerp
Study officials:
affiliation: University Hospital, Antwerp
name: Wilfried De Backer, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: