Evaluation With Scans and Pharyngometry of the Possible Changes in Upper Airway Geometry Induced by Using Different Mouthpieces.

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.

Conditions

• Influence of Mouthpiece Design on Upper Airway Geometry

Interventions

RADIATION

Magnetic Resonance imaging

11 MRI scans per subject will be taken, one for each mouthpiece design of an inhaler.

OTHER

Pharyngometry

Pharyngometry will be carried out in supine and upright position. 11 different mouthpieces will be evaluated in both positions.

RADIATION

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.

RADIATION

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.

OTHER

Dental impressions

Dental impressions will be taken. These will be optically scanned before registration in the 3D imaging modalities.

Sponsors & Collaborators

• FLUIDDA nv

  lead INDUSTRY

Principal Investigators

• Wilfried De Backer, MD, PhD · University Hospital, Antwerp

Study Design

Allocation

NA

Purpose

OTHER

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

MALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2012-09-30

Primary Completion

2012-10-31

Completion

2012-10-31

Countries

• Belgium

Study Locations