NCT01592929

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

Assessment of the Effect of the Shape of an Inhaler's Mouthpiece on Upper Airway Geometry, Using Functional Respiratory Imaging and Pharyngometry.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: FLUIDDA nv · Industry
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Accepted

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

Type	Name	Description
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.

Timeline

• Start date: 2012-09-01
• Primary completion: 2012-10-01
• Completion: 2012-10-01
• First posted: 2012-05-07
• Last updated: 2017-10-04

Locations

1 site across 1 country: Belgium