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

FLUIDDA

Status

Completed

Conditions

Influence of Mouthpiece Design on Upper Airway Geometry

Treatments

Other: Dental impressions

Other: Pharyngometry

Radiation: Cone Beam Computed Tomography scan

Radiation: Magnetic Resonance imaging

Radiation: Computed Tomography scan

Study type

Interventional

Funder types

Industry

Identifiers

NCT01592929

FLUI-2011-80

Details and patient eligibility

About

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.

Enrollment

12 patients

Sex

Male

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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.