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

Study Overview
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Brief Summary
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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.

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

Conditions
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Influence of Mouthpiece Design on Upper Airway Geometry

Intervention / Treatment
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* Radiation: Magnetic Resonance imaging
* Other: Pharyngometry
* Radiation: Computed Tomography scan
* Radiation: Cone Beam Computed Tomography scan
* Other: Dental impressions


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|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.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in upper airway geometry by using MRI. | The primary objective of this study is to evaluate with MRI-FRI the possible changes in upper airway geometry induced by using different mouthpieces. | Within 20 days after day 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in upper airway geometry by using pharyngometry in supine versus upright position. | Secondary the assessment of the effect of using different mouthpieces on changes in upper airway geometry by using pharyngometry in supine versus upright position will be performed. | Within 20 days after day 1 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Functional Respiratory Imaging, Magnetic Resonance Imaging, MRI, Pharyngometry, Upper Airway, Mouthpiece of Inhaler, Cone Beam Computed Tomography, CBCT, Computed Tomography, CT