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

NCT01592929 | Completed

• 1 other identifier: FLUI-2011-80
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Changes in upper airway geometry by using pharyngometry in supine versus upright position.

  Within 20 days after day 1

Other Outcomes (2)

• Evaluate time dependence on image upper airway by using CT scan

  At day 1

• 3D image of upper airway in upright position by using CBCT scan

  At day 1

Interventions

Magnetic Resonance imaging RADIATION

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

Also known as: MRI

Pharyngometry OTHER

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

Computed Tomography scan RADIATION

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.

Also known as: CT scan

Cone Beam Computed Tomography scan RADIATION

One CBCT scan of the upper airway will be taken. The scan will be taken at normal respiration through a mouthpiece with moderate resistance.

Also known as: CBCT scan

Dental impressions OTHER

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

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• FLUIDDA nv: lead

Study Sites (1)

Antwerp University Hospital

Edegem, Antwerp, 2650, Belgium

Location

MeSH Terms

Interventions

Magnetic Resonance Spectroscopy; Dental Impression Technique

Intervention Hierarchy (Ancestors)

Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques; Technology, Dental; Dentistry

Study Officials

• Wilfried De Backer, MD, PhD

  University Hospital, Antwerp

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 4, 2012
• First Posted: May 7, 2012
• Study Start: September 1, 2012
• Primary Completion: October 1, 2012
• Study Completion: October 1, 2012
• Last Updated: October 4, 2017

Record last verified: 2012-11

Locations

BE (1)