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

October 2, 2017 updated by: FLUIDDA nv

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

12

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
    • Antwerp
      • Edegem, Antwerp, Belgium, 2650
        • Antwerp University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: OTHER
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in upper airway geometry by using MRI.
Time Frame: Within 20 days after day 1
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.
Time Frame: Within 20 days after day 1
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

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluate time dependence on image upper airway by using CT scan
Time Frame: At day 1
With a high resolution computed tomography (HRCT) scan it's possible to obtain high resolution images in a very short period of time at a low radiation dose. Therefore the 3D CT image of the upper airway will be compared with the one from MRI for 1 mouthpiece to check the time dependence. MRI takes about 50 seconds and CT only 3-4 seconds.
At day 1
3D image of upper airway in upright position by using CBCT scan
Time Frame: At day 1
To make a comparison between the upright and supine upper airway geometry the CBCT will be used to provide a 3D image of the upper airway in an upright position. This image will be compared with the 3D MRI image for 1 mouthpiece.
At day 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

FLUIDDA nv

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2012

Primary Completion (Actual)

October 1, 2012

Study Completion (Actual)

October 1, 2012

Study Registration Dates

First Submitted

May 4, 2012

First Submitted That Met QC Criteria

May 4, 2012

First Posted (Estimate)

May 7, 2012

Study Record Updates

Last Update Posted (Actual)

October 4, 2017

Last Update Submitted That Met QC Criteria

October 2, 2017

Last Verified

November 1, 2012

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • FLUI-2011-80

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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