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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
FluidDA nv
ClinicalTrials.gov Identifier:
NCT01592929
First received: May 4, 2012
Last updated: November 20, 2012
Last verified: November 2012
  Purpose

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.


Condition Intervention
Influence of Mouthpiece Design on Upper Airway Geometry.
Radiation: Magnetic Resonance imaging
Other: Pharyngometry
Radiation: Computed Tomography scan
Radiation: Cone Beam Computed Tomography scan
Other: Dental impressions

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: Assessment of the Effect of the Shape of an Inhaler's Mouthpiece on Upper Airway Geometry, Using Functional Respiratory Imaging and Pharyngometry.

Resource links provided by NLM:


Further study details as provided by FluidDA nv:

Primary Outcome Measures:
  • Changes in upper airway geometry by using MRI. [ Time Frame: Within 20 days after day 1 ] [ Designated as safety issue: No ]
    The primary objective of this study is to evaluate with MRI-FRI the possible changes in upper airway geometry induced by using different mouthpieces.


Secondary Outcome Measures:
  • Changes in upper airway geometry by using pharyngometry in supine versus upright position. [ Time Frame: Within 20 days after day 1 ] [ Designated as safety issue: No ]
    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.


Other Outcome Measures:
  • Evaluate time dependence on image upper airway by using CT scan [ Time Frame: At day 1 ] [ Designated as safety issue: No ]
    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.

  • 3D image of upper airway in upright position by using CBCT scan [ Time Frame: At day 1 ] [ Designated as safety issue: No ]
    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.


Enrollment: 12
Study Start Date: September 2012
Study Completion Date: October 2012
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    Radiation: Magnetic Resonance imaging
    11 MRI scans per subject will be taken, one for each mouthpiece design of an inhaler.
    Other Name: MRI
    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.
    Other Name: CT scan
    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 Name: CBCT scan
    Other: Dental impressions
    Dental impressions will be taken. These will be optically scanned before registration in the 3D imaging modalities.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01592929

Locations
Belgium
Antwerp University Hospital
Edegem, Antwerp, Belgium, 2650
Sponsors and Collaborators
FluidDA nv
Investigators
Principal Investigator: Wilfried De Backer, MD, PhD University Hospital, Antwerp
  More Information

No publications provided

Responsible Party: FluidDA nv
ClinicalTrials.gov Identifier: NCT01592929     History of Changes
Other Study ID Numbers: FLUI-2011-80
Study First Received: May 4, 2012
Last Updated: November 20, 2012
Health Authority: Belgium: Ethics Committee

Keywords provided by FluidDA nv:
Functional Respiratory Imaging
Magnetic Resonance Imaging
MRI
Pharyngometry
Upper Airway
Mouthpiece of Inhaler
Cone Beam Computed Tomography
CBCT
Computed Tomography
CT

ClinicalTrials.gov processed this record on July 29, 2014