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Completed

NCT Number: NCT01592929

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

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.

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Key information

Conditions

Influence of Mouthpiece Design on Upper Airway Geometry

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Antwerp University Hospital

Edegem, Antwerp, 2650, Belgium

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Magnetic resonance imaging

Radiation

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

Other names: 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.

Other names: 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.

Other names: CBCT scan

dental impressions

Other

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

Other outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

FLUIDDA nv

Industry

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
May 7, 2012
Registry last updated
Oct 4, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.