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OpenTrials
Completed

NCT Number: NCT01594164

Clinical Study to Assess Change in Upper Airway Geometry Between Upright and Supine Position

In this study the changes in upper airway geometry and resistance between images, obtained in upright and supine position, will be evaluated. Therefore a Cone Beam Computed Tomography (CBCT) scan and a low dose Computed Tomography (CT) scan will be taken in a population of 20 subjects. The upright morphology will be obtained using CBCT scan while the supine upper airway geometry will be determined using a standard High Resolution Computed Tomography (HRCT) scanner.

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Key information

Conditions

Changes in Upper Airway Geometry

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

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

  • Written informed consent obtained.
  • Male or female subject aged ≥ 18 years.
  • BMI < 25 kg/m2 (group 1), BMI ≥ 25 kg/m2 and < 30 kg/m2 (group 2) and BMI ≥ 30 kg/m2 (group 3) at visit 0. BMI calculation should be repeated if the interval visit 0 - visit 1 > 14 days.
  • Female subject of childbearing potential who confirms that a contraception method was used at least two months before visit 1.

Exclusion criteria

  • Subject is under the age of legal consent.
  • Subject who is pregnant or is breast-feeding.
  • Subject with a history of surgery of the upper airway.
  • Subject with a history of any illness that, in opinion of the investigator, might confound the results of the study or poses an additional risk to the subject by participation in the study.
  • Subject 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.
  • Subject who has claustrophobia.

Treatment and study plan

Cone Beam Computed Tomography

Radiation

CBCT scan of upper airway, in upright position.

Other names: CBCT

High Resolution Computed Tomography

Radiation

HRCT scan of upper airway, in supine position.

Other names: HRCT

Primary outcomes

  1. Changes in upper airway geometry

    Time frame: At day 1

    The primary objective of this study is to compare the volume and resistance of the upper airway in supine versus upright position using High Resolution Computed Tomography (HRCT) and Cone Beam Computed Tomography (CBCT) images.

Secondary outcomes

  1. Body mass index (BMI)

    Time frame: At screening and also at day 1 (if interval screening - day 1 > 14 days)

    In addition the effect of elevated BMI on the changes in upper airway morphology will be assessed.

Sponsors and collaborators

Lead sponsor

FLUIDDA nv

Industry

Registry information

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
May 8, 2012
Registry last updated
Oct 22, 2012

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.