Changes in Upper Airway GeometryPhase 1NCT01594164
Clinical Study to Assess Change in Upper Airway Geometry Between Upright and Supine Position
A Phase 1 study testing Cone Beam Computed Tomography and High Resolution Computed Tomography in people with Changes in Upper Airway Geometry, run by FLUIDDA nv at 1 site in Belgium.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Changes in Upper Airway Geometry
- What is being tested?
- Cone Beam Computed Tomography and High Resolution Computed Tomography
- Type of treatment
- Surgery or procedure
- How many people
- 20 participants
- Where
- 1 siteBelgium
- Study dates
- Mar 2011to Apr 2011
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Changes in Upper Airway Geometry
- Being tested
- Cone Beam Computed Tomography, High Resolution Computed Tomography
- Keywords
- High Resolution Computed Tomography, Cone Beam Computed Tomography, upper airway, geometry
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cone Beam Computed TomographyRadiation
Also called CBCT
CBCT scan of upper airway, in upright position.
High Resolution Computed TomographyRadiation
Also called HRCT
HRCT scan of upper airway, in supine position.
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in upper airway geometry
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.
Measured: At day 1
Secondary outcomes (1)
Body mass index (BMI)
In addition the effect of elevated BMI on the changes in upper airway morphology will be assessed.
Measured: At screening and also at day 1 (if interval screening - day 1 > 14 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2012 (estimated)
- Study startMar 2011
- Primary completionApr 2011
- Study completionApr 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Changes in Upper Airway GeometryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- FLUIDDA nv
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Wilfried De Backer, MD, PhD, Principal investigator, University Hospital, Antwerp
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01594164
- Sponsor's protocol ID
- FLUI-2010-61
- Status last verified
- Oct 2012
- First submitted
- 3 May 2012
- Last updated
- 22 Oct 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study to Assess Change in Upper Airway Geometry Between Upright and Supine Position
- ClinicalTrials.gov ID
- NCT01594164
- Acronym / sponsor ID
- FLUI-2010-61
- Conditions
- Changes in Upper Airway Geometry
- Keywords
- High Resolution Computed Tomography, Cone Beam Computed Tomography, upper airway, geometry
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- FLUIDDA nvIndustry (pharma, biotech, devices)
- Study start
- Mar 2011
- Primary completion
- Apr 2011 (actual)
- Study completion
- Apr 2011 (actual)
- First posted
- 8 May 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cone Beam Computed TomographyAlso: CBCTCBCT scan of upper airway, in upright position. | Radiation | – |
| High Resolution Computed TomographyAlso: HRCTHRCT scan of upper airway, in supine position. | Radiation | – |
Primary outcome
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.
1 secondary outcome
Body mass index (BMI)
Time frame: At screening and also at day 1 (if interval screening - day 1 > 14 days)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2012.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wilfried De Backer, MD, PhD principal investigator
University Hospital, Antwerp
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Cone Beam Computed Tomography and High Resolution Computed Tomography in people with Changes in Upper Airway Geometry, run by FLUIDDA nv at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Oct 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in upper airway geometry (time frame: At day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2012.