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OSAACAS-3DNCT06022679

CBCT Analysis of the Craniofacial Architecture in Young, Non-overweight Apneic Adult Phenotype

An observational study of OSA, run by Centre Hospitalier Universitaire de Liege at 1 site in Belgium.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This prospective, controlled study will compare the 3D cephalometric analysis of bone and craniofacial soft tissues in young (18-35 years) non-overweight apneic adults phenotype between a test group (with AHI 15) and a control group (healthy subjects with AHI < 15). Read more about this study

Who is it for?
Ages 18 to 35 yearsHealthy volunteers can take part
Conditions the study is for
OSA
What is being tested?
CBCT
How many people
46 participants
Where
1 siteBelgium
Study dates
1 Apr 2022to 1 Apr 2023
Phase
Observational
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 to 35 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Study population: Young people (18-35 years) non-overweight apneic divided into 2 groups: a test group (with AHI 15) and a control group (healthy subjects with AHI < 15).

Who may be able to join

  • (1) patients aged between 18 and 35 years ;
  • (2) Body Mass Index (BMI) lower than 30kg/m² ;
  • (3) alcohol consumption less than 4 unit per day ;
  • (4) tabacco use less than 6 cigarettes per day ;
  • (5) no illicit drug use ; and
  • (6) absence of chronic pathology or medication.

Who cannot join

  • (1) presence of an acute illness on the day of admission ;
  • (2) patients treated with orthognathic surgery after apnea screening ;
  • (3) patients with polysomnography with a sleep treatment device (PPCN or Mandibular advancement device).

Trial locations and contacts

1 site in 1 country.

Belgium1 site
  • CHU Liège, site Brull

    Liège, 4020

Other trials in Belgium

About this study

This prospective, controlled study will compare the 3D cephalometric analysis of bone and craniofacial soft tissues in young (18-35 years) non-overweight apneic adults phenotype between a test group (with AHI 15) and a control group (healthy subjects with AHI < 15).

Read the detailed description

Objectives The goal of this study is to determine an accurate bone and soft tissue phenotype for the non-overweight apneic young adult.

Materials and Methods This study was approved by the ethics medical committee of the University hospital of Liege.

This prospective, controlled study will compare cephalometric 3D analysis of bone and craniofacial soft tissue phenotype of young, non-overweight apneic adults using cephalometric 3D analysis between a test group (with AHI 15) and a control group (healthy subjects with AHI < 15).

The inclusion criteria were : (1) patients aged between 18 and 35 years ; (2) Body Mass Index (BMI) lower than 30kg/m² ; (3) alcohol consumption less than 4 unit per day ; (4) tabacco use less than 6 cigarettes per day ; (5) no illicit drug use ; and (6) absence of chronic pathology or medication.

The exclusion criteria were : (1) presence of an acute illness on the day of admission ; (2) patients treated with orthognathic surgery after apnea screening ; (3) patients with polysomnography with a sleep treatment device (PPCN or Mandibular advancement device).

The test group consisted of 23 patients (9 girls and 14 boys) recruited in polysomnography in sleep center of CHU Liege for suspected sleep disorders between 1 january 2022 and 1 april 2023.

Concerning the control group, the participants, healthy adults volunteers are recruited among friends and families of students who collaborate with sleep center for scientific projects. These subjects have no complaints related to OSA and will have to undergo a sleep examination (ventilatory polygraphy) to certify the absence of OSA. This group consisted of 23 patients (14 girls and 9 boys).

This study takes place in two stages. First, all patient are invited to an initial consultation where question about demographics (age, weight, height, gender) and medical history will be asked. At the end of this consultation, only patient of the control group leave with a sleep monitor to record their sleep for one night.

Afterwards, all patients (test and control group) will be invited to undergo a super low dose CBCT in the supine position at CHU Sart Tilman University Hospital.

Demographics and orthodontics data A general history will be taken, including gender, age, height, weight, medical and surgical history (e.g. presence/absence of tonsils and vegetations), current or past regular medication use, presence of allergies associated with allergic rhinitis, presence of asthma and presence of parafunctions.

Cephalometric data An ultra low dose CBCT ( 300μm resolution) will be performed in each patient with a field of 16x18 cm. A computerized 3D analysis will be performed with Dolphin Imaging 11.95 software. All these tools will allow the collection of the following data: parameters concerning the morphological typology and growth potential, the base of the skull, the maxilla, the mandible, the inter-maxillary relationship, the pharynx, the airways as well as the volumes of the different structures.

Sleep data The data will be collected by means of the epworth sleepiness scale (ESS) and a sleep recording of the polysomnography at the hospital type (AASM type 1 sleep recording) for the test group and of the ventilatory polygraph type (AASM type 3 sleep recording) for the control group.

Conditions
OSA
Being tested
CBCT
Keywords
Young no-overweight adult, OSA, cephalometry, 3D

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CBCTOther

    CBCT examination in supine position A computerized 3D-analysis using Dolphin Imaging 11.95 software was performed in each CBCT.

Study groups in NCT06022679
Study groupRoleWhat they receive
Test group SAHOSThe test group consisted of 23 patients ( 9 girls and 14 boys) recruited on the basis of polysomnography at sleep center of CHU Liege for suspected sleep disorders between 1 january 2022 and 1 april 2023, with IAH >15
Receives: Other: CBCT
Control group no SAHOSConcerning the control group, the participants, adults volunteers are recruited among friends and families of students who collaborate with sleep center for scientific projects. These subjects have no complaints related to OSA and will have to undergo a sleep examination (ventilatory polygraphy) to certify the absence of OSA. This group consisted of 23 patients (14 girls and 9 boys).
Receives: Other: CBCT

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. maxillary volume

    maxillary volume with 3D cephalométric analysis

    Measured: 2month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Sep 2023
  2. Study start1 Apr 2022
  3. Primary completion1 Apr 2023
  4. Study completion1 Apr 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Other
Enrolment
46 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06022679
Sponsor's protocol ID
B7072022000010
Other IDs
2022/72
Acronym
ACAS-3D
Status last verified
Aug 2023
First submitted
16 Aug 2023
Last updated
5 Sep 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Jadoul M, Albert A, Maes N, Poirrier R, Poirrier AL, Bruwier A. Three-dimensional cone beam computed tomography analysis of craniofacial phenotype in nonobese apneic young adults. Laryngoscope Investig Otolaryngol. 2025 Jan 31;10(1):e70061. doi: 10.1002/lio2.70061. eCollection 2025 Feb.

    PubMed 39897118

Questions about this trial

What is this clinical trial studying?

An observational study of OSA, run by Centre Hospitalier Universitaire de Liege 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 6 inclusion and 3 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 5 Sep 2023. 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.

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?

maxillary volume (time frame: 2month). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06022679, which also lists 1 linked publication.

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 5 Sep 2023.

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