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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

46 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-04-01

Study Completion Date

2023-04-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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).

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Three Dimensional Morphology of Upper Respiratory Tract and Mandibular Position on Obstructive Sleep Apnea

NCT00753077

Sleep Apnea, Obstructive

COMPLETED

SLEEPINESS - a Search for a Biomarker of Excessive Daytime Sleepiness in Severe Obstructive Sleep Apnoea - An Explorative Study

NCT06711159

Obstructive Sleep Apnea (OSA) Excessive Daytime Sleepiness

RECRUITING

Influence of Craniofacial Restriction on Rebound of Obstructive Sleep Apnea Following Weight Gain

NCT03051815

Observation

COMPLETED

3D Volumetric Changes in the Upper Airway After MMA in OSAS Patients and the Implication on QOL: A Prospective Registry

NCT02762175

Obstructive Sleep Apnea

RECRUITING

Investigation of Respiratory Functions, Respiratory Muscle Strength, Balance and Sleep Quality in Patients With Bruxism

NCT07294833

Bruxism Respiratory Function Sleep Quality +1 more

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

OSA

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

OTHER

Study Time Perspective

OTHER

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Test group SAHOS

The 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

CBCT

Intervention Type OTHER

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

Control group no SAHOS

Concerning 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).

CBCT

Intervention Type OTHER

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

CBCT

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

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* (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.

Exclusion Criteria

* (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).

Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes