NCT06022679

Brief 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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
46

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Apr 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2022

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2023

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

August 16, 2023

Completed
20 days until next milestone

First Posted

Study publicly available on registry

September 5, 2023

Completed
Last Updated

September 5, 2023

Status Verified

August 1, 2023

Enrollment Period

1 year

First QC Date

August 16, 2023

Last Update Submit

August 31, 2023

Conditions

Keywords

Young no-overweight adultOSAcephalometry3D

Outcome Measures

Primary Outcomes (1)

  • maxillary volume

    maxillary volume with 3D cephalométric analysis

    2month

Study Arms (2)

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

Other: 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).

Other: CBCT

Interventions

CBCTOTHER

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

Control group no SAHOSTest group SAHOS

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
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).

You may qualify if:

  • (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.

You may not qualify if:

  • (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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Liège, site Brull

Liège, 4020, Belgium

Location

Related Publications (1)

  • 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.

Study Officials

  • Annick AB Bruwier

    Service d'orthopédie dento-faciale CHU Liège

    STUDY DIRECTOR
  • mathilde jadoul

    Service Orthopédie dento-faciale CHU Liege

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
post graduated dento facial orthopedic department

Study Record Dates

First Submitted

August 16, 2023

First Posted

September 5, 2023

Study Start

April 1, 2022

Primary Completion

April 1, 2023

Study Completion

April 1, 2023

Last Updated

September 5, 2023

Record last verified: 2023-08

Locations