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Clinical Trials in Belgium / NCT02762175
Recruiting Observational

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

NCT02762175 · tracked via the Priya Life Science Belgium tracker
Sponsor
AZ Sint-Jan AV
Phase
Observational
Started
2015-01
Last updated
2022-02-28

Condition(s) studied

Obstructive Sleep Apnea

Study summary

Background

Obstructive sleep apnea syndrome (OSAS) is a sleep-related breathing disorder characterized by intense snoring and repetitive complete or partial obstructions of the upper airway during sleep together with daytime sleepiness. Several non-invasive therapeutical options exist, however, they do not offer a permanent improvement. Maxillomandibular advancement (MMA) surgery is a procedure which changes the upper airway in a permanent way.

Objectives

The investigators aim to develop a prospective database registering 3D volumetric changes of the upper airway and its anatomic subregions, the apnea-hypopnea index (AHI) and quality of life (QOL) of all consecutive patients eligible for MMA, performed by Dr. Neyt. Patient demographics, detailed virtual cone-beam computed tomography (CBCT) planning parameters, orthognathic surgery, polysomnographic and QOL data are being collected during consecutive visits within the framework of routine practice.

Design

A prospective, observational cohort study

Study center

General Hospital (AZ) Sint-Jan Brugge-Oostende

Population

The investigators would like to include all OSAS patients (AHI ≥ 5) requiring a MMA by Dr. Neyt starting from January 2015.

Endpoints

The investigators aim to collect data that could provide information about the advantages and disadvantages of the routinely performed 3D CBCT preoperative MMA surgery planning for OSAS patients, regarding 3D volumetric changes of the upper airway and its anatomic subregions and quality of life (QOL) in a subjective manner with the Epworth Sleepiness Scale (ESS) and the OSAS questionnaire and in an objective manner with evaluation of the apnea-hypopnea index (AHI).

Duration

In light of the continuous improvement of patient care, a database will be maintained from January 2015 onwards to enable registration of large-scale OSAS patient data.

Conclusions

Development of a database registering 3D CBCT planning, polysomnographic data and quality of life (QOL) of all consecutive patients eligible for MMA, will provide more information about potential patient, virtual planning and surgical factors influencing accuracy of MMA, and the associated biological benefits of this procedure on the upper airway volume, the AHI and general QOL. Moreover, registration of those results could function as a measurement of quality of care, or could be used for sample size calculation for future large multicenter prospective trials.

Eligibility

Sex
ALL
Min age
—
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Patients of all ages * Patients of all genders * Patients diagnosed with OSAS, based on an AHI ≥ 5 * All consecutive OSAS patients operated by N. Neyt from January 2015 onwards Exclusion Criteria: * Patients not eligible according to abovementioned criteria * Patients with morbid obesity (BMI \>35), if judged non-eligible by the treating surgeon

Primary outcome measure(s)

  • postoperative apnea-hypopnea index, measured with polysomnography — 6-12 months

Trial sites (1)

FacilityCityRegionStatus
Division of Maxillofacial Surgery, Department of Surgery, AZ Sint-Jan Brugge Oostende AV Bruges Belgium Recruiting

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Other trials for the same condition

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A Post-market Clinical Follow up of the Genio® System for the Treatment of Obstructive Sleep Apnea in Adults Active, not recruiting
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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT02762175 on ClinicalTrials.gov ↗ ← All trials in Belgium