Clinical trial NCT02762175: 3D Volumetric Changes in the Upper Airway After MMA in OSAS Patients and the Implication on QOL: A Prospective Registry
Official title: 3D Volumetric Changes in the Upper Airway After Maxillomandibular Advancement in Obstructive Sleep Apnea Syndrome Patients and the Implication on Quality of Life: A Prospective Registry
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Obstructive Sleep Apnea
Keywords: maxillomandibular advancement
obstructive sleep apnea
apnea-hypopnea index
quality of life
Lead sponsor: AZ Sint-Jan AV
Sponsor class: OTHER
First posted: 2016-05-04
Enrollment: 150
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: all OSAS patients (AHI ≥ 5) requiring a MMA by Dr. Neyt starting from January 2015

Brief 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 criteria: 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 outcomes:
measure: postoperative apnea-hypopnea index, measured with polysomnography
timeFrame: 6-12 months
Secondary outcomes:
measure: 3D volumetric changes of the upper airway, measured with cone-beam CT
timeFrame: 4-6 months
measure: quality of life, measured with epworth sleepiness scale
timeFrame: 4-12 months
measure: quality of life, measured with OSAS questionnaire
timeFrame: 4-12 months
Other outcomes:
Locations:
city: Bruges
country: Belgium
facility: Division of Maxillofacial Surgery, Department of Surgery, AZ Sint-Jan Brugge Oostende AV
Study officials:
affiliation: Division of Maxillofacial Surgery, Department of Surgery, AZ Sint-Jan Brugge-Oostende AV
name: Nathalie Neyt, MD
role: PRINCIPAL_INVESTIGATOR
References: