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

Obstructive Sleep Apnea Clinical Trial

— MMA-OSAS  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02762175
• Other study ID #: B049201627590
• Status: Recruiting
• Start date: January 2015
• Est. completion date: June 2030

Study information

• Verified date: February 2022
• Source: AZ Sint-Jan AV
• Contact: Araceli Diez-Fraile, MSc, PhD, VMD
• Email: araceli.diez-fraile[@]azsintjan.be
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: June 2030
• Est. primary completion date: January 2030
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Apnea
• Obstructive Sleep Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Locations

Country	Name	City	State
Belgium	Division of Maxillofacial Surgery, Department of Surgery, AZ Sint-Jan Brugge Oostende AV	Bruges

Sponsors (1)

Lead Sponsor	Collaborator
AZ Sint-Jan AV

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	postoperative apnea-hypopnea index, measured with polysomnography		6-12 months
Secondary	3D volumetric changes of the upper airway, measured with cone-beam CT		4-6 months
Secondary	quality of life, measured with epworth sleepiness scale		4-12 months
Secondary	quality of life, measured with OSAS questionnaire		4-12 months