NCT02762175 3D Volumetric Changes in the Upper Airway After MMA in OSAS Patients and the Implication on QOL: A Prospective Registry
| NCT ID | NCT02762175 |
| Status | Recruiting |
| Phase | — |
| Sponsor | AZ Sint-Jan AV |
| Condition | Obstructive Sleep Apnea |
| Study Type | OBSERVATIONAL |
| Enrollment | 150 participants |
| Start Date | 2015-01 |
| Primary Completion | 2030-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 150 participants in total. It began in 2015-01 with a primary completion date of 2030-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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
Contact & Investigator
Araceli Diez-Fraile, MSc, PhD, VMD
✉ araceli.diez-fraile@azsintjan.beNathalie Neyt, MD
PRINCIPAL INVESTIGATOR
Division of Maxillofacial Surgery, Department of Surgery, AZ Sint-Jan Brugge-Oostende AV
Frequently Asked Questions
Who can join the NCT02762175 clinical trial?
This trial is open to participants of all sexes, studying Obstructive Sleep Apnea. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT02762175 currently recruiting?
Yes, NCT02762175 is actively recruiting participants. Contact the research team at araceli.diez-fraile@azsintjan.be for enrollment information.
Where is the NCT02762175 trial being conducted?
This trial is being conducted at Bruges, Belgium.
Who is sponsoring the NCT02762175 clinical trial?
NCT02762175 is sponsored by AZ Sint-Jan AV. The principal investigator is Nathalie Neyt, MD at Division of Maxillofacial Surgery, Department of Surgery, AZ Sint-Jan Brugge-Oostende AV. The trial plans to enroll 150 participants.