3D changes in the upper airway after surgery for sleep apnea
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
This study is looking at how surgery for sleep apnea changes the shape of the upper airway in patients to see how it affects their breathing and quality of life.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 150 (estimated) |
| Sex | All |
| Sponsor | AZ Sint-Jan AV Academic / other |
| Locations | 1 site (Bruges) |
| Trial ID | NCT02762175 on ClinicalTrials.gov |
What this trial studies
This observational study aims to create a prospective database that tracks 3D volumetric changes in the upper airway of patients diagnosed with obstructive sleep apnea (OSAS) who undergo maxillomandibular advancement (MMA) surgery. The study will collect data on the apnea-hypopnea index (AHI) and quality of life (QOL) from patients treated by Dr. Neyt since January 2015. By analyzing these changes, the researchers hope to better understand the implications of MMA surgery on patient outcomes and airway anatomy.
Who should consider this trial
Good fit: Ideal candidates for this study are patients of all ages and genders diagnosed with obstructive sleep apnea, specifically those with an apnea-hypopnea index of 5 or greater.
Not a fit: Patients with morbid obesity or those deemed non-eligible by the treating surgeon will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the effectiveness of MMA surgery in improving airway structure and patient quality of life.
How similar studies have performed: While there have been studies on MMA surgery for OSAS, this specific approach focusing on 3D volumetric changes and quality of life is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Bruges
- Division of Maxillofacial Surgery, Department of Surgery, AZ Sint-Jan Brugge Oostende AV — Bruges, Belgium (Recruiting)
Study contacts
- Principal investigator: Nathalie Neyt, MD — Division of Maxillofacial Surgery, Department of Surgery, AZ Sint-Jan Brugge-Oostende AV
- Study coordinator: Araceli Diez-Fraile, MSc, PhD, VMD
- Email: araceli.diez-fraile@azsintjan.be
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.