Actively Recruiting
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
Led by AZ Sint-Jan AV · Updated on 2022-02-28
150
Participants Needed
1
Research Sites
21 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying obstructive sleep apnea syndrome (OSAS), a sleep disorder marked by loud snoring and repeated airway blockages during sleep that cause daytime tiredness. This observational study aims to create a prospective database to track changes in the upper airway volume and anatomy after maxillomandibular advancement (MMA) surgery, along with measuring the apnea-hypopnea index (AHI) and patients' quality of life. The study collects detailed data on patient demographics, virtual 3D cone-beam CT (CBCT) surgical planning, orthognathic surgery details, sleep study results, and quality of life assessments as part of routine care.
CONDITIONS
Brief Title
3D Volumetric Changes in the Upper Airway After MMA in OSAS Patients and the Implication on QOL: A Prospective Registry
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients of all ages
- Patients of all genders
- Patients diagnosed with OSAS, based on an AHI 25 5
- All consecutive OSAS patients operated by N. Neyt from January 2015 onwards
You will not qualify if you...
- Patients not eligible according to abovementioned criteria
- Patients with morbid obesity (BMI >35), if judged non-eligible by the treating surgeon
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 1 week
Participants undergo maxillomandibular advancement surgery and receive immediate post-operative care.
1 hospital stay with immediate post-operative monitoring
Duration - 4 to 12 months
Participants are monitored to assess 3D volumetric changes of the upper airway and quality of life after surgery.
Multiple visits including imaging and questionnaire assessments over 4 to 12 months
Trial Site Locations
Total: 1 location
1
Division of Maxillofacial Surgery, Department of Surgery, AZ Sint-Jan Brugge Oostende AV
Bruges, Belgium
Actively Recruiting
Research Team
A
Araceli Diez-Fraile, MSc, PhD, VMD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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