Maxillomandibular advancement for treating obstructive sleep apnea
Impact of Maxillomandibular Advancement Upon the Pharyngeal Airway Volume and the Apnea-hypopnea Index in the Treatment of Obstructive Sleep Apnea
This study tests if maxillomandibular advancement surgery can improve sleep apnea symptoms and airway size in people with obstructive sleep apnea over time.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Centro Medico Teknon Academic / other |
| Drugs / interventions | Denosumab, chemotherapy |
| Locations | 1 site (Barcelona) |
| Trial ID | NCT03796078 on ClinicalTrials.gov |
What this trial studies
This study investigates the effects of maxillomandibular advancement surgery on patients with obstructive sleep apnea (OSA). It aims to correlate changes in pharyngeal airway volume with clinical indicators of OSA, such as the apnea-hypopnea index and the Epworth Sleepiness Scale. The study involves a multidisciplinary team and includes assessments before surgery, one month post-surgery, and twelve months post-surgery to evaluate the stability of airway volume and clinical outcomes. Participants will undergo polysomnography to monitor their sleep apnea severity throughout the study.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 with dentofacial deformities who are suitable for orthognathic surgery.
Not a fit: Patients with contraindications for surgery or those with facial syndromic malformations may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve the management of obstructive sleep apnea and enhance patients' quality of life.
How similar studies have performed: Previous studies have shown promising results with surgical interventions for obstructive sleep apnea, indicating potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Patients over 18 years of age who present any kind of dentofacial deformity candidates for orthognathic surgery treatment. 2. Growth of the maxillofacial complex completed. 3. Patients without uncontrolled cardio-pulmonary disease. 4. Patients willing to understand the procedures of the study and that agree to give their signed informed consent. 5. Patients who commit to perform the postoperative controls for at least one postoperative year. 6. Patients with a good general condition of health, confirmed by pre-operative study and assessment by Anaesthesiology (ASA). Exclusion Criteria: 1. Patients with a clinical history in which any surgery would be contraindicated 2. Patients with any facial Syndromic malformation 3. Patients who have undergone chemotherapy or radiotherapy during the last 5 years, including area of head and neck. 4. Patients who refuse to accept the clinical conditions of the study and are not willing to sign the form corresponding informed consent. 5. Patients who are expected to lack adherence to follow-up or to the treatment. 6. Treatment with bisphosphonates or Denosumab (Prolia®).
Where this trial is running
Barcelona
- Institute of Maxillofacial Surgery, Teknon Medical Center — Barcelona, Spain (Recruiting)
Study contacts
- Principal investigator: Adaia Valls-Ontañón, PhD — Institute of Maxillofacial Surgery, Teknon Medical Center
- Study coordinator: Maria Giralt-Hernando, PhD
- Email: mgiralt@uic.es
- Phone: +34933 933 185
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.