Evaluating a device to predict success of jaw surgery for sleep apnea
Preliminary Evaluation of a Remotely Controlled Mandibular Positioner to Predict Failure of Maxillomandibular Advancement Surgery for Obstructive Sleep Apnea
This study is testing a new device to see if it can help predict how well jaw surgery will work for people with moderate to severe sleep apnea.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 30 Years to 65 Years |
| Sex | All |
| Sponsor | University of Michigan Academic / other |
| Locations | 1 site (Ann Arbor, Michigan) |
| Trial ID | NCT03929549 on ClinicalTrials.gov |
What this trial studies
This study aims to identify predictors of success for maxillomandibular advancement (MMA) surgery in patients with moderate to severe obstructive sleep apnea (OSA). It utilizes a remote controlled mandibular positioner (RCMP) to customize treatment by assessing the optimal level of mandibular protrusion during a titration study. Participants will undergo a detailed evaluation and, if deemed suitable, will have MMA surgery after the RCMP titration. The goal is to determine if the RCMP can effectively predict surgical outcomes for OSA patients.
Who should consider this trial
Good fit: Ideal candidates are adults aged 30-65 with moderate to severe OSA who are unable or unwilling to use positive airway pressure (PAP) therapy.
Not a fit: Patients with a BMI of 35 or higher, those under 30 or over 65 years old, or individuals with central sleep apnea may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to more personalized and effective treatment options for patients with obstructive sleep apnea.
How similar studies have performed: Preliminary data from previous studies suggest that similar approaches using mandibular advancement techniques have shown promise, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: AHI ≥ 15/hour 30-65 years of age BMI 25-34.9 Ideal operative candidate Unable or unwilling to use PAP Exclusion Criteria: BMI ≥ 35 younger than 30 or older than 65 years of age pregnancy Central sleep apnea (CSA) on baseline polysomnogram Chronic opioid use Active TMJ Disorders Inability to protrude the mandible beyond 5 mm Inability to follow-up after surgery Dental disorders including loose teeth or advanced periodontal disease
Where this trial is running
Ann Arbor, Michigan
- Michigan Medicine Oral and Maxillofacial Surgery — Ann Arbor, Michigan, United States (Recruiting)
Study contacts
- Principal investigator: Sharon Aronovich, DMD — University of Michigan
- Study coordinator: Jennifer Lay-Luskin
- Email: jalay@med.umich.edu
- Phone: 734-763-5963
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.