RCMP Prediction for Sleep Apnea Surgery Success

Overseen By Jennifer Lay-Luskin

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Michigan

Must not be taking: Opioids

Disqualifiers: BMI ≥ 35, Pregnancy, CSA, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 5

20 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to identify which patients are most likely to benefit from maxillomandibular advancement (MMA) surgery for obstructive sleep apnea (OSA), a condition where breathing stops and starts during sleep. The researchers will use a special device to predict surgery success by testing how jaw adjustments affect sleep. They seek participants with moderate to severe OSA, who struggle with using breathing machines, and have a BMI between 25 and 34.9. The goal is to better match patients with effective treatments. As an unphased trial, this study offers a unique opportunity to contribute to research that could lead to more personalized and effective treatments for OSA.

Will I have to stop taking my current medications?

The trial protocol does not specify whether you need to stop taking your current medications. However, if you are using chronic opioids, you would not be eligible to participate.

What prior data suggests that the RCMP device is safe for identifying candidates for MMA surgery?

Research shows that maxillomandibular advancement (MMA) surgery effectively treats moderate to severe obstructive sleep apnea (OSA). However, some patients may experience changes in facial appearance or jaw alignment issues post-surgery.

Studies have found that a device called a remotely controlled mandibular positioner (RCMP) can predict which patients will benefit most from certain sleep apnea treatments. This device identifies the optimal jaw position to enhance sleep quality. The RCMP determines how much the jaw should move forward for successful oral appliance therapy and helps customize treatments for those considering MMA surgery.

While detailed safety data specifically for using the RCMP to predict MMA outcomes is lacking, the device is generally used in a controlled and monitored setting, suggesting it is safe for these purposes. In summary, MMA surgery is a common treatment for sleep apnea, and the RCMP device enhances the precision of treatment plans. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the trial for the Remotely Controlled Mandibular Positioner (RCMP) because it offers a new approach to predicting the success of surgery for sleep apnea. Unlike static evaluations, this method allows for dynamic titration of the jaw position, potentially leading to more personalized and effective surgical outcomes. This innovative technique could help identify which patients are most likely to benefit from surgery, thereby improving treatment success rates and minimizing unnecessary procedures.

What evidence suggests that the RCMP device is effective for predicting success in MMA surgery for OSA?

Research has shown that maxillomandibular advancement (MMA) surgery ranks among the most effective treatments for obstructive sleep apnea (OSA). Studies indicate that this surgery significantly reduces the apnea-hypopnea index (AHI), a measure of sleep apnea severity. In many cases, more than half of the patients achieve complete relief from severe OSA. Compared to other surgeries, MMA has a higher success rate, and most side effects are temporary. Additionally, MMA combined with soft tissue surgery proves more effective than soft tissue surgery alone for treating OSA. These findings suggest that MMA is a strong option for those with moderate to severe OSA.

In this trial, participants will undergo RCMP titration, using a Remotely Controlled Mandibular Positioner, to predict the success of sleep apnea surgery. ^{6 7 8 9 10}

Who Is on the Research Team?

Sharon Aronovich, DMD

Principal Investigator

University of Michigan

Are You a Good Fit for This Trial?

This trial is for people aged 30-65 with moderate to severe obstructive sleep apnea (OSA), who have an AHI of at least 15/hour and a BMI between 25-34.9. They should be good candidates for surgery but unable or unwilling to use PAP therapy. Those with a high BMI, central sleep apnea, opioid use, TMJ disorders, dental issues, pregnancy, or inability to follow-up post-surgery are excluded.

Inclusion Criteria

You have a body mass index (BMI) between 25 and 34.9.

I cannot or do not want to use a PAP machine.

I am considered a good candidate for surgery.

Exclusion Criteria

I am either under 30 or over 65 years old.

I cannot attend follow-up visits after surgery.

You have been diagnosed with central sleep apnea based on a sleep test.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

RCMP Titration Study

Participants undergo a titration study using a remote controlled mandibular positioner to evaluate changes in polysomnographic parameters with mandibular protrusion

1-2 weeks

1 visit (in-person)

MMA Surgery

Participants undergo maxillomandibular advancement surgery with a standard 10 mm advancement of the upper and lower jaw

1 week

1 visit (in-person)

Follow-up

Participants have a follow-up polysomnogram four to eight months post-operatively to assess for treatment response

4-8 months

2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Maxillomandibular Advancement Surgery
• RCMP

Trial Overview The study tests if a remote controlled mandibular positioner (RCMP) can predict the success of maxillomandibular advancement (MMA) surgery in treating OSA. It aims to see if RCMP titration helps customize treatment by determining the necessary degree of jaw protrusion before surgery.

How Is the Trial Designed?

Group I: RCMP titration Experimental Treatment 1 Intervention

Remotely Controlled Mandibular Positioner

Maxillomandibular Advancement Surgery is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Maxillomandibular Advancement Surgery for:

• Obstructive Sleep Apnea (OSA)

Approved in European Union as Maxillomandibular Advancement Surgery for:

• Obstructive Sleep Apnea (OSA)

Approved in Canada as Maxillomandibular Advancement Surgery for:

• Obstructive Sleep Apnea (OSA)

Who Is Running the Clinical Trial?

University of Michigan

Lead Sponsor

Trials

1,891

Recruited

6,458,000+

Published Research Related to This Trial

Maxillary, mandibular, and chin advancement (MMCA) surgery was effective in treating obstructive sleep apnea in 20 adult patients who had not responded to other treatments, showing improvements in the Respiratory Disturbance Index (RDI), blood oxygen saturation, and sleepiness levels.

The study found a significant relationship between changes in the posterior airway space (PAS) and reductions in RDI, indicating that the surgery positively impacts airway dimensions, which is crucial for alleviating sleep apnea symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Maxillary, mandibular and chin advancement surgery for the treatment of obstructive sleep apnoea. Jones, R., Badlani, J., Jones, C.[2013]

Mandibular advancement surgery significantly improved respiratory parameters, such as the respiratory disturbance index and oxygen desaturation index, in patients after an average of 9.5 months post-operation.

In contrast, surgeries involving mandibular setback and maxillary advancement led to a deterioration in respiratory parameters, suggesting that these procedures may increase upper airway resistance and potentially cause obstructive sleep apnea.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The influence of orthognathic surgery on ventilation during sleep. Foltán, R., Hoffmannová, J., Pavlíková, G., et al.[2022]

Maxillomandibular advancement (MMA) significantly reduces the apnea-hypopnea index (AHI) in patients with moderate to severe obstructive sleep apnea (OSA), with a decrease from a mean of 49 to 10.9 events per hour over an average follow-up of 6.6 years.

MMA also leads to improvements in blood pressure, sleepiness, and quality of life, with few long-term adverse events, making it a safe and effective alternative for patients who struggle with CPAP therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-Term Effectiveness and Safety of Maxillomandibular Advancement for Treatment of Obstructive Sleep Apnea. Boyd, SB., Walters, AS., Waite, P., et al.[2018]

In a study of 195 patients undergoing bimaxillary orthognathic surgery, factors such as premedication with benzodiazepines, being male, and longer surgery duration were identified as independent risk factors for prolonged mechanical ventilation and delayed extubation.

Conversely, using total intravenous anesthesia was linked to shorter ventilation times, suggesting that anesthesia type may play a crucial role in postoperative recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Risk Factors for Prolonged Mechanical Ventilation and Delayed Extubation Following Bimaxillary Orthognathic Surgery: A Single-Center Retrospective Cohort Study. Schwer, CI., Roth, T., Gass, M., et al.[2022]

Bimaxillary advancement surgery significantly increases upper airway size in patients with obstructive sleep apnea, which can help alleviate symptoms of the condition.

The surgery also leads to improved oximetric indicators (like AHI and O2 saturation) and enhances quality of life, as measured by the Epworth sleepiness scale, based on a systematic review of 26 articles and a meta-analysis of 23 studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of Bimaxillary Advancement Surgery on the Upper Airway and on Obstructive Sleep Apnea Syndrome: a Meta-Analysis. Rojo-Sanchis, C., Almerich-Silla, JM., Paredes-Gallardo, V., et al.[2019]

Bimaxillary orthognathic surgery with maxillomandibular setback significantly reduces the oropharyngeal airway volume by 29%, indicating a notable change in airway space post-surgery.

Despite the reduction in airway space, the surgery did not significantly affect the Apnea-Hypopnea Index (AHI) values, suggesting that it does not induce obstructive sleep apnea in patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Three-dimensional analysis of changes in airway space after bimaxillary orthognathic surgery with maxillomandibular setback and their association with obstructive sleep apnea. Jang, SI., Ahn, J., Paeng, JY., et al.[2022]

In a study of 50 patients undergoing maxillomandibular advancement for obstructive sleep apnea, the preoperative Mallampati scores did not significantly predict surgical outcomes, as both high and low score groups showed similar improvements in apnea/hypopnea indices post-surgery.

The results suggest that while the Mallampati classification can help in selecting patients for certain procedures, it is not a reliable predictor of success for maxillomandibular advancement surgery in treating obstructive sleep apnea.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Does a patient's Mallampati score predict outcome after maxillomandibular advancement for obstructive sleep apnoea? Islam, S., Selbong, U., Taylor, CJ., et al.[2014]

In a study of 59 patients with severe obstructive sleep apnea, maxillomandibular advancement surgery showed no serious postoperative complications, although some patients experienced local issues like mental nerve sensory loss and cosmetic changes.

The surgery significantly improved sleep apnea severity, with the apnea-hypopnea index decreasing from an average of 65.5 to 14.4 events per hour, indicating a successful surgical response and improved sleep quality.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Complications/adverse effects of maxillomandibular advancement for the treatment of OSA in regard to outcome. Blumen, MB., Buchet, I., Meulien, P., et al.[2009]

Maxillomandibular advancement surgery can effectively eliminate obstructive apneas and hypopneas in patients with obstructive sleep apnea, as demonstrated in a study of 24 patients, requiring at least a 10 mm advancement of the maxilla and mandible for successful outcomes.

This surgical option should be reserved for patients with specific craniofacial disorders, and other factors like obesity should be addressed first, as non-invasive treatments like nCPAP therapy are effective alternatives.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Surgical treatment of obstructive sleep apnea by osteotomy of the facial bones (results of 1 year)]. Hochban, W., Brandenburg, U., Peter, JH.[2009]

A patient who underwent maxillomandibular advancement surgery for obstructive sleep apnea experienced total airway obstruction immediately after extubation, highlighting a potential risk associated with this surgical procedure.

The case emphasizes the importance of performing nasopharyngolaryngoscopy before extubation to check for complications like pharyngeal edema and hematoma, which can lead to life-threatening airway issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Total airway obstruction after maxillomandibular advancement surgery for obstructive sleep apnea. Hogan, PW., Argalious, M.[2007]

In a study involving 10 Chinese adults with severe obstructive sleep apnea (OSA), counterclockwise maxillomandibular advancement (MMA) combined with quantified uvulopalatopharyngoplasty (UPPP) resulted in a significant reduction in the apnea-hypopnea index (AHI) from 64.3 to 11.0 per hour, achieving a surgical success rate of 90%.

The procedures not only improved airway dimensions and oxygen saturation but also maintained aesthetic outcomes without causing visual abnormalities, suggesting that this combined surgical approach could be beneficial for patients with severe OSA, particularly those with a convex facial profile.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Combined Counterclockwise Maxillomandibular Advancement and Uvulopalatopharyngoplasty Surgeries for Severe Obstructive Sleep Apnea. Yu, W., Wang, M., He, J., et al.[2019]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39764681/

Maxillomandibular Advancement Safety and Effectiveness ... Maxillomandibular advancement has the highest success rate for obstructive sleep apnea among current surgical treatments, with most sequelae being transient.

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S2468785524003471

Effectiveness of orthognathic surgery by maxillomandibular ... Compared with soft tissue surgery alone, orthognathic surgery combined with soft tissue surgery is more effective as curative treatment for OSA syndrome.

3. jcsm.aasm.org jcsm.aasm.org/doi/10.5664/jcsm.4838

Long-Term Effectiveness and Safety of Maxillomandibular ... MMA is a clinically effective and safe long-term treatment for most patients with moderate-to-severe OSA as demonstrated by significant decreases in AHI, ...

4. mayoclinic.org mayoclinic.org/medical-professionals/pulmonary-medicine/news/maxillomandibular-advancement-surgery-a-classic-procedure-refined/mac-20430404

Maxillomandibular advancement surgery: A classic ... At Mayo Clinic, the vast majority of patients, even those with severe OSA, have a successful outcome. In fact, more than half of patients achieve elimination of ...

5. mdpi.com mdpi.com/2076-3417/15/16/9149

Maxillomandibular Advancement (MMA) Surgery Improves ... The aim of this study was to compare CAD/CAM-assisted maxillomandibular advancement (MMA) with traditional surgical techniques in the treatment of obstructive ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3773201/

Remotely Controlled Mandibular Protrusion during Sleep ... Remotely controlled mandibular protrusion during sleep predicts therapeutic success with oral appliances in patients with obstructive sleep apnea. SLEEP 2013;36 ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5033744/

The Use of Remotely Controlled Mandibular Positioner as a ... RCMP might be a promising instrument for predicting OAm treatment outcome and targeting the degree of mandibular advancement needed.

8. jcsm.aasm.org jcsm.aasm.org/doi/10.5664/jcsm.6656

A Feedback-Controlled Mandibular Positioner Identifies ... A feedback-controlled mandibular positioner identifies individuals with sleep apnea who will respond to oral appliance therapy. J Clin Sleep Med. 2017;13(7):871 ...

9. clinicaltrials.gov clinicaltrials.gov/study/NCT03929549

Preliminary Evaluation of a RCMP to Predict Failure ... This study will be done to determine predictors of success with MMA surgery in patients with moderate to severe OSA. Studies have already shown the value of a ...

10. frontiersin.org frontiersin.org/journals/sleep/articles/10.3389/frsle.2023.1144327/pdf

Innovations in mandibular advancement splint therapy for ... This paper reviews these current and emerging innovations in MAS therapy and their impact upon sleep apnoea management. KEYWORDS oral appliance, ...