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

Trial Summary

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 data supports the effectiveness of the treatment Maxillomandibular Advancement Surgery for sleep apnea?

Research shows that bimaxillary advancement surgery, which is similar to maxillomandibular advancement, increases the size of the upper airway and improves measures like oxygen levels and sleepiness in people with obstructive sleep apnea. Another study found that maxillomandibular advancement surgery significantly reduced the severity of sleep apnea, as measured by the apnea/hypopnea index, regardless of the patient's initial airway classification. ^{1 2 3 4 5}

Is maxillomandibular advancement surgery safe for humans?

Maxillomandibular advancement surgery is generally considered safe, but it can have complications like airway issues after surgery. It's important to have proper monitoring and follow-up care to manage these risks. ^{4 5 6 7 8}

How does maxillomandibular advancement surgery differ from other treatments for sleep apnea?

Maxillomandibular advancement surgery is unique because it physically moves the upper and lower jaws forward to enlarge the airway, which can significantly reduce sleep apnea symptoms, especially for those who cannot tolerate other treatments like CPAP (continuous positive airway pressure). This surgery is particularly effective for patients with certain facial structures and can lead to long-term improvements in breathing during sleep. ^{1 2 9 10 11}

What is the purpose of this trial?

Maxillomandibular advancement (MMA) surgery, one of the most successful surgical procedures for the treatment of obstructive sleep apnea (OSA), is predominantly used to manage patients with moderate to severe OSA. However, limiting factors include incomplete response in some cases, unfavorable facial changes as a result of large advancements, and risk of malocclusion or malunion. 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 remote controlled mandibular positioner (RCMP) device to identify the correct level of therapeutic protrusion needed with oral appliance therapy. Moreover, some patients experience a dose dependent improvement in sleep parameters based on the degree of protrusion during the titration study. Use of RCMP as a means to identify potential candidates for MMA, may help customize treatment options for patients with OSA by providing predictive value.

Research Team

Sharon Aronovich, DMD

Principal Investigator

University of Michigan

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Impact of Bimaxillary Advancement Surgery on the Upper Airway and on Obstructive Sleep Apnea Syndrome: a Meta-Analysis. [2019]

2. Scotland pubmed.ncbi.nlm.nih.gov

Does a patient's Mallampati score predict outcome after maxillomandibular advancement for obstructive sleep apnoea? [2014]

3. Australia pubmed.ncbi.nlm.nih.gov

Maxillary, mandibular and chin advancement surgery for the treatment of obstructive sleep apnoea. [2013]

4. England pubmed.ncbi.nlm.nih.gov

Complications/adverse effects of maxillomandibular advancement for the treatment of OSA in regard to outcome. [2009]

5. England 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. [2022]

6. Denmark pubmed.ncbi.nlm.nih.gov

The influence of orthognathic surgery on ventilation during sleep. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Long-Term Effectiveness and Safety of Maxillomandibular Advancement for Treatment of Obstructive Sleep Apnea. [2018]

8. Switzerland pubmed.ncbi.nlm.nih.gov

Risk Factors for Prolonged Mechanical Ventilation and Delayed Extubation Following Bimaxillary Orthognathic Surgery: A Single-Center Retrospective Cohort Study. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

Combined Counterclockwise Maxillomandibular Advancement and Uvulopalatopharyngoplasty Surgeries for Severe Obstructive Sleep Apnea. [2019]

10. Germany pubmed.ncbi.nlm.nih.gov

[Surgical treatment of obstructive sleep apnea by osteotomy of the facial bones (results of 1 year)]. [2009]

11. United States pubmed.ncbi.nlm.nih.gov

Total airway obstruction after maxillomandibular advancement surgery for obstructive sleep apnea. [2007]