跳至主要内容
临床试验/NCT03929549
NCT03929549招募中不适用

Preliminary Evaluation of a Remotely Controlled Mandibular Positioner to Predict Failure of Maxillomandibular Advancement Surgery for Obstructive Sleep Apnea

University of Michigan2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2019年8月12日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
20
试验地点
2
主要终点
Primary outcome variable: Change in AHI (pre-post) with MMA surgery

研究概览

简要总结

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.

详细描述

The use of a remotely controlled mandibular protrusion (RCMP) device allows for customization of treatment by titrating the extent of mandibular protrusion during a polysomnogram. Use of the RCMP device has a high degree of positive and negative predictive value in determining the effectiveness and degree (effective target protrusive position) of mandibular advancement need with oral appliance therapy (Remmers, 2013). Preliminary data from 4 patients (Hoekena 2006) indicates that patients with a significant response to oral appliance therapy (>50% reduction in AHI) may have a better response to MMA. This study will determine the efficacy of MMA in patients with moderate to severe OSA, and determine if the RCMP titration can predict success or failure with MMA for treatment of OSA.

Patients will undergo detailed history and physical examination by Oral & Maxillofacial Surgery. Those patients found to be potential candidates for jaw advancement (MMA) surgery will be recruited to enroll in the study. Once consented and enrolled, study participants will undergo a titration study using a remote controlled mandibular positioner (RCMP titration study) to evaluate changes in polysomnographic parameters (i.e. Apnea-hypopnea index and oxygen saturation) with mandibular protrusion. Patients will then undergo maxillomandibular advancement surgery (MMA surgery). During MMA surgery, a standard 10 mm advancement of the upper and lower jaw is performed. Slight modifications may be made to the degree of advancement in order to achieve acceptable facial esthetics. Data from the RCMP titration study will not affect how the MMA surgery is performed. After surgery, participants will have a follow-up polysomnogram four to eight months post-operatively to assess for treatment response and compared this to the predicted response based on the RCMP titration study.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Other
盲法
None

入排标准

年龄范围
30 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • AHI ≥ 15/hour
  • 30-65 years of age
  • BMI 25-34.9
  • Ideal operative candidate
  • Unable or unwilling to use PAP

排除标准

  • younger than 30 or older than 65 years of age
  • 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

结局指标

主要结局

Primary outcome variable: Change in AHI (pre-post) with MMA surgery

时间窗: baseline (pre-operative), post surgery (6 months)

Secondary outcome variable: Failure of MMA surgery defined as AHI ≥ 15/hour

Primary predictor variable: Change in AHI, from baseline to maximal therapeutic protrusion, with RCMP study

时间窗: baseline (pre-operative), post surgery (6 months)

age, sex, BMI, AHI, retrognathia, airway collapse on forced inspiration, AHI reduction on RCMP titration and magnitude of advancement.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Sharon Aronovich

Clinical Assistant Professor of Dentistry, Department of Oral and Maxillofacial Surgery, School of Dentistry and Assistant Professor of Oral Surgery

University of Michigan

研究点 (2)

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