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临床试验/NCT02805764
NCT02805764撤回不适用

Changes in Upper Airway Anatomy, Quality of Life Measures, and Polysomnographic Parameters Using A Functional Dental Appliance

Montefiore Medical Center2 个研究点 分布在 1 个国家开始时间: 2018年4月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
撤回
试验地点
2
主要终点
Polysomnographic (PSG) parameters, mainly AHI and O2 desaturation measures

研究概览

简要总结

A prospective study measuring changes in upper airway anatomy, quality of life measures, and polysomnographic parameters using a functional dental appliance (Homeoblock)

详细描述

Although rising levels of obesity heavily influences the increasing rates of obstructive sleep apnea (OSA), detailed analysis of more basic etiology suggests a possible craniofacial origin. Specifically, modern humans' facial structures a slowly shrinking, which can narrow the upper airway. This is evidenced by the fact that rates of malocclusion and impacted (or non-existent) wisdom teeth are increasing in modern, Westernized countries.

Obstructive sleep apnea is a commonly seen condition characterized by multiple episodes of obstructed breathing during sleep, with intermittent hypoxia. Untreated OSA is associated with significantly higher rates of high blood pressure, diabetes, heart disease, heart attack, stroke, sudden death, and car accidents. The gold standard treatment for OSA is continuous positive airway pressure (CPAP), but compliance is poor. Initially, out of 100 patients, 20 will refuse CPAP. After one year 50% of the 80 remaining patients will be using CPAP, but only 50% will be using it effectively, leaving only 20 patients who are using CPAP effectively. (personal communication, Stepnowski).

An alternative option in people with mild to moderate OSA is a mandibular advancement device, which functions by pulling the genioglossus muscle forward. Long-term use of CPAP and mandibular advancement devices have been shown to aggravate malocclusion. Numerous surgical options are available for select patients, but only as a last resort.

In children, one uncommonly used, but effective form of treating OSA is by application of a palatal expander by an orthodontist. In theory, this option is effective due to the fact the palatal suture line is not completely fused in children. The general consensus in dentistry is that adults have fused midline palatal suture line and the hard palate cannot be expanded.

Recent work by numerous investigators suggests that palatal expansion can occur to significant degrees, even in adults. Case reports have been published with the AHI diminishing significantly after therapy. Not only can the hard palate widen, there can also be significant growth of new maxillary bone growth and anterior mandibular bone growth. Jaw development is linked to airway development.

研究设计

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

入排标准

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

入选标准

  • Documented AHI > 15 on polysomnography
  • Refuses CPAP
  • Able to fill our QOL and sleep questionnaires (pre and one year post treatment)
  • Willing to undergo CBCT radiologic testing x 2 (pre and 1 year post treatment)

排除标准

  • neurologic conditions
  • central sleep apnea
  • heart failure, seizures
  • age < 18
  • severe nasal congestion
  • insufficient teeth
  • lack of manual dexterity

研究组 & 干预措施

Homeoblock functional dental appliance

Experimental

Removable functional dental appliance to be used at during sleep for one year.

干预措施: Homeoblock (Device)

结局指标

主要结局

Polysomnographic (PSG) parameters, mainly AHI and O2 desaturation measures

时间窗: Through study completion. Data to be re-collected after one year of therapy for each participant

Comparison of PSG data between pre-therapy and post-therapy values at one year

次要结局

  • Epworth Sleepiness Scale(Comparison of data between pre-therapy and post-therapy values at one year for each participant)
  • Functional Outcome of Sleep Questionnaire (FOSQ)(Comparison of data between pre-therapy and post-therapy values at one year for each participant)
  • Nasal obstruction symptom evaluation (NOSE)(Comparison of data between pre-therapy and post-therapy values at one year for each participant)
  • Upper airway volume changes based on low-dose CT imaging (CBCT)(Comparison of CBCT data between pre-therapy and post-therapy values at one year)
  • BMI(Comparison of data between pre-therapy and post-therapy values at one year)

研究者

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

Steven Y. Park

Attending Surgeon / Assistant Professor - Otorhinolaryngology

Montefiore Medical Center

研究点 (2)

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