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临床试验/NCT01532050
NCT01532050已完成4 期

PROMAD : Predicting Therapeutic Outcome of Mandibular Advancement Device Treatment in Obstructive Sleep Apnea

ethisch.comite@uza.be2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2012年2月最近更新:
适应症

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
100
试验地点
2
主要终点
Predictive value of DISE and CFD

研究概览

简要总结

The present research intends to focus clinically on selecting the right type of patient for mandibular advancement devices (MAD) therapy using screening tools such as advanced imaging and computational methods based on CT-Scan images as well as drug-induced sleep nasendoscopy techniques with simulation of the mandibular repositioning. The core of the research project relies on known and established methods accepted in several neighboring fields, but aims at the transfer of this knowledge by integrating it into this new domain. Doing so, the proposed biomedical research is directed towards clinical applications that incorporate innovative developments on the level of the diagnosis and therapy of a specific disease, being obstructive sleep apnea syndrome (OSAS). Furthermore, this study aims at registering objective compliance during MAD therapy.

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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age ≥ 18 years
  • body mass index (BMI) ≤ 35 kg/m²
  • OSAS, as defined by the American Academy of Sleep Medicine Task Force
  • apnea-hypopnea index (AHI) < 50

排除标准

  • Other sleep disorders (i.e. parasomnias)
  • Invasive upper airway surgery for sleep-disordered breathing
  • Known genetic disorders with craniofacial and/or upper airway malformations
  • Use of benzodiazepine and/or antidepressants
  • Known history of psychiatric disease
  • Known history of fibromyalgia and/or chronic fatigue syndrome
  • Dental contra-indications: functional restrictions of the temporomandibular joint, insufficient dentition with pathological changes, insufficient retention for MAD use

结局指标

主要结局

Predictive value of DISE and CFD

时间窗: 3 months

Positive and negative predictive values for AHI based treatment outcome

次要结局

未报告次要终点

研究者

发起方
ethisch.comite@uza.be
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

ethisch.comite@uza.be

prof. Marc Braem, DDS, PhD

University Hospital, Antwerp

研究点 (2)

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