PROMAD : Predicting Therapeutic Outcome of Mandibular Advancement Device Treatment in Obstructive Sleep Apnea
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
- 否
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
ethisch.comite@uza.be
prof. Marc Braem, DDS, PhD
University Hospital, Antwerp
