Clinical Impact of 2 Types of Mandibular Retention Devices - Narval O.R.M Cad Cam Design vs Narval O.R.M Traditional Design - on Obstructive Sleep Apnea Syndrome (OSA) Therapy: ESTAMPS Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- upper airway volume
研究概览
简要总结
ESTAMPS is a randomized clinical trial with a crossover design:
Main objective is to compare impact of 2 different Mandibular Retention Device (MRD) designs (Narval MRD CadCam (CC) design vs Narval MRD traditional (trad) design) on upper airway volume
secondary objectives: To evaluate the maximal mandibular propulsion according to the type of MRD To evaluate benefits on quality of life, sleepiness and OSA symptoms To evaluate impact of MRD design on therapy efficacy and tolerance To evaluate impact of MRD design on mandibular positioning
详细描述
Hypothesis ORCADES results suggest that Narval O.R.M CC could be more efficient than Narval MRD trad to reduce AHI whatever the initial OSA severity 79% of CC MRD patients have at least an AHI reduction of 50% (vs. 61% with a trad Narval MRD, p=0.0031) 66% of CC MRD patients get a complete answer with an AHI reduction <10 (vs. 49% with a trad Narval MRD, p=0.0017) The investigators think that differences seen in the ORCADES study between the 2 MRD is due to a different impact on upper airway volume
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 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
- •* Patients with a mild OSA syndrome (5\15) who do not tolerate or refuse CPAP therapy
- •* Patients ≥ 18 years old
- •* Patient is able to fully understand study information and provide written informed consent
排除标准
- •MRD contraindication
- •Clinical trial classic exclusion criteria
研究组 & 干预措施
Narval O.R.M CC™
First mandibular retention device : Narval O.R.M CC™
干预措施: Mandibular Retention Device (Device)
Narval O.R.M™ trad
Second mandibular retention device : Narval O.R.M TRAD™
干预措施: Mandibular Retention Device (Device)
结局指标
主要结局
upper airway volume
时间窗: 1 month
investigators will measure upper airway volume (cm3) changes produced by 2 different Mandibular Retention Devices in Obstructive sleep apnea syndrome (OSA) patients
次要结局
- maximal mandibular propulsion(1 month)
- quality of sleep(1 month)
- sleepiness(1 month)
- MRD therapy efficacy(1 month)
- mandibular positioning(1 month)
- Occlusal vertical dimension(1 month)