Multicenters, Randomised Clinical Trial, to Evaluate Efficacy and Compliance of Mandibular Advancement Devices ONIRIS® vs. Laboratory Devices TALI in Patients With Syndrome of Obstructive Sleep Apnea and Hypopneas
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- ONIRIS
- 入组人数
- 211
- 试验地点
- 11
- 主要终点
- To evaluate the efficacity (non-inferiority) in terms of response between patients using mandibular advancement devices ONIRIS® and patient using devices produced in a laboratoryTALI after 2 months of use.
研究概览
简要总结
To evaluate the efficacy (non-inferiority) in terms of response between patients using custom fitted mandibular advancement devices ONIRIS® and patient using laboratory custom made devices TALI, after 2 months of use. Sleeping tests were performed.
详细描述
Open, non-inferiority, controlled and rndomised clinical trial. Six months of inclusion. Each included patient will be followed during 12 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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 severe syndrome of obstructive sleep apnea and hypopneas refusing or withdrawal from continuous positive pression ventilation
- •no dental, paro-dental or articular contraindication
- •patients never treated by mandibular advancement devices
排除标准
- •severe psychiatric or neuromuscular disorders appreciated by the investigator
- •more than 20% of apneas and central hypoapneas
- •severe syndrome of obstructive sleep apnea and hypopneas with IAH > 30% associated with another sleeping pathology
- •BMI > 30kg/m2
- •patient with an uncontrollable nausea reflex
- •epileptic patients
- •pregnant patients
- •patient without written informed consent
研究组 & 干预措施
mandibular advancement devices ONIRIS®
The patients will use the mandibular advancement devices ONIRIS®
干预措施: ONIRIS® (Device)
laboratory devices TALI
The patients will use the laboratory devices TALI
干预措施: TALI (Device)
结局指标
主要结局
To evaluate the efficacity (non-inferiority) in terms of response between patients using mandibular advancement devices ONIRIS® and patient using devices produced in a laboratoryTALI after 2 months of use.
时间窗: 2 monthes of use
The response to the treatment is defined as: * complete patient response: AHI per hour of sleep \< 10 or * partial patient response: AHI per hour of sleep reduced by 50% at visit M2 compared to baseline
次要结局
- Evolution of tolerance(at M2, M6 and M12)
- Evolution of the quality of life(at baseline, M2, M6 and M12)
- AE and SAE occuring during the study(at M2, M6 and M12)
- Evolution of AHI, AI and HI(at M2 and at M12)
- Percentage of patients responder(at M2 and M12)
- Evolution during the study of the principal criteria concerning the sleep(at baseline, M2, M6 and M12)
- Evolution of the compliance(at M2, M6 and M12)
- Evolution of arterial hypertension(at baseline, M2, M6 and M12)