NCT01426607已完成不适用
VASO-AM :Impact of Oral Appliance Therapy on Endothelial Function in Obstructive Sleep Apnea
University Hospital, Angers8 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2011年3月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 150
- 试验地点
- 8
- 主要终点
- change from baseline to 2-months in reactive hyperemia index (RHI), a validated measurement of endothelial function.
研究概览
简要总结
This is a randomized controlled study evaluating the impact of 2 months of oral appliance therapy on endothelial function in patients with severe obstructive sleep apnea syndrome intolerant to continuous positive airway pressure (CPAP) therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •AHI > 30
- •Intolerance to CPAP therapy
- •Signed informed consent
排除标准
- •Epworth sleepiness scale > 16/24
- •Severe cardiac and/or respiratory disease
- •BMI>32 kg/m2
- •Dental contraindication to oral appliance
结局指标
主要结局
change from baseline to 2-months in reactive hyperemia index (RHI), a validated measurement of endothelial function.
时间窗: 2 months
次要结局
- change from baseline to 2-months in markers of OSA severity(2 months)
- change from baseline to 2-months in blood pressure(2 months)
- change from baseline to 2-months in symptoms of OSA(2 months)
- evaluate treatment compliance objectively measured by an embedded micro sensor(15 weeks)
研究者
研究点 (8)
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