Evaluation of the Overall Effectiveness Including Cardiovascular Effects of the Custom-made, Titratable Duoblock Flex SomnoDent® MAS in the Treatment of Obstructive Sleep Apnea
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- cardiovascular outcome - interventricular septum thickness
研究概览
简要总结
In this prospective trial 50 patients, diagnosed with moderate to severe obstructive sleep apnea (OSA) (AHI > 15/h sleep) will be included and treated with mandibular advancement devices (MAD). These patients will undergo cardiovascular examination; echocardiography and 24h-blood pressure monitoring, on top of the normal clinical evaluation of OSA patients. These cardiovascular examinations will take place before and 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
- •AHI > 15 events/hour
- •No other active OSA therapy in the 3 months preceding inclusion
- •Willing to participate after informed consent
- •Positive advice on OAT after DISE
排除标准
- •Insufficient teeth to support the device
- •Periodontal problems including tooth mobility
- •Active temporomandibular joint dysfunction
- •Limited maximum protrusive capacity (< 6 mm)
结局指标
主要结局
cardiovascular outcome - interventricular septum thickness
时间窗: 1 year
interventricular septum thickness
cardiovascular outcome - cardiac strain
时间窗: 1 year
cardiac strain. This will be measured on speckle tracking echocardiopgraphy (STE). STE is an echocardiographic imaging technique that analyzes the motion of heart tissue by using ultrasound waves to generate interference patterns and natural acoustic reflections. These reflections, also described as ''speckles'', are tracked consecutively frame to frame and ultimately resolved into angle-independent two-dimensional and three-dimensional strain-based sequences (3D). These sequences provide both quantitative and qualitative information regarding heart tissue deformation and motion.
cardiovascular outcome - ventricular dilatation
时间窗: 1 year
ventricular dilatation
cardiovascular outcome - stroke volume
时间窗: 1 year
stroke volume
次要结局
- efficacy on subjective complaints: visual analogue scale for snoring(1 year)
- efficacy on subjective complaints: epworth sleepiness scale(1 year)
- OSA efficacy: apnea-hypopnea index(1 year)
- Therapy compliance(1 year)
研究者
ethisch.comite@uza.be
Ethisch Comité UZ Antwerpen
University Hospital, Antwerp