NCT01535521已完成不适用
Evaluation of Sleep Position Trainer for Positional Sleep Apnea Patients After Therapy With Mandibular Advancement Device (MAD)
Ethisch Comité UZ Antwerpen1 个研究点 分布在 1 个国家开始时间: 2012年2月17日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 试验地点
- 1
研究概览
简要总结
The investigators will perform a clinical trial comparing mandibular advancement device (MAD) therapy with sleep positional trainer (SPT) and the combination of MAD and SPT in patients with positional sleep apnea using MAD. Patients are invited for 2 consecutive polysomnographies (PSGs) in randomized order: one PSG with SPT, one PSG with SPT and MAD. PSGs are performed at the Antwerp University Hospital.
研究设计
- 研究类型
- Interventional
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 supine dependent Obstructive Sleep Apnea (OSA) after Mandibular Advancement Device (MAD) Therapy: Apnea Hypopnea Index (AHI) supine ≥ 2x AHI non supine
- •5 < AHI < 50/h sleep on polysomnography (PSG) with MAD in situ
- •≥ 20% supine position during PSG with the MAD in situ
- •AHI non-supine < 10/h en AHI supine ≥ 10/h on PSG with MAD in situ
- •Unchanged Body Mass Index (BMI)(BMI ± 1 kg/m²) at moment of inclusion compared to BMI at baseline PSG
排除标准
- •age < 18 years
研究组 & 干预措施
SPT in patients with MAD
Other
干预措施: Sleep Position Trainer (SPT) (Device)
研究者
Ethisch Comité UZ Antwerpen
Dr. Olivier M. Vanderveken (principal investigator)
University Hospital, Antwerp
研究点 (1)
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