ISRCTN16013232进行中（未招募）未知
Can mandibular advancement device treatment for obstructive sleep apnoea reduce nocturnal gastro-oesophageal reflux: a feasibility study
试验速览
- 阶段
- 未知
- 状态
- 进行中（未招募）
- 入组人数
- 44
研究概览
简要总结
2023 Protocol article in https://doi.org/10.1136/bmjopen-2023-076661 (added 25/08/2023)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Adult patients aged 18 years old and over
- •2. Confirmed OSA with Apnoea-Hypopnoea Index (AHI) score between 10 and 30
- •3. Confirmed gastro-oesophageal reflux disease with greater than 6 percent of acid exposure time < pH 4 over 24 hours
- •4. Patient will not have previously had CPAP or MAD therapy
- •5. Sufficient healthy teeth to support a mandibular advancement device (10 teeth in each jaw, no periodontal pockets > 5, no frank cavitation or loose crowns/bridges)
- •6. Willing and able to provide informed consent to the study
排除标准
- •1. Pregnancy or breast feeding
- •2. Unable or unwilling to stop GORD medication 2 days prior to assessment or unable to undergo manometry and pH impedence testing
- •3. Known liver disease or oesophageal/gastric varices
- •4. Previous surgery or intervention for reflux such as fundoplication
- •5. Any previous treatment for oesophageal neoplasia.
- •6. Unable/unwilling to tolerate either a CPAP mask or a mandibular advancement device
- •7. Medical history likely to impact on attendance or 24-hour impedance testing
- •8. Participation in other research within previous 30 days
研究者
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