ISRCTN02309506已完成未知
Crossover randomised controlled trial of oral mandibular advancement devices for obstructive sleep apnoea-hypopnoea
Papworth Hospital NHS Foundation Trust (UK)0 个研究点目标入组 90 人开始时间: 2010年3月18日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 90
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Aged greater than or equal to 18 years, either sex
- •2. Obstructive sleep apnoea-hypopnoea confirmed by respiratory polysomnogram with apnoea-hypopnoea index (AHI) 5 to 30/hours
- •3. Excessive daytime sleepiness (ESS) greater than or equal to 11 and/or participant reported sleepiness
- •4. Sufficient teeth to allow satisfactory device retention
- •5. Ability to give written informed consent
排除标准
- •1. Primary central sleep apnoea
- •2. Coexistent sleep disorder or drug treatment considered likely to have significant impact on symptoms (especially sleepiness) or MAD effectiveness
- •3. Severe and/or unstable cardiovascular disease judged by clinician to warrant immediate continuous positive airway pressure (CPAP)
- •4. Other medical or psychiatric disorder judged likely to adversely interact with MAD or confound interpretation of its effectiveness
- •5. Significant periodontal disease or tooth decay; partial or complete edentulism; presence of fixed orthodontic devices
- •6. Temporomandibular joint pain or disease
- •7. Severe bruxism
- •8. Restriction in mouth opening or advancement of mandible
- •9. Respiratory failure
- •10. Inability to give informed consent or comply with the protocol
- •11. Pregnant women
- •12. Any other significant clinical contra-indication, e.g. disabling sleepiness upgrading the obstructive sleep apnoea-hypopnoea (OSAH) to severe
研究者
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