NL-OMON48802已完成不适用
The use of a boil and bite Mandibular Advancement Device versus a custom Mandibular Advancement Device in Obstructive Sleep Apnea management - BOBYTE study
OLVG0 个研究点目标入组 58 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 58
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
- 年龄范围
- 18 至 99（—）
入选标准
- •* OSA patient confirmed by a PSG
- •* 18 years and older
- •* Sufficient understanding of Dutch language in speaking and writing
- •* Included in DISE study with METc protocol ARB 66070, NL66070.100.18
排除标准
- •Medical and psychological criteria:
- •* Clear failure or non-acceptance of previous MAD therapy
- •* Central Sleep Apnea syndrome ( > 50% of central apneas)
- •* Inability to provided informed consent
- •* Reversible morphological upper airway abnormalities (e.g. enlarged tonsils),
- •Dental criteria:
- •* Extensive periodontal disease or tooth decay (confirmed by Xray).
- •* Active temporomandibular joint disease (including severe bruxism).
- •* Restrictions in mouth opening (<25 mm) or advancement of the mandible (<5 mm).
- •* Partial or complete edentulism (less than 8 teeth in upper or lower jaw).
研究者
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