ACTRN12615000037505尚未招募未知
An Open Label, Non-randomised study to evaluate the safety, efficacy, tolerability and compliance of the Tongue Tamer Mandibular Advancement Splint in patients with Obstructive Sleep Apnoea
Prof. Peter Cistulli0 个研究点目标入组 15 人开始时间: 2015年1月19日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 尚未招募
- 发起方
- 入组人数
- 15
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Non-randomised trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 o limit（—）
- 性别
- All
入选标准
- •1. Age greater than 18 years
- •2. Partial response to SomnoMed MAS, with residual moderate- severe OSA defined by polysomnograph (AHI greater than 15)
- •3. Tolerance and compliance (greater than 4 hours use per night) to MAS treatment
- •4. A clinical decision to undertake oral appliance treatment
- •5. Fluency in both written and spoken English
排除标准
- •1. Central sleep apnoea
- •2. Need for immediate therapy (eg. Sleepy drivers)
- •3. Co-existing sleep disorder (eg. Narcolepsy, shift work)
- •4. Contraindications to oral appliance therapy (periodontal disease, dental caries, less than 10 teeth per dental arch, exaggerated gag reflex)
- •5. Regular use of sedatives, narcotics, or psychoactive drugs
- •6. Pregnant or breast feeding women
- •7. Inability to understand English
研究者
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