ACTRN12618001995268已完成1 期
Targeted Therapy to Treat Sleep Apnoea: A Novel Personalised Approach Using Mandibular Advancement Split Therapy Plus Combination Therapy in Incomplete Responders
euRA0 个研究点目标入组 109 人开始时间: 2018年12月12日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 109
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 80 Years（—）
- 性别
- All
入选标准
- •Adult men and women with OSA aged between 18 and 80 years who are otherwise healthy.
- •Have been recommended MAS by their sleep physician for treatment of their OSA and have had an incomplete therapeutic response (residual AHI>10 events/h sleep)
- •Are able to undergo an MRI scan, and do not have any dental implants, crowns or bridges (up to n=40 only for imaging sub-study)
- •Participants who are willing and able to give written informed consent and willingness to participate and comply with the study procedures
排除标准
- •People with contraindications to MRI, which include the presence of a pacemaker, metal shards (e.g. from shrapnel or association with meta work) or other metal implants in the body, in particular dental crowns, implants or bridges (n=40 subset only)
- •Contraindications to MAS treatment (periodontal disease or dental caries, less than 10 teeth per dental arch, exaggerated gag reflex)
- •Patients taking medications known to affect sleep or pharyngeal muscle activity.
- •Patients with previous side effects or known allergy to zolpidem
- •People with intellectual or mental impairment or any condition that may interfere with their ability to consent for themselves
- •Patients with a previous history of addiction to alcohol or drugs
- •Women lactating, pregnant or of childbearing potential who are not willing to avoid becoming pregnant during the study
- •Patients with any other medical condition which may interfere in the evaluation of the study
研究者
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