NCT01476917已完成2 期
The ATLAST Long-Term Study. A Multicenter, Prospective, Long-Term Study of the Attune Sleep Apnea System for the Treatment of Obstructive Sleep Apnea (OSA)
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 39
- 试验地点
- 12
- 主要终点
- Mean number of hours per night of device use over a 3-month period
研究概览
简要总结
The Study is a multi-center, prospective, open label, single-arm, three-month, long-term study of the Attune Sleep Apnea System for the treatment of obstructive sleep apnea (OSA). The objective of the study is to monitor long-term use of the Attune Sleep Apnea System.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject participated in the ATLAST Study, and completed the 28-day take-home period
- •Subject understands the Study protocol and is willing and able to comply with Study requirements and sign the informed consent form.
- •The study physician and investigator believe that study participation is appropriate for the subject.
- •Subject has at least one molar in each of the four quadrants of the mouth (right upper, right lower, left upper, and left lower).
排除标准
- •Female subjects who are pregnant or intend to become pregnant during the study period.
- •Poor nasal patency as evidenced by the inability to breathe through the nose with the mouth closed.
- •Oral cavity infection or any other oral or dental condition or problem that would limit subject use of the Attune Sleep Apnea System
- •History of any OSA surgical treatment
结局指标
主要结局
Mean number of hours per night of device use over a 3-month period
时间窗: Each night's use
Nightly use will be monitored over a 3-month take-home period.
次要结局
未报告次要终点
研究者
研究点 (12)
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