NCT07191314招募中不适用
Long-term Evaluation of a Nasopharyngeal Airway
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 4
- 主要终点
- Change in severity of apnea hypopnea index (AHI)
研究概览
简要总结
This long-term follow-up study will permit continued device use for participants of the parent study (NCT06677151).
During study participation the study team will stay in contact with participants as necessary. Additionally, patients will undergo clinical follow-up as needed with their physician(s). At 12 months, participants will complete sleep questionnaires as part of this long-term follow-up period.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants who completed the parent study (HUM00179497) and wish to continue using the NPA-OSA device.
排除标准
- •The participants who were non-compliant with the NPA-OSA device during their participation in the parent study.
结局指标
主要结局
Change in severity of apnea hypopnea index (AHI)
时间窗: Baseline (day 0), 24 months
The AHI is calculated by dividing the number of apnea events by the number of hours of sleep.
次要结局
未报告次要终点
研究者
Louise O'Brien
Professor, Sleep Medicine
University of Michigan
研究点 (4)
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