NCT06093347撤回不适用
Feasibility Study to Evaluate a New Wearable Wireless Device for Monitoring Central Apnoeas in Infants and Children
适应症
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- The accuracy of the system in 15 patients, when compared with the gold standard measurement system
研究概览
简要总结
An initial small study on 15 children that are already being investigated for central sleep apnoea in the sleep unit at Sheffield Children's Hospital. The central apnoea monitor will be placed around the child's abdomen overnight alongside the sensors already being used for the clinical sleep study and the signals from the two systems will be compared to evaluate the accuracy of the new device.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Other
入排标准
- 年龄范围
- 1 Month 至 5 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who have been referred for a cardio-respiratory polygraphy sleep study.
- •Patients aged 1 month up to 5 years old.
排除标准
- •Subjects whose parents/legal guardians/carers are not fluent in English, or who have special communication needs.
- •Child anticipated to become distressed with additional sensor.
- •Child too clinically unwell to take part (as decided by clinical staff).
结局指标
主要结局
The accuracy of the system in 15 patients, when compared with the gold standard measurement system
时间窗: 24 hours
The acceptability of the sensor to the child as viewed by the parent (and child)
时间窗: End of study
As measured by researcher designed questionnaire
次要结局
未报告次要终点
研究者
研究点 (1)
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