Clinical Evaluation of a Paediatric Sleep Diagnosis Technology
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Specificity and sensitivity of novel device
研究概览
简要总结
The objective of this project is to gather research data and subsequently evaluate algorithms to demonstrate clinical efficacy of a novel sleep apnoea detection system in the paediatric population.
The Study will involve patients who will have been referred for diagnosis of sleep apnoea, and the ultimate aim will be to compare the output of a novel apnoea detection system against in -clinic polysomnography.
详细描述
The objective of this project is to gather research data and subsequently evaluate algorithms to demonstrate clinical efficacy of a novel sleep apnoea detection system in the paediatric population.
The Study will involve patients who will have been referred for diagnosis of sleep apnoea, and the ultimate aim will be to compare the output of a novel apnoea detection system against in -clinic polysomnography.
Patients who are referred to the clinic will spend one night's sleep in the clinic. They will wear a polysomnography system (current goldstandard) and the novel device.
At the end of the trial, we will compare the diagnosis results from both systems.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 1 Year 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children older than one year old
- •Children who have been referred to a sleep clinic due to suspicion of sleep apnoea.
排除标准
- •Patients whose parents/legal guardians/carers are not fluent in English, or who have special communication needs.
- •Known allergy to the adhesive dressing.
- •Patients with physical or mental impairments who would be too distressed with additional sensors on themselves.
- •Patients with not enough space on the neck area to fit the sensor.
- •Clinical problem in the area in which the device will be attached, eg skin condition
结局指标
主要结局
Specificity and sensitivity of novel device
时间窗: 6 months
specificity and sensitivity of the output of the novel wearable device against polysomnography
次要结局
未报告次要终点