Clinical Evaluation of a Wearable Sleep Diagnosis Technology
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Sensitivities and Specificities for diagnosis of sleep apnoea studies
研究概览
简要总结
The primary endpoint is to evaluate the sensitivities and specificities for diagnosis of sleep apnoea of a wearable sleep diagnosis technology vs. existing gold standard.
详细描述
The clinical investigation will be performed at the Royal Free London Hospital. Physiological signals will be pseudo-anonymized and only viewed by the research team.
The Study will involve patients who will have been referred for diagnosis of sleep apnoea, will aim to determine AcuPebble's positive and negative predictive ratios, sensitivities as specificities. Likelihood ratios for diagnosis of sleep apnoea. Clinical experts will determine patients' diagnostic information using the current diagnostic standards. AcuPebble will also generate diagnostic results independently and automatically. Both set of results will be subsequently compared and the relevant performance metrics listed above will be determined.
Consecutive patients referred for sleep study will be recruited to the study. Patients that are willing to participate will be consented on the day of their sleep study and sent home with both - the Trusts usual multichannel polygraphy and the Acupebble.
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
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who have been referred to a sleep clinic due to suspicion of sleep apnoea.
排除标准
- •Age under 18 or over 70 years.
- •Subjects who are not fluent in English, or who have special communication needs.
- •Known allergy to the adhesive dressing.
- •Subjects with physical or mental impairments who would not be able to use the new technology on their own.
- •Subjects with very loose/saggy skin in the neck area which would unavoidably result on - AcuPebble swinging if moving the neck.
- •Subjects with pacemakers.
- •exclude patients who have any type of implanted electronic devices (these include patients in ICDs and left ventricular assist devices and loop recorders).
结局指标
主要结局
Sensitivities and Specificities for diagnosis of sleep apnoea studies
时间窗: 6 months
Sensitivities and Specificities for diagnosis of sleep apnoea studies
次要结局
未报告次要终点