NCT04028011招募中不适用
Evaluación clínica de Una tecnología Ambulatoria Para diagnóstico Del sueño
Acurable Ltd.1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2019年9月30日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Sensitivities and Specificity for diagnosis of sleep apnoea studies with novel wearable device
研究概览
简要总结
This trial will aim to test a new wearable device for the diagnosis of Sleep Apnoea.
详细描述
This clinical trial will test a new wearable device for the diagnosis of Sleep Apnoea against Multi-channel polygraphy and Polysomnography.
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 80 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.
- •patients between the age of 18 yo and 80 yo
排除标准
- •who are not fluent in Spanish, or who have special communication needs.
- •Known allergy to the adhesive dressing.
- •patients with physical or mental impairments who would not be able to use the new technology on their own.
- •patients with very loose/saggy skin in the neck area which would unavoidably result on AcuPebble swinging if moving the neck.
- •patients with pacemakers or who have any type of implanted electronic device
结局指标
主要结局
Sensitivities and Specificity for diagnosis of sleep apnoea studies with novel wearable device
时间窗: 6 months
The study aims to compare the diagnosis result of the novel wearable device against standard of care
次要结局
未报告次要终点
研究者
研究点 (1)
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