Long Term Vital Parameter Monitoring Pilot Study to Evaluate Measurement Data Via In-ear Sensor in Comparison to Standard Polysomnography in Sleep Laboratory
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 8
- 试验地点
- 2
- 主要终点
- Extraction of vital signs out of measurement data via individually formed in-ear sensor system in comparison to standard polysomnography data in sleep laboratory
研究概览
简要总结
The purpose of this study is to evaluate the feasibility of non-intrusive 24 hours non-invasive measurements with minimized LAVIMO sensor system. The LAVIMO-system is a photoplethysmographic device for reflective mode measurements of the optical damping upper skin layers inside of the ear canal at two different wave lengths. It consists of the in-ear sensor, the electronics and a PC. Vital signs parameter like heart rate, heart rate variability, breathing and arterial blood oxygenation are monitored in patients with sleep apnoea and compared to measurements of standard polysomnography of these patients during one night in the sleep laboratory.
详细描述
In 20 patients who routinely have to undergo a polysomnographic night in sleep laboratory LAVIMO measurements like heart rate, heart rate variability, breathing and arterial blood oxygenation are performed parallel to standard polysomnography measurements and subsequently compared to the data of the standard polysomnography. The LAVIMO sensor system consists of the in- ear sensor, the electronics and a PC; the individually formed sensor is embedded into an ear mould for proper fit inside the ear canal. Inside two LEDs emit light into the adjacent skin at 760 and 905 nm wavelengths. The intensity of the backscattered light is detected by a photo detector. In the electronics, the control signals for the LEDs are provided, as well as the photo detector signal is further processed and A-D converted. The electronics also provide a wireless connection to the PC via bluetooth. Data recording, post processing and displaying are tasks of the PC. The feasibility of non- intrusive 24 hours and non-invasive measurements like heart rate, heart rate variability, breathing and oxygen saturation is proved via this minimized sensor and electronics placed at a suitable place at the body guaranteeing high wearing comfort. This includes a wireless data communication for unrestricted mobility. Subsequently the data are compared to the standard polysomnography data to extract vital signs or for example to recognize possible phases of sleep apnoea. The goal in future refering to preventive medical monitoring will be early detection of risk factors for patient's health and improvement of living conditions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 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
- •patients > 18 years who routinely have to undergo a polysomnography night
- •sleep apnoea patient
- •able to give informed consent
排除标准
- •cochlea implant
- •severe lung diseases
- •allergy against material of the sensor
- •inflammation of the middle ear
- •inflammation of auditory canal
- •occlusion because of cerumen
- •electric implants
结局指标
主要结局
Extraction of vital signs out of measurement data via individually formed in-ear sensor system in comparison to standard polysomnography data in sleep laboratory
时间窗: one night
during one polysomnographic night in sleep laboratory the patient will receive the LAVIMO in- ear sensor system and vital parameters like heart rate, heart rate variability, breathing and oxygen saturation will be monitored. Subsequently the data will be processed and compared to the standard polysomnographic data
次要结局
未报告次要终点
