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临床试验/NCT05473702
NCT05473702招募中不适用

Smart Textile Sensor System for Health Monitoring

Nanowear Inc.3 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2014年10月23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
Nanowear Inc.
入组人数
200
试验地点
3
主要终点
Efficacy against gold standard devices

研究概览

简要总结

The present study will investigate a set of biomedical sensors with a wireless data communication system and evaluate the sensors' recording quality. The sensors and wearable wireless system have been approved by Food and Drug Administration (FDA) for recording Electrocardiography (ECG), Trans Thoracic Impedance (TTI), Heart Sounds and Acitigraphy. The sensors and wireless system will be used along with conventional sensor systems (as intended to be used).

详细描述

Procedures involving people:

The sensors- electrodes, conductor channels and semi-conductor channels- are in direct contact (with the body) or indirect contact through a transient layer of polyimide or silicon rubber. The amplifiers will boost the microvolt signals into the range where they can be accurately digitized using analog to digital converter. Subsequently, a wireless data communication system will transmit and receive the digitized data and a personal computer (or other relevant device) will store and display the recorded data. The sensors used for measurement for bioimpedance will pass a modulated current of 1-5 mA (rms) at 30kHz to 100kHz through the skin into subject body. This system will be powered by a 3.7 V battery source. The sensor system(s) will draw power through this system. The sensor systems that will be used for this study are:

  1. Reusable flat gold and nanowire (gold or platinum or titanium) electrodes for ECG, ICG, TTI, EEG, EOG, EMG measurement..
  2. Reusable Nanotextured textile coated with a thin film of metal (gold or silver or platinum or titanium) electrodes for ECG, ICG, TTI, EEG, EOG, EMG measurement.
  3. Reusable Heart sound sensor, amplifier circuitry, for heart sound measurement.
  4. Reusable sensor, temperature dependent resistor circuitry, for body temperature measurement.
  5. Reusable sensor, strain dependent resistor circuitry, for measurement of respiration effort.
  6. Reusable sensor, piezoelectric circuitry, for blood pressure measurement.
  7. Reusable acceleration and rotation detection sensor with respect to x,y,z axis. sensor, amplifier circuitry, for measurement of activity (actigraphy) of the subjects.
  8. Reusable optoelectronic sensor, amplifier circuitry, for blood oxygen level measurement.
  9. Reusable sensor, piezoelectric and optoelectronic circuitry, for pulse rate measurement.
  10. A wearable wireless system: compact embedded systems and a portable battery, enclosed in a sturdy ebonite box.

The sensors will be fabricated on polyimide (KAPTON®) and polyester films, and textile fabric and will require to be mounted on subject's skin. This will be accomplished by using standard surgical waterproof tape or braces made form materials like polyester, nylon, silicone rubber sheetand textile fabric. At all times this polyimide or polyester material will be the only component in contact with test subject's skin. The sensor recordings will be taken from the test subjects in different physical states: supine position, sitting and relaxed, standing up and/or walking briskly, engaging in moderately rigorous exercise (not cardiovascular exercise).

1 Device specific protocols: 1.1 ECG measurements with Dry Electrodes:

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Healthy subject with no pre-existing conditions.
  • Subject with prehypertension
  • Subject with hypertension
  • Subject undergoing dialysis

排除标准

  • Pregnant women
  • Subjects with implantable cardiac devices (for example, pacemaker or internal cardioverter defibrillator).
  • Subjects with arrhythmia.

结局指标

主要结局

Efficacy against gold standard devices

时间窗: 1 year

Efficacy of SimpleSense Posture against gold standard devices: Simultaneous 3 axis accelerometer signal capture from SimpleSense and Visual record of posture change. Obtain correlation (with 95% confidence interval) between amplitudes of simultaneously recorded 3 axis accelerometer signal capture from SimpleSense and Visual record of posture change.

次要结局

  • Blood pressure algorithm build(1 year)

研究者

发起方
Nanowear Inc.
申办方类型
Industry
责任方
Sponsor

研究点 (3)

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