Evaluation of Performance, Usability, and Reliability of a Novel Device for Continuous Collection of Physiological Data
2019年1月22日 更新者：MC10 Inc.
A Study to Evaluate the Performance, Usability, and Reliability of a Novel Device for Continuous Collection of Physiological Data in Healthcare and Remote Settings
Study objective: The primary objective of the clinical investigation is to evaluate the accuracy of BioStamp nPoint system algorithm measurements.
Study design: A single-site, non-significant risk, open-label, prospective non-randomized clinical investigation designed to validate the accuracy of the various physiological parameters that the Wearable Sensor Patches acquire and the system processes.
研究概览
地位
完全的
条件
研究类型
介入性
注册 (实际的)
30
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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Ohio
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Cincinnati、Ohio、美国、45212
- CTI Clinical Research Center
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 至 99年 (成人、年长者)
接受健康志愿者
是的
有资格学习的性别
全部
描述
Inclusion Criteria:
- Male or female volunteers, at least 18 years of age at the time of screening visit;
- Fluent in English;
- The subject is willing to comply with the protocol specified evaluations;
- Subject is willing and cognitively able to sign informed consent
Exclusion Criteria:
- Pregnancy;
- Positive urine drug screen
- History of active (clinically significant) skin disorders;
- History of allergic response to silicones or adhesives;
- Subjects with electronic implants of any kind (e.g. pacemaker)
- History of sleep disorders or self-reported insomnia or other sleep conditions;
- Broken, damaged or irritated skin or rashes near the sensor application sites;
- Subjects that are MC10 employees or shareholders, or a spouse or child of an MC10 employee or shareholder;
- Subjects who are physically or cognitively unable to normally perform activities of daily living, assessed at the discretion of the investigator.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：其他
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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其他：Single Arm
This single arm consists of all subjects which will interact with the device under investigation as well as comparator devices. This includes the Physiological signal monitor intervention, Heart rate and heart rate variability comparison device intervention, Respiration rate comparison device intervention, and Activity classification intervention. |
Wireless remote monitoring system intended for use by researchers and healthcare professionals for continuous collection of physiological data in home and healthcare settings.
FDA cleared reference device that monitors heart rate and heart rate variability in subjects
FDA cleared reference device that monitors respiration rate in subjects
Visual annotation of subject posture and other activities used for reference
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Accuracy of Heart Rate Measured in Beats Per Minute Compared to Reference Device
大体时间：2 days after informed consent
|
Heart rate as measured by the subject device in beats per minute will be compared to the reference device.
The Mean Absolute Error (MAE) between measurements from each device is presented.
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2 days after informed consent
|
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Accuracy of Heart Rate Variability Measured by Root Mean Square of Successive Differences (HRV RMSSD) Compared to the Reference Device
大体时间：2 days after informed consent
|
Heart Rate Variability RMSSD is measured by the subject device determined by root mean square of successive differences in neighboring RR intervals and will be compared to the reference device.
The Mean Absolute Error (MAE) between measurements from each device is presented.
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2 days after informed consent
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Accuracy of Heart Rate Variability Measured by Low Frequency Content to High Frequency Content Ratio (HRV Ratio) Compared to the Reference Device
大体时间：2 days after informed consent
|
HRV Ratio as measured by the subject device determined by low frequency content to high frequency content ratio (HRV Ratio) in beats per minute will be compared to the reference device.
The Mean Absolute Error (MAE) between measurements from each device is presented.
|
2 days after informed consent
|
|
Accuracy of Respiration Rate Measured in Breaths Per Minute Compared to the Reference Device
大体时间：2 days after informed consent
|
Respiration rate as measured by the subject device in breaths per minute will be compared to the reference device.
The Mean Absolute Error (MAE) between measurements from each device is presented.
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2 days after informed consent
|
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Accuracy of Activity Classification as Compared to Visual Annotation
大体时间：2 days after informed consent
|
The device under test will classify a subjects activity into sleeping, standing, sitting, lying, walking and other activities as the subject performs various predefined activities, which are annotated by an observer.
The device's Activity Classification will be compared to the observer's annotation.
The percentage of correct classifications by the device against indicated visual observation is presented.
The percent correct is not a per subject average, but is the percentage of all activity classifications which were correct when compared to ground truth observation.
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2 days after informed consent
|
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Accuracy of Step Count Compared to an Observer's Manual Count
大体时间：2 days after informed consent
|
The number of steps reported by the device under test during a 6 minute walk test will be compared to an observer's manual count of the number of steps taken.
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2 days after informed consent
|
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Accuracy of Sleep Onset Time (Hours, Minutes, and Seconds), Sleep Wake Time (Hours, Minutes, and Seconds) as Compared to an Observer's Visual Annotation
大体时间：2 days after informed consent
|
Sleep onset and wake times as reported by the device under test will be compared to an observer's visual annotation of the sleep onset and wake times.
The Mean Absolute Error (MAE) between times as indicated by the device and observed times is presented.
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2 days after informed consent
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Accuracy of Posture Classification as Compared to Visual Annotation
大体时间：2 days after informed consent
|
The device under test will classify a subjects activity into sleep posture, standing posture, and sitting posture as the subject performs various predefined activities, which are annotated by an observer.
The device's Posture Classification will be compared to the observer's annotation.
The percentage of correct classifications by the device against indicated visual observation is presented.
The percent correct is not a per subject average, but is the percentage of all posture classifications which were correct when compared to ground truth observation.
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2 days after informed consent
|
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Number of Sensors That Remained Sufficiently Adhered to Subjects for 24 Hours as Assessed by a 5 Point Scale
大体时间：2 days after informed consent
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The level of sensor adhesion will be assessed by a 5 point scale (0- sensor is greater than or equal to 90% of sensor adhered, 4-sensor completely detached from subject).
Sensors receiving scores of 0 and 1 will be determined to have acceptable adhesion, while scores of 2, 3, and 4 will be considered unacceptable adhesion.
The percentage of sensors which had acceptable adhesion at sensor removal is presented.
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2 days after informed consent
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
赞助
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2017年7月31日
初级完成 (实际的)
2017年8月25日
研究完成 (实际的)
2017年8月30日
研究注册日期
首次提交
2017年8月16日
首先提交符合 QC 标准的
2017年8月17日
首次发布 (实际的)
2017年8月22日
研究记录更新
最后更新发布 (实际的)
2019年1月25日
上次提交的符合 QC 标准的更新
2019年1月22日
最后验证
2019年1月1日
更多信息
与本研究相关的术语
其他研究编号
- MC10-PTL-103
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
不
药物和器械信息、研究文件
研究美国 FDA 监管的药品
不
研究美国 FDA 监管的设备产品
是的
在美国制造并从美国出口的产品
不
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.
Physiological signal monitor的临床试验
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Centre Hospitalier Universitaire de Nice撤销
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Bio-Signal Group Corp.National Institute of Neurological Disorders and Stroke (NINDS); State University of New York... 和其他合作者完全的
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Medtronic Cardiac Rhythm and Heart Failure完全的
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Children's Mercy Hospital Kansas CityGabi SmartCare完全的
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University of FloridaNational Institute on Alcohol Abuse and Alcoholism (NIAAA)完全的