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临床试验/NCT04305340
NCT04305340已完成不适用

Bio-signal Telemonitoring Using Electronic Textiles in a Pediatric Population

Aamir Jeewa2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2021年9月15日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
20
试验地点
2
主要终点
Validate the respiratory rate measurements obtained using the SKIIN Textile in children with and without heart disease.

研究概览

简要总结

There is a need for developing reliable and convenient technologies for telemonitoring of physiological signals such as respiration, cardiac function, and activity level in children and especially for those with heart disease. Changing symptomatology causes heart failure patients to seek medical attention in order to be assessed and potentially have medication adjusted or additional testing being undertaken. These frequent clinical encounters affect the quality of life of these children and their parents, as well as being costly for the health care system. A textile based technology for telemonitoring application that is comfortable and accurate in its data collection can help to provide real time information on physiologic parameters. The primary research objective is to determine the feasibility and validity of a textile-enabled sensor system in measuring physiologic variables, or "biological signals", related to cardiopulmonary function in children. The study will include 10 patients with heart failure, and 10 healthy controls.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Other
盲法
None

入排标准

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

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Validate the respiratory rate measurements obtained using the SKIIN Textile in children with and without heart disease.

时间窗: 40 minutes

Validate the respiratory rate measurements obtained using the SKIIN Textile in children with and without heart disease compared to the measurements obtained by the Grael 4K PSG.

Validate the pulse oximetry measurements obtained using the SKIIN Textile in children with and without heart disease.

时间窗: 40 minutes

Validate the pulse oximetry measurements obtained using the SKIIN Textile in children with and without heart disease compared to the measurements obtained by the Nonin, WristOx2TM, Model 3150, Wrist-worn Pulse Oximeter

Validate the heart rate measurements obtained using the SKIIN Textile in children with and without heart disease.

时间窗: 40 minutes

Validate the heart rate measurements obtained using the SKIIN Textile in children with and without heart disease compared to the measurements obtained by the Grael 4K PSG

次要结局

  • To extract and analyze temperature data obtained using the SKIIN Textile in children with(40 minutes)

研究者

发起方
Aamir Jeewa
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Aamir Jeewa

Staff Cardiologist

The Hospital for Sick Children

研究点 (2)

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