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临床试验/NCT03229109
NCT03229109已完成不适用

Spectrophon Dehydration Body Monitor Accuracy Evaluation

Tirat Carmel Mental Health Center4 个研究点 分布在 1 个国家目标入组 201 人开始时间: 2017年5月3日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
201
试验地点
4
主要终点
Number of Measurements Grouped by Level or Error

研究概览

简要总结

Monitoring of a person's physical status is a key point for maintaining of "healthy life". Wearable devices provide a unique possibility for real-time monitoring. This study aims to estimate the accuracy of Spectrophon Dehydration Body Monitor (DBM) incorporated in smartwatch Samsung Gear S2 and sport band Samsung Gear Fit2 by comparing data obtained by DBM with the total weight lost during exertion.

详细描述

Reduced physical activity is considered as a risk factor for obesity, diabetes, cancer and depression. A proper exercise program can mitigate cognitive and physical decline associated with ageing. Existing general guidelines for physical activity are not universal or appropriate for every person. A personalized approach based on a subject age and unique combination of different physiological parameters would serve as a solution for finding optimal training protocols for individuals. Hence, monitoring basic physiological and biochemical parameters and obtaining information reflecting the body metabolic state is necessary for health status estimation to develop the abovementioned personally-oriented training protocols. Dehydration Body Monitor (DBM) developed by Spectrophon L.T.D. can measure sweat lost, salt concentration in sweat, and sweating dynamics, which can be used for personal physical status monitoring. This is important not only for controlling appropriate body hydration level but also for keeping kidneys "healthy". Currently, only few DBM tools are available on the market, so there is a growing need for new effective accurate real-time DBM sensors.

The main objective of current study is to estimate the accuracy of Spectrophon DBM incorporated in smartwatch Samsung Gear S2 and sport band Samsung Gear Fit2. The secondary aim of the study is to evaluate the safety-in-use of Spectrophon DBM.

Tested device:

Name: Dehydration Body Monitor; Source: Spectrophon, L.T.D.; Model: SP-DBM Firmware version: 1.5

  1. Experimental Design Healthy adults (n=200) in different age and gender groups were recruited for the study. Samsung Gear S2 smartwatch with Spectrophon DBM attached to the bottom of the smartwatch were placed on the right wrist of each participant. At the same time, Samsung Gear Fit2 sport band with Spectrophon DBM attached to the bottom of the band was placed on the left wrist of the participant. Each participant was subjected to moderate physical activity. Data from Samsung Gear S2 and Samsung Gear Fit2 was obtained simultaneously. In parallel, subject weight was also monitored using commercially available digital balancers (Shekel B-200-P).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Screening
盲法
None

入排标准

年龄范围
18 Years 至 50 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Age: older than 18, both gender.
  • Ability and willingness to sign an informed consent form for participation in the study.

排除标准

  • Presence of cardiologic or vascular disease.
  • Evidence of any other serious medical disorder.

研究组 & 干预措施

Group 1

Experimental

Age 18-25, males and females, Spectrophon dehydration body monitor was attached to subject's wrist

干预措施: Spectrophon dehydration body monitor (Device)

Group 2

Experimental

Age 26-35, males and females, Spectrophon dehydration body monitor was attached to subject's wrist

干预措施: Spectrophon dehydration body monitor (Device)

Group 3

Experimental

Age 36-45, males and females, Spectrophon dehydration body monitor was attached to subject's wrist

干预措施: Spectrophon dehydration body monitor (Device)

Group 4

Experimental

Age 46-50, males and females, Spectrophon dehydration body monitor was attached to subject's wrist

干预措施: Spectrophon dehydration body monitor (Device)

结局指标

主要结局

Number of Measurements Grouped by Level or Error

时间窗: 90 minutes

Number of measurements obtained with Dehydration Monitor with errors greater/less than 20% (as compared to Shekel B-200-P)

次要结局

未报告次要终点

研究者

发起方
Tirat Carmel Mental Health Center
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Anatoly Kreinin, MD, PHD

Head of Psychiatry Department,

Tirat Carmel Mental Health Center

研究点 (4)

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