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临床试验/NCT06026761
NCT06026761已完成不适用

Validation of Myant Skiin Smart Garments for Metabolic Rate Estimation

Myant Medical Corp.1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2023年3月28日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
20
试验地点
1
主要终点
Metabolic rate

研究概览

简要总结

The goal of this observational study is to assess the use of Myant Skiin garments for the purpose of estimating metabolic rate in 20 adult (18-64 yrs) healthy participants. The main question it aims to answer is What is the accuracy of metabolic rate estimate from the Skiin algorithm utilizing Skiin data, as compared to observation and a gold-standard sensor?

Participants will be asked to perform a number of scripted tasks and their data will be assessed and compared against gold standard wearable indirect calorimetry device (COSMED K5) measurements.

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详细描述

  1. Following consent, the participants will first be asked to fill out a participant information questionnaire.
  2. Equipment setup - SKIIN: For the SKIIN garments, participants will use the elastic research belt for the study. The belt is an fabric, elastic strap that has been washed and sanitized to be worn over the skin at the chest or waist. A private area for changing will be provided. The SKIIN sensor pod will be attached to the holster on the belt to collect inertial measurement unit (IMU) data and electrocardiography (ECG) data similar to the motion and cardiac sensors in many wrist-worn activity tracking systems (e.g., Apple Watch). The electrodes must be in contact with the skin to acquire ECG data. Data from the Skiin garments will be acquired using the custom research interface provided by the supplier. The data is acquired wirelessly and stored on the local computer (and no data is sent to the cloud).
  3. Equipment setup - K5 COSMED: For the reference/criterion- standard metabolic measurement system, a wearable indirect calorimetry system will be used. This system comprises of a mask fitted over the mouth and nose connected to a portable device that analyzes breath gas composition and volume. The mask has been cleaned and sanitized prior to use with a participant. The data is acquired on the device and stored on a local computer (no data is sent to the cloud).
  4. Once the equipment has been set up for the participant, an overview of the activities and exercise tasks to be conducted during the protocol will be demonstrated.
  5. Exercise tasks are described in more detail in the attached document. In general, all exercises can be modified by the participant to modulate intensity

研究设计

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

入排标准

年龄范围
18 Years 至 64 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Healthy male and female adult volunteers (18y - 64y old)
  • must answer No to the following:
  • Have you had musculoskeletal and/or neurological foot, ankle, knee, or hip conditions, such as stroke, arthritis, trauma, joint surgery?
  • Have you been diagnosed with a neurological disorder or cognitive impairment such as Alzheimer's disease, migraine, epilepsy, dementia, Parkinson's disease, brain tumors, multiple sclerosis?
  • Have you experienced a diagnosed concussion or brain trauma in the past 6 months?
  • Do you have a condition that limits your capacity for aerobic exercise (e.g., asthma, cardiac condition)?

排除标准

  • individuals with (self-reported) lower limb conditions, neurological disorders, history of concussion/brain trauma, and/or condition limiting exercise is to mitigate additional risk for injury and/or adverse reactions associated with exercise activities.

结局指标

主要结局

Metabolic rate

时间窗: Through study completion (1 hour total), average metabolic rate calculated every 1 minute

Metabolic rate obtained via the gold standard portable metabolic cart (COSMED K5)

Heart rate

时间窗: Through study completion (1 hour total), average heart rate calculated every 1 minute

Heart rate obtained via ECG from the Skiin device

Acceleration /Activity counts

时间窗: Through study completion (1 hour total), average activity calculated every 1 minute

Epoch-based physical activity counts using accelerometer data obtained through Skiin device

次要结局

  • Weight(During participant inclusion)
  • Fitness Level(During participant inclusion)
  • Age(During participant inclusion)
  • Sex(During participant inclusion)
  • Height(During participant inclusion)

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (1)

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