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临床试验/NCT05350046
NCT05350046已完成不适用

Development of Physical Activity Features for Ear-worn Devices

57GGardner1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2022年7月11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
30
试验地点
1
主要终点
Accuracy of ear-worn device information

研究概览

简要总结

This study incorporates data collection to aid in development of software features related to physical activity for users of ear-worn devices.

详细描述

This exploratory study involves data collection of adults performing physical activities and activities of daily living for the purpose of comparing data collected by the ear-worn device under test and established gold standard/reference devices and consumer electronic devices. Data collected will be used in the development of software features related to physical activities to benefit the experience of ear-worn device users.

研究设计

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

入排标准

年龄范围
40 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Age 40 - 85
  • •Minimum height 5'3"
  • •Fully vaccinated against Covid -19
  • •Willing and able perform various exercise activities at a light and moderate relative intensity, such as riding a stationary bike, walking and jogging on a treadmill, and performing squatting movements.
  • •Non-smoker for the past 6 months.
  • •Willing to abstain from caffeine and alcohol 6 hours before participation.
  • •Willing to fast from eating 4 hours before participation.

排除标准

  • •History of chronic heart disease or significant cardiac events (e.g. cardiac arrythmia).
  • •Diagnosed with diabetes mellitus or other metabolic disorder.
  • •History of cerebral vascular accident.
  • •History of pulmonary disorder.
  • •Experiencing orthopedic injury or disorders that restrict movement or cause painful physical activity.
  • •History of neurodegenerative or neuromuscular pathology.
  • •Advised by a healthcare professional to not participate in physical activity.

研究组 & 干预措施

Physically active adults

Experimental

A cohort of physically-active adults will use ear-worn prototype devices and established gold standard and comparator devices during rest periods, physical activity, and various activities of daily living.

干预措施: Ear-worn prototype devices (Device)

结局指标

主要结局

Accuracy of ear-worn device information

时间窗: data collection during activities ranging in duration from 5-20 minutes

Accuracy of information provided by the ear-worn device in comparison to the comparator devices using mean absolute percentage error calculations

次要结局

未报告次要终点

研究者

发起方
57GGardner
申办方类型
Industry
责任方
Sponsor Investigator
主要研究者

57GGardner

Principal Investigator

Sonova AG

研究点 (1)

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