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临床试验/NCT03640416
NCT03640416Unknown不适用

The Feasibility to Use Wearable Devices to Collect Physiologic Data During Night Shifts - A Pilot Study

Rambam Health Care Campus2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2018年10月最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
30
试验地点
2
主要终点
assessment of sleep duration (hours)

研究概览

简要总结

There is an increase interest in the use of wearable activity trackers and wearable technology in the various medical fields. Such devices can increase physical activity and decrease weight significantly.

Field and laboratory studies have shown that shift work can alter circadian rhythms, disrupt the sleep cycle, and hinder human performance. Sleep deprivation reduces alertness level, and may increase reaction time, cause memory impairment and impaired motor skills. Disrupted circadian rhythms, a well-known consequence of atypical work schedules, have been linked to neurodegeneration.

The aim of this pilot study is to evaluate the feasibility of wearable devices to collect data on physiologic parameters during sleep and awake under stress conditions.

The study population will include 30 Rambam Health Care Campus medical residents who work nights on call. The length of experiment per participant will be one month.

Subjective data on stress will be collected during the study. Data on vital signs and sleep stages will be collected through a smart watch Fitbit® Charge HR.

详细描述

Background There is an increase interest in the use of wearable activity trackers and wearable technology in the various medical fields. Such devices can increase physical activity and decrease weight significantly.

Shift work is usually referred to as dividing working hours among two or more occupational groups in order to cover the time needed for duty performance or for production process, and shift workers perform duties outside the regular working hours.

Field and laboratory studies have shown that shift work can alter circadian rhythms, disrupt the sleep cycle, and hinder human performance. Sleep deprivation reduces alertness level, and may increase reaction time, cause memory impairment and impaired motor skills. Disrupted circadian rhythms, a well-known consequence of atypical work schedules, have been linked to neurodegeneration.

Aim:

A pilot study to evaluate the feasibility of wearable devices to collect data on physiologic parameters during sleep and awake under stress conditions (night shifts).

研究设计

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

盲法说明

No masking needed.

入排标准

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

入选标准

  • A medical resident working nights on call at Rambam.
  • Use a smart phone (Android OS) with a data plan.

排除标准

  • Pregnancy and lactation.
  • Medications:
  • CNS (Central Nervous System) stimulants - Ritalin (methyphenidate), Concerta.
  • Beta Blockers, Calcium channel Blockers
  • glucocorticoids
  • Unwilling to carry smart phone or wearable device on a continuous basis during shifts and at least 24 hours before and after shifts.

研究组 & 干预措施

Medical residents

Other

Rambam Health Care Campus medical residents who work nights on call. Fitbit® Charge HR smart watch

干预措施: Fitbit® Charge HR smart watch (Device)

结局指标

主要结局

assessment of sleep duration (hours)

时间窗: one month per participant

calculated using the Fitbit® charge HR device

次要结局

  • heart rate (beats/mins)(one month per participant)
  • steps taken (number)(one month per participant)
  • Trail Making test(one month per participant)
  • blood pressure (mmhg)(one month per participant)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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