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临床试验/NCT05043038
NCT05043038已完成不适用

Effect of Night Float Call on Sleep and Activity Patterns Among Anesthesia Residents

Stanford University1 个研究点 分布在 1 个国家目标入组 55 人开始时间: 2019年8月1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
55
试验地点
1
主要终点
Change in Total Sleep Hours During Night Float

研究概览

简要总结

With increasing awareness about physician fatigue and its effect on patient safety, residency programs are increasingly transitioning to a night float call system. In other industries, multiple night shifts in a row can cause a disruption in the circadian rhythm, sleep debt, shift work disorder, that is related to chronic medical conditions such as obesity and cardiovascular disease. We will evaluate the effect of different call structures on resident activity, sleep and self reported measures of wellness using a commercially available Fitbit device.

详细描述

Participants will be recruited via an email once they are scheduled for a week of night float in the Stanford Main Operating room or on their Obstetric Anesthesia rotation. Potential participants who are taking prescription medications that might affect their alertness during the study period will not be enrolled.

The investigators will quantify the changes in sleep pattern and activity during different call rotations. Self reported aspects of well being including fatigue, physical function, and positive affect will be assessed with NIH PROMIS surveys periodically during the study period. The investigators will use the Fitbit Alta HR data to quantify the change in total amount of sleep, sleep interruption and sleep phase and steps per day. Data will be analyzed only when it is coincident with heart rate data to correct for periods when the device is not used.

Activity will not alter from the participants normal except that they will wear the Fitbit and respond to the NIH PROMIS surveys over the study period.

Data from NIH PROMIS surveys, Fitbit and provided demographic information including age, sex and BMI, and number of previous night float periods previously completed. After association, data will be completely de-identified.

All data will be normalized to the participant's baseline value during the run-in week. The call week and post call week will be analyzed with a time series mixed effects model using R and/or NONMEM (a program for Nonlinear Mixed Effects Modeling). The effects of the above demographic variables will be assessed as potential covariates.

研究设计

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

入排标准

性别
All
接受健康志愿者
是

入选标准

  • •All residents (PGY2-5) who have been scheduled for either general operating room night float call or obstetric anesthesia rotation

排除标准

  • •Participants who report taking prescription medications that may effect alertness during the study period will not be enrolled.

结局指标

主要结局

Change in Total Sleep Hours During Night Float

时间窗: 3 weeks

The investigators will compare total sleep hours per 24 hour period during a baseline week, a night float week, and a recovery week

Change in Daily Steps during Night Float Week

时间窗: 3 weeks

The investigators will compare Steps per 24 hour period during a baseline week, a night float week, and a recovery week

Change in Rapid Eye Movement Sleep Hours During Night Float

时间窗: 3 weeks

The investigators will compare total Rapid Eye Movement sleep hours per 24 hour period during a baseline week, a night float week, and a recovery week

Comparison in sleep and activity patters between a night float call schedule and a random night call schedule

时间窗: 4 weeks

The investigators will compare trends in sleep hours, REM sleep, and steps between night float and random call schedule. Time to recovery to baseline sleep patterns will be assessed.

Trends and Recovery Time in Total Sleep Hours, Rapid Eye Movement, and Daily Steps during a random night call schedule

时间窗: 4 weeks

The investigators will compare change in fitbit sleep and steps data during random call night schedule and recovery after the call night during the obstetric anesthesia rotation

次要结局

  • Cohort 2: Change in PROMIS Positive Affect, Sleep Disturbance, and Fatigue Scores throughout the Obstetric Anesthesia Rotation(3 weeks)
  • Cohort 1: Change in PROMIS Positive Affect, Sleep Disturbance and Fatigue Scores During Night Float Week(3 weeks)
  • Change in PROMIS Positive Affect, Sleep Disturbance and Fatigue Scores over the study period in a night float versus a random call night system(4 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Alexandra Ruan

Clinical Assistant Professor

Stanford University

研究点 (1)

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