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

December 13, 2024 updated by: Alexandra Ruan, Stanford University
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.

Study Overview

Detailed Description

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.

The investigators anticipate that this observational study will be the first of many studies looking at the effects of changing sleep patterns on activity and well-being

Study Type

Observational

Enrollment (Actual)

55

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • California
      • Palo Alto, California, United States, 94305
        • Stanford Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

We will recruit participants who are PGY2-5 and part of the Stanford Hospital Department of Graduate Medical Education, which means they will generally be between 26-36 years of age. We will aim to recruit an equal number of males and females which is reasonable give the demographic distribution of Anesthesia residents. Finally, we aim to have a people with a variety of races and ethnicity involved but this will not be specifically targeted or evaluated due to the limited pool of eligible subjects.

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
General Anesthesia Night Float
The residents will be followed over a three week period - one week prior to night float (baseline), the week of night float, and one week after night float (recovery). Participants will be asked to fill out PROMIS surveys weekly.
Obstetric Anesthesia Rotation
The residents will be followed and asked to wear the fitbit over a four week period during their rotation. Participants will complete three PROMIS surveys over the four week rotation, and as well as a follow-up PROMIS survey one week after the study period has completed

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Total Sleep Hours During Night Float
Time Frame: 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
3 weeks
Change in Rapid Eye Movement Sleep Hours During Night Float
Time Frame: 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
3 weeks
Change in Daily Steps during Night Float Week
Time Frame: 3 weeks
The investigators will compare Steps per 24 hour period during a baseline week, a night float week, and a recovery week
3 weeks
Trends and Recovery Time in Total Sleep Hours, Rapid Eye Movement, and Daily Steps during a random night call schedule
Time Frame: 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
4 weeks
Comparison in sleep and activity patters between a night float call schedule and a random night call schedule
Time Frame: 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.
4 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cohort 1: Change in PROMIS Positive Affect, Sleep Disturbance and Fatigue Scores During Night Float Week
Time Frame: 3 weeks
Participants will take a survey prior to starting night float, at the end of night float week, and after one recovery week. The questions on the PROMIS survey are answered on a Likert scale and normalized to a scale 1-100 based on national average. The mean value for each survey is 50. A higher score would represent increased level of positive affect.
3 weeks
Cohort 2: Change in PROMIS Positive Affect, Sleep Disturbance, and Fatigue Scores throughout the Obstetric Anesthesia Rotation
Time Frame: 3 weeks
Participants will take a baseline survey prior to starting the rotation, at the halfway point, at the end of the four weeks, and one week after the conclusion of the study period.
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
Time Frame: 4 weeks
The week to week changes in PROMIS scores between night float and a random call system will be assessed.
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Director: Alexandra Ruan, MD, Stanford University
  • Principal Investigator: Pamela Flood, MD, Stanford University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2019

Primary Completion (Actual)

November 30, 2021

Study Completion (Actual)

August 30, 2024

Study Registration Dates

First Submitted

August 24, 2021

First Submitted That Met QC Criteria

September 8, 2021

First Posted (Actual)

September 13, 2021

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

December 13, 2024

Last Verified

December 1, 2024

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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