- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05043038
Effect of Night Float Call on Sleep and Activity Patterns Among Anesthesia Residents
Study Overview
Status
Conditions
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
Enrollment (Actual)
Contacts and Locations
Study Locations
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California
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Palo Alto, California, United States, 94305
- Stanford Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
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
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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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.
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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
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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
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The investigators will compare total sleep hours per 24 hour period during a baseline week, a night float week, and a recovery week
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3 weeks
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Change in Rapid Eye Movement Sleep Hours During Night Float
Time Frame: 3 weeks
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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
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3 weeks
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Change in Daily Steps during Night Float Week
Time Frame: 3 weeks
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The investigators will compare Steps per 24 hour period during a baseline week, a night float week, and a recovery week
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3 weeks
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Trends and Recovery Time in Total Sleep Hours, Rapid Eye Movement, and Daily Steps during a random night call schedule
Time Frame: 4 weeks
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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
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4 weeks
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Comparison in sleep and activity patters between a night float call schedule and a random night call schedule
Time Frame: 4 weeks
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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.
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4 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Cohort 1: Change in PROMIS Positive Affect, Sleep Disturbance and Fatigue Scores During Night Float Week
Time Frame: 3 weeks
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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.
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3 weeks
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Cohort 2: Change in PROMIS Positive Affect, Sleep Disturbance, and Fatigue Scores throughout the Obstetric Anesthesia Rotation
Time Frame: 3 weeks
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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.
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3 weeks
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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
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The week to week changes in PROMIS scores between night float and a random call system will be assessed.
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4 weeks
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: Alexandra Ruan, MD, Stanford University
- Principal Investigator: Pamela Flood, MD, Stanford University
Publications and helpful links
General Publications
- Lee HA, Lee HJ, Moon JH, Lee T, Kim MG, In H, Cho CH, Kim L. Comparison of Wearable Activity Tracker with Actigraphy for Sleep Evaluation and Circadian Rest-Activity Rhythm Measurement in Healthy Young Adults. Psychiatry Investig. 2017 Mar;14(2):179-185. doi: 10.4306/pi.2017.14.2.179. Epub 2017 Mar 6.
- Belayachi J, Benjelloun O, Madani N, Abidi K, Dendane T, Zeggwagh AA, Abouqal R. Self-perceived sleepiness in emergency training physicians: prevalence and relationship with quality of life. J Occup Med Toxicol. 2013 Sep 21;8(1):24. doi: 10.1186/1745-6673-8-24.
- Asken MJ, Raham DC. Resident performance and sleep deprivation: a review. J Med Educ. 1983 May;58(5):382-8. doi: 10.1097/00001888-198305000-00003.
- Cavallo A, Jaskiewicz J, Ris MD. Impact of night-float rotation on sleep, mood, and alertness: the resident's perception. Chronobiol Int. 2002 Sep;19(5):893-902. doi: 10.1081/cbi-120014106.
- Davis MC, Kuhn EN, Agee BS, Oster RA, Markert JM. Implications of transitioning to a resident night float system in neurosurgery: mortality, length of stay, and resident experience. J Neurosurg. 2017 Apr;126(4):1269-1277. doi: 10.3171/2016.5.JNS152585. Epub 2016 Jul 8.
- Dunn LK, Kleiman AM, Forkin KT, Bechtel AJ, Collins SR, Potter JF, Kaperak CJ, Tsang S, Huffmyer JL, Nemergut EC. Anesthesiology Resident Night Float Duty Alters Sleep Patterns: An Observational Study. Anesthesiology. 2019 Aug;131(2):401-409. doi: 10.1097/ALN.0000000000002806.
- Nizamuddin SL, Nizamuddin J, Latif U, Tung A, Klafta JM, Lee SM, Ku CM, Stahl DL, Lee J, Shahul SS. Be Active and Be Well? A Cross-sectional Survey of US Anesthesia Residents. J Educ Perioper Med. 2020 Apr 1;22(2):E640. doi: 10.46374/volxxii-issue2-nizamuddin. eCollection 2020 Apr-Jun.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 51495
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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