NCT03325244

Brief Summary

Residency training requires hospital presence twenty-four hours a day. At times this necessitates working extended shifts, including night shifts, resulting in altered sleep patterns and sleep deprivation. Since 2003, the Accreditation Council for Graduate Medical Education (ACGME) has enforced duty hour regulations limiting shift length, the amount of weekly hours worked, and other variables governing shift work. Numerous studies have sought to determine the impact of duty hour regulations on the quality of patient care and resident education. In addition to affecting patient care, medical resident sleep deprivation also has the potential to affect residents' well-being and their ability to perform basic tasks. A study in surgical residents showed reduced efficiency and safety in performing simulated laparoscopy following a period of sleep deprivation that was worse with novices compared to experienced residents. Recently, UVA found that resident physicians have greater difficulty controlling speed and driving performance with increased reaction times and minor and major lapses in attention in the driving simulator following six consecutive night shifts. To comply with duty hour restrictions, residency programs have adopted various strategies including the creation of night float systems where residents are required to work multiple nights in a row. Reduced shift length has been associated with decreased medical errors, motor vehicle collisions, and percutaneous injuries.Surgical residents who transitioned to a night float system from 24-hour call every 3rd day reported reduced fatigue, more time for sleep and independent reading and increased family time, while nurses and patients reported improved communication and quality of patient care. In a pilot study of urology residents assigned to a 12-hour day shift (Monday-Friday), 12-hour night float (Sunday-Friday) or 24-hour home call, actigraphy was used to measure total sleep time, sleep latency and depth of sleep. Night float did not impact total sleep time or quality of sleep. However, these studies did not establish the optimal shift duration

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Apr 2017

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 7, 2017

Completed
Same day until next milestone

Study Start

First participant enrolled

April 7, 2017

Completed
7 months until next milestone

First Posted

Study publicly available on registry

October 30, 2017

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 19, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 19, 2018

Completed
Last Updated

April 27, 2021

Status Verified

April 1, 2021

Enrollment Period

10 months

First QC Date

April 7, 2017

Last Update Submit

April 26, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • sleep time

    total sleep time as measured by EEG monitor

    daily over 13 day period (Day 1 -Day 12)

Secondary Outcomes (1)

  • activity level

    daily over 13 day period (Day 1-Day 12)

Study Arms (1)

All participants

All participants will use a portable EEG monitor and FITBIT to monitor sleep and activity before and after night call

Other: EEG monitorOther: FitBit

Interventions

sleep patterns will be monitored using EEG monitor

All participants
FitBitOTHER

activity levels will be monitored

All participants

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Postgraduate year (PGY) 2, 3, and 4 Anesthesia residents

You may qualify if:

  • postgraduate year (PGY) 2, 3, and 4 Anesthesia residents

You may not qualify if:

  • history of pacemaker or other medical device
  • unable or unwilling to consent and comply with the protocol
  • history of sleep disorder

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Virginia Health System

Charlottesville, Virginia, 22908, United States

Location

Related Publications (11)

  • Philibert I, Nasca T, Brigham T, Shapiro J. Duty-hour limits and patient care and resident outcomes: can high-quality studies offer insight into complex relationships? Annu Rev Med. 2013;64:467-83. doi: 10.1146/annurev-med-120711-135717. Epub 2012 Oct 26.

    PMID: 23121182BACKGROUND
  • Sen S, Kranzler HR, Didwania AK, Schwartz AC, Amarnath S, Kolars JC, Dalack GW, Nichols B, Guille C. Effects of the 2011 duty hour reforms on interns and their patients: a prospective longitudinal cohort study. JAMA Intern Med. 2013 Apr 22;173(8):657-62; discussion 663. doi: 10.1001/jamainternmed.2013.351.

    PMID: 23529201BACKGROUND
  • Tsafrir Z, Korianski J, Almog B, Many A, Wiesel O, Levin I. Effects of Fatigue on Residents' Performance in Laparoscopy. J Am Coll Surg. 2015 Aug;221(2):564-70.e3. doi: 10.1016/j.jamcollsurg.2015.02.024. Epub 2015 Mar 4.

    PMID: 26081177BACKGROUND
  • Huffmyer JL, Moncrief M, Tashjian JA, Kleiman AM, Scalzo DC, Cox DJ, Nemergut EC. Driving Performance of Residents after Six Consecutive Overnight Work Shifts. Anesthesiology. 2016 Jun;124(6):1396-403. doi: 10.1097/ALN.0000000000001104.

    PMID: 27028468BACKGROUND
  • Landrigan CP, Rothschild JM, Cronin JW, Kaushal R, Burdick E, Katz JT, Lilly CM, Stone PH, Lockley SW, Bates DW, Czeisler CA. Effect of reducing interns' work hours on serious medical errors in intensive care units. N Engl J Med. 2004 Oct 28;351(18):1838-48. doi: 10.1056/NEJMoa041406.

    PMID: 15509817BACKGROUND
  • Barger LK, Cade BE, Ayas NT, Cronin JW, Rosner B, Speizer FE, Czeisler CA; Harvard Work Hours, Health, and Safety Group. Extended work shifts and the risk of motor vehicle crashes among interns. N Engl J Med. 2005 Jan 13;352(2):125-34. doi: 10.1056/NEJMoa041401.

    PMID: 15647575BACKGROUND
  • Ayas NT, Barger LK, Cade BE, Hashimoto DM, Rosner B, Cronin JW, Speizer FE, Czeisler CA. Extended work duration and the risk of self-reported percutaneous injuries in interns. JAMA. 2006 Sep 6;296(9):1055-62. doi: 10.1001/jama.296.9.1055.

    PMID: 16954484BACKGROUND
  • Goldstein MJ, Kim E, Widmann WD, Hardy MA. A 360 degrees evaluation of a night-float system for general surgery: a response to mandated work-hours reduction. Curr Surg. 2004 Sep-Oct;61(5):445-51. doi: 10.1016/j.cursur.2004.03.013.

    PMID: 15475093BACKGROUND
  • Ko JS, Readal N, Ball MW, Han M, Pierorazio PM. Call Schedule and Sleep Patterns of Urology Residents Following the 2011 ACGME Reforms. Urol Pract. 2016 Mar;3(2):147-152. doi: 10.1016/j.urpr.2015.05.011.

    PMID: 27840844BACKGROUND
  • Reed DA, Fletcher KE, Arora VM. Systematic review: association of shift length, protected sleep time, and night float with patient care, residents' health, and education. Ann Intern Med. 2010 Dec 21;153(12):829-42. doi: 10.7326/0003-4819-153-12-201012210-00010.

    PMID: 21173417BACKGROUND
  • Wang Y, Loparo KA, Kelly MR, Kaplan RF. Evaluation of an automated single-channel sleep staging algorithm. Nat Sci Sleep. 2015 Sep 18;7:101-11. doi: 10.2147/NSS.S77888. eCollection 2015.

    PMID: 26425109BACKGROUND

MeSH Terms

Conditions

Sleep Disorders, Circadian Rhythm

Condition Hierarchy (Ancestors)

Chronobiology DisordersNervous System DiseasesDyssomniasSleep Wake DisordersOccupational DiseasesMental Disorders

Study Officials

  • Lauren Dunn, MD

    University of Virginia Depaertment of Anesthesiolgy

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Anesthesiology

Study Record Dates

First Submitted

April 7, 2017

First Posted

October 30, 2017

Study Start

April 7, 2017

Primary Completion

January 19, 2018

Study Completion

January 19, 2018

Last Updated

April 27, 2021

Record last verified: 2021-04

Data Sharing

IPD Sharing
Will not share

Locations