Sleep Disorders, Circadian RhythmNCT03325244
The Impact of Night Float on Anesthesiology Resident Sleep Patterns
An observational study of Sleep Disorders, Circadian Rhythm, run by University of Virginia at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Sleep Disorders, Circadian Rhythm
- What is being tested?
- EEG monitor and FitBit
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Apr 2017to 19 Jan 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Postgraduate year (PGY) 2, 3, and 4 Anesthesia residents
Who may be able to join
- postgraduate year (PGY) 2, 3, and 4 Anesthesia residents
Who cannot join
- history of pacemaker or other medical device
- unable or unwilling to consent and comply with the protocol
- history of sleep disorder
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Virginia Health System
Charlottesville, Virginia, 22908
About this study
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
Read the detailed description
Participants wear a portable EEG monitor and a FITBIT activity monitor while attempting to sleep while on night call and at home for a baseline reading
- Conditions
- Sleep Disorders, Circadian Rhythm
- Being tested
- EEG monitor, FitBit
- Medical subject headings
- Sleep Disorders, Circadian Rhythm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EEG monitorOther
sleep patterns will be monitored using EEG monitor
FitBitOther
activity levels will be monitored
| Study group | Role | What they receive |
|---|---|---|
| All participants | All participants will use a portable EEG monitor and FITBIT to monitor sleep and activity before and after night call Receives: Other: EEG monitor; Other: FitBit |
What is being measured
The primary outcome is the main question the study is designed to answer.
sleep time
total sleep time as measured by EEG monitor
Measured: daily over 13 day period (Day 1 -Day 12)
Secondary outcomes (1)
activity level
- as measured by activity monitor
Measured: daily over 13 day period (Day 1-Day 12)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2017
- Study start7 Apr 2017
- Primary completion19 Jan 2018
- Study completion19 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Sleep Disorders, Circadian RhythmStudies of the same condition, open and under way.
- More trials run by University of VirginiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Virginia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lauren Dunn, MD, University of Virginia
- Investigators
- Lauren Dunn, MD, Principal investigator, University of Virginia Depaertment of Anesthesiolgy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03325244
- Sponsor's protocol ID
- 11590
- Status last verified
- Apr 2021
- First submitted
- 7 Apr 2017
- Last updated
- 27 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 23121182Sen 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.
PubMed 23529201Tsafrir 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.
PubMed 26081177Huffmyer 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.
PubMed 27028468Landrigan CP, Rothschild JM, Cronin JW, Kaushal R, Burdick E, Katz JT, Lilly CM, Stone PH, Lockley SW, Bates DW, Czeisler CA; New Collective Author. 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.
PubMed 15509817Barger 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.
PubMed 15647575Ayas 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.
PubMed 16954484Goldstein 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.
PubMed 15475093Ko 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.
PubMed 27840844Reed 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.
PubMed 21173417Wang 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.
PubMed 26425109
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Night Float on Anesthesiology Resident Sleep Patterns
- ClinicalTrials.gov ID
- NCT03325244
- Acronym / sponsor ID
- 11590
- Conditions
- Sleep Disorders, Circadian Rhythm
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of VirginiaUniversity, hospital or other
- Study start
- 7 Apr 2017 (actual)
- Primary completion
- 19 Jan 2018 (actual)
- Study completion
- 19 Jan 2018 (actual)
- First posted
- 30 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
Participants wear a portable EEG monitor and a FITBIT activity monitor while attempting to sleep while on night call and at home for a baseline reading
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All participants | – | Other: EEG monitor, Other: FitBitAll participants will use a portable EEG monitor and FITBIT to monitor sleep and activity before and after night call |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Postgraduate year (PGY) 2, 3, and 4 Anesthesia residents
Key inclusion criteria (1 listed)
- postgraduate year (PGY) 2, 3, and 4 Anesthesia residents
Key exclusion criteria (3 listed)
- history of pacemaker or other medical device
- unable or unwilling to consent and comply with the protocol
- history of sleep disorder
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EEG monitorsleep patterns will be monitored using EEG monitor | Other | All participants |
| FitBitactivity levels will be monitored | Other | All participants |
Primary outcome
sleep time
Time frame: daily over 13 day period (Day 1 -Day 12)
total sleep time as measured by EEG monitor
1 secondary outcome
activity level
Time frame: daily over 13 day period (Day 1-Day 12)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2021.
- Background: PubMed 23121182Philibert 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.
- Background: PubMed 23529201Sen 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.
- Background: PubMed 26081177Tsafrir 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.
- Background: PubMed 27028468Huffmyer 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.
- Background: PubMed 15509817Landrigan CP, Rothschild JM, Cronin JW, Kaushal R, Burdick E, Katz JT, Lilly CM, Stone PH, Lockley SW, Bates DW, Czeisler CA; New Collective Author. 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.
- Background: PubMed 15647575Barger 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.
- Background: PubMed 16954484Ayas 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.
- Background: PubMed 15475093Goldstein 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.
- Background: PubMed 27840844Ko 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.
- Background: PubMed 21173417Reed 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.
- Background: PubMed 26425109Wang 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lauren Dunn, MD principal investigator
University of Virginia Depaertment of Anesthesiolgy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sleep Disorders, Circadian Rhythm, run by University of Virginia at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
sleep time (time frame: daily over 13 day period (Day 1 -Day 12)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03325244, which also lists 11 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2021.