NCT01623674

Brief Summary

The aim of the study was to asses the effect of sleep deprivation during nightshift by monitoring 30 surgeons in unit of surgical gastroenterology in 4 consecutive days. The first day was pre call= day 1, second day was on call= day 2, third day was the first post call day = day 3 and fourth day was the second post call= day 4. The surgeons were monitored in order to asses how performance was on call compared to pre call and post call. The hypothesis was that they would perform worse on call than pre call, and again slightly worse post call.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Dec 2011

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2011

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2012

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

June 18, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 20, 2012

Completed
Last Updated

May 21, 2013

Status Verified

May 1, 2013

Enrollment Period

3 months

First QC Date

June 18, 2012

Last Update Submit

May 19, 2013

Conditions

Effect of Sleep Deprivation

Keywords

Sleep deprivation in surgeons during night shifts and the effect on performance.

Outcome Measures

Primary Outcomes (1)

  • laparoscopic simulation

    pre call and on call

Secondary Outcomes (1)

  • d2 test of attention, Karolinska Sleepiness scale, actigraphy, prescribing medication in the EPM system, HRV, urine melatonine, saliva cortisol

    pre call, on call, post call, the second post call day

Eligibility Criteria

Age22 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Surgeons at a surgical unit of gastroenterology in Denmark.

You may qualify if:

  • Surgeons at surgical unit of Gastroenteroloy
  • Men and women between the age of 22-50 years.

You may not qualify if:

  • Pregnancy and breastfeeding
  • Endocrine disease, medically treated
  • Autoimmune disease, medically treated
  • Sleep disturbance, medically treated
  • Intake of alcohol within 24 hours before the study and during the entire study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Copenhagen, Herlev Hospital

Herlev, Herlev, 2730, Denmark

Location

Related Publications (1)

  • Amirian I, Toftegard Andersen L, Rosenberg J, Gogenur I. Decreased heart rate variability in surgeons during night shifts. Can J Surg. 2014 Oct;57(5):300-4. doi: 10.1503/cjs.028813.

    PMID: 25265102DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Urin (melatonine) Saliva (cortisol)

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PHD student at Unit of Surgical Gastroenterology

Study Record Dates

First Submitted

June 18, 2012

First Posted

June 20, 2012

Study Start

December 1, 2011

Primary Completion

March 1, 2012

Study Completion

March 1, 2012

Last Updated

May 21, 2013

Record last verified: 2013-05

Locations

DK(1)