Effect of Sleep DeprivationNCT01623674
Laparoscopic Skills and Cognitive Function Are Not Affected by Night Shifts in Surgeons
An observational study of Effect of Sleep Deprivation, run by Herlev Hospital at 1 site in Denmark.
Trial 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… Read more about this study
- Who is it for?
- Ages 22 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Effect of Sleep Deprivation
- How many people
- 30 participants
- Where
- 1 siteDenmark
- Study dates
- Dec 2011to Mar 2012
- 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 22 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Surgeons at a surgical unit of gastroenterology in Denmark.
Who may be able to join
- Surgeons at surgical unit of Gastroenteroloy
- Men and women between the age of 22-50 years.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
The surgeons wore an actigraph consecutively on all 4 days, and would fill out a sleep diary on all 4 days as well. The surgeons were heart monitored consecutively on day 1 and 2.
The surgeons were tested in a laparoscopic simulator at 8 a.m. day 1, 4 a.m. day 2, and again at 8 a.m. day 4. At the same given times they would perform the d2 test of attention and prescribe medicine in the Electronic Patient Medication system in accordance with a case they were given. Furthermore they delivered a salivary sample for the determination of salivary cortisol, at the given times.
They sampled urine from 9 pm - 9 am all 4 days, in order to measure the production of melatonin in urine.
The surgeons would fill out the Karolinska sleepiness scale, VAS (Visual Analog Scale) fatigue, VAS sleep quality and VAS general well being at 8 a.m. day 1, 4 a.m. day 2, and again at 8 a.m. day 4. The Karolinska Sleepiness scale was filled out every second hour on day 2 from 4pm - 8 am on day 3.
- Conditions
- Effect of Sleep Deprivation
- Keywords
- Sleep deprivation in surgeons during night shifts and the effect on performance.
What is being measured
The primary outcome is the main question the study is designed to answer.
laparoscopic simulation
Measured: 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
Measured: pre call, on call, post call, the second post call day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2012 (estimated)
- Study startDec 2011
- Primary completionMar 2012
- Study completionMar 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Effect of Sleep DeprivationStudies of the same condition, open and under way.
- 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
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Herlev Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- TRYG Foundation, Danish Medical Association
- Responsible party
- Principal investigator, Ilda Amirian, Herlev Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01623674
- Sponsor's protocol ID
- Herlev-12345
- Status last verified
- May 2013
- First submitted
- 18 Jun 2012
- Last updated
- 21 May 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 25265102
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Laparoscopic Skills and Cognitive Function Are Not Affected by Night Shifts in Surgeons
- ClinicalTrials.gov ID
- NCT01623674
- Acronym / sponsor ID
- Herlev-12345
- Conditions
- Effect of Sleep Deprivation
- Keywords
- Sleep deprivation in surgeons during night shifts and the effect on performance.
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Herlev HospitalUniversity, hospital or other
- Collaborators
- TRYG Foundation, Danish Medical Association
- Study start
- Dec 2011
- Primary completion
- Mar 2012 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 20 Jun 2012 (estimated)
- 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.
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.
Detailed description
The surgeons wore an actigraph consecutively on all 4 days, and would fill out a sleep diary on all 4 days as well. The surgeons were heart monitored consecutively on day 1 and 2.
The surgeons were tested in a laparoscopic simulator at 8 a.m. day 1, 4 a.m. day 2, and again at 8 a.m. day 4. At the same given times they would perform the d2 test of attention and prescribe medicine in the Electronic Patient Medication system in accordance with a case they were given. Furthermore they delivered a salivary sample for the determination of salivary cortisol, at the given times.
They sampled urine from 9 pm - 9 am all 4 days, in order to measure the production of melatonin in urine.
The surgeons would fill out the Karolinska sleepiness scale, VAS (Visual Analog Scale) fatigue, VAS sleep quality and VAS general well being at 8 a.m. day 1, 4 a.m. day 2, and again at 8 a.m. day 4. The Karolinska Sleepiness scale was filled out every second hour on day 2 from 4pm - 8 am on day 3.
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 22 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Surgeons at a surgical unit of gastroenterology in Denmark.
Key inclusion criteria (2 listed)
- Surgeons at surgical unit of Gastroenteroloy
- Men and women between the age of 22-50 years.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
laparoscopic simulation
Time frame: pre call and on call
1 secondary outcome
d2 test of attention, Karolinska Sleepiness scale, actigraphy, prescribing medication in the EPM system, HRV, urine melatonine, saliva cortisol
Time frame: pre call, on call, post call, the second post call day
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 21 May 2013.
- Derived from this study: PubMed 25265102Amirian 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.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Effect of Sleep Deprivation, run by Herlev Hospital at 1 site in Denmark.
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 2 inclusion and 5 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 21 May 2013. 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 Denmark. 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?
laparoscopic simulation (time frame: pre call and on call). 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 NCT01623674, which also lists 1 linked publication.
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 21 May 2013.