Internship and ResidencyNCT03225391
Effect of Naps on Decision Making of Residents.
A study testing nap from 0:00 to 3:00 hours and nap from 3:00 to 6:00 hours in people with Internship and Residency and Sleep, run by Instituto Nacional de Enfermedades Respiratorias at 1 site in Mexico.
Trial summary
Sleep deprivation produces changes including alteration of mood, irritability, fatigue, less focus and disorientation, also perceptive distortions, visual hallucinations and considering tasks harder and less pleasant. In resident physicians, these alterations have been shown to affect their work performance. Read more about this study
- Who is it for?
- Ages 23 to 32 years
- Conditions the study is for
- Internship and Residency, Sleep, Decision Making
- What is being tested?
- nap from 0:00 to 3:00 hours and nap from 3:00 to 6:00 hours
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteMexico
- Study dates
- 10 Jun 2015to 10 Dec 2019
- Phase
- Interventional
- 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 23 to 32 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Resident physician cursing the first to third year in the pulmonology or pediatric pulmonology residency of the INER.
- Accepts to participate in the study signing the informed consent.
Who cannot join
- Chronic-degenerative or psychiatric disease.
- Sleep disorders diagnosed before recruiting.
- Elimination Criteria:
- Not performing all psychometric tests.
- Lack of data in questionnaire.
Trial locations and contacts
1 site in 1 country.
Mexico1 site
Insituto Nacional de Enfermedades Respiratorias
Mexico City, Delegacion Tlalpan, 14080
About this study
Official title: Effect of Programmed Naps on Decision Making of Residents During Working Hours.
Sleep deprivation produces changes including alteration of mood, irritability, fatigue, less focus and disorientation, also perceptive distortions, visual hallucinations and considering tasks harder and less pleasant. In resident physicians, these alterations have been shown to affect their work performance. Naps have proved to improve arousal and attention, alertness and performance. Those longer than 90 minutes promote a learning process similar to that occurring in REM sleep. Therefore a nap schedule could improve the decision making of residents during their working hours.
Read the detailed description
Sleep deprivation produces changes including alteration of mood, irritability, fatigue, less focus and disorientation, also perceptive distortions, visual hallucinations and considering tasks harder and less pleasant. Extenuating working hours provoke sleep deprivation, which deteriorates work performance, produces mood disorders and increase chances of error.
In a survey performed to 3600 resident physicians in the USA it was observed that working more than 24 continuous hours was related with a higher risk of traffic accidents, as well as a higher tendency towards medical mistakes due to overstress, the most common being a diminished capability of performing a previously known procedure; also there were difficulties to solve problems generated by coworkers or relatives. Other study determinated that after a night shift the levels of daytime sleepiness were similar or higher than those of patients with narcolepsy or sleep apnea. The lack of sleep affects the performance of tasks, producing alterations similar to those in alcoholic intoxication, with a decline in visual attention, reaction speed, visual memory and creative thinking. Even though the effects of sleep deprivation in resident have been difficult to quantify due to confounders, there are indicators as decline in performance, which seems higher in less experienced physicians, with a higher alteration in reasoning and reaction time. It has been found in physicians in training (anesthesiology residents) that mistakes in administration of epidural anesthesia are more frequent after sleep deprivation; and a resident performing monitoring tasks after a night shift was more liable to mistakes that after a resting night, being also less likely to recognize arrhythmias in an electrocardiogram. Sleep deprivation affects coordination and skill, as observed in laparoscopist surgeons who took more time to complete a procedure after sleep deprivation than those who had rested. This results made the ACGME to establish a limitation in working hours during the residence.
Naps from 30 minutes to 4 hours improve alertness and performance. Studies comparing naps and caffeine have shown that naps not only improve arousal and attention but also helps to consolidate memory in those longer than 90 minutes. Furthermore, naps with slow wave and REM sleep are partially equivalent to a night's sleep, restoring the damage from baseline. It has been proven that naps promote a learning process similar to that occurring in a complete night sleep, which correlates with phase 2 of REM sleep. Therefore a nap schedule could improve the decision making of residents during their working hours.
- Conditions
- Internship and Residency, Sleep, Decision Making
- Being tested
- nap from 0:00 to 3:00 hours, nap from 3:00 to 6:00 hours
- Keywords
- Residents, Naps, decision making
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nap from 0:00 to 3:00 hoursBehavioural
A nap from 0:00 to 3:00 hours during a night shift.
nap from 3:00 to 6:00 hoursBehavioural
A nap from 3:00 to 6:00 hours during a night shift.
| Study group | Role | What they receive |
|---|---|---|
| Nap 1 | Experimental | Subjects who take, during a night shift, first a nap from 0:00 to 3:00 hours and, after 6 weeks of lavage, another nap from 3:00 to 6:00 hours. Receives: Behavioral: nap from 0:00 to 3:00 hours; Behavioral: nap from 3:00 to 6:00 hours |
| Nap 2 | Experimental | Subjects who take, during a night shift, first a nap from 3:00 to 6:00 hours and, after 6 weeks of lavage, another nap from 0:00 to 3:00 hours. Receives: Behavioral: nap from 0:00 to 3:00 hours; Behavioral: nap from 3:00 to 6:00 hours |
What is being measured
The primary outcome is the main question the study is designed to answer.
Decision making
Net total and demographically corrected percentile in the Iowa Gambling Task.
Measured: At 12:00 on the day of the nap.
Secondary outcomes (5)
Alertness
Mean reaction time in the psychomotor vigilance test.
Measured: At 12:00 hours on the day of the nap.
Sleep quality
Sleep efficiency as assessed by actigraphy
Measured: 3 hours.
Vigilance
Slope of the reaction time in the psychomotor vigilance test.
Measured: At 12:00 hours on the day of the nap.
Energy Expenditure
Total activity kcal as calculated via algorithm by actigraphy.
Measured: 22 hours around the nap.
Activity
Percentages of sedentary, light, vigorous and very vigorous activity as calculated via algorithm by actigraphy.
Measured: 22 hours around the nap.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2017
- Study start10 Jun 2015
- Primary completion10 Dec 2019
- Study completion10 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Internship and ResidencyStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto Nacional de Enfermedades Respiratorias
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Armando Castorena-Maldonado, Instituto Nacional de Enfermedades Respiratorias
- Investigators
- Armando R Castorena-Maldonado, MD, Principal investigator, Insituto Nacional de Enfermedades Respiratorias
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03225391
- Sponsor's protocol ID
- C05-11
- Status last verified
- Feb 2020
- First submitted
- 19 Jul 2017
- Last updated
- 19 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Halbach MM, Spann CO, Egan G. Effect of sleep deprivation on medical resident and student cognitive function: A prospective study. Am J Obstet Gynecol. 2003 May;188(5):1198-201. doi: 10.1067/mob.2003.306.
PubMed 12748477Rollinson DC, Rathlev NK, Moss M, Killiany R, Sassower KC, Auerbach S, Fish SS. The effects of consecutive night shifts on neuropsychological performance of interns in the emergency department: a pilot study. Ann Emerg Med. 2003 Mar;41(3):400-6. doi: 10.1067/mem.2003.77.
PubMed 12605209Schweitzer PK, Randazzo AC, Stone K, Erman M, Walsh JK. Laboratory and field studies of naps and caffeine as practical countermeasures for sleep-wake problems associated with night work. Sleep. 2006 Jan;29(1):39-50. doi: 10.1093/sleep/29.1.39.
PubMed 16453980Killgore WD, Balkin TJ, Wesensten NJ. Impaired decision making following 49 h of sleep deprivation. J Sleep Res. 2006 Mar;15(1):7-13. doi: 10.1111/j.1365-2869.2006.00487.x.
PubMed 16489997Mednick SC, Nakayama K, Cantero JL, Atienza M, Levin AA, Pathak N, Stickgold R. The restorative effect of naps on perceptual deterioration. Nat Neurosci. 2002 Jul;5(7):677-81. doi: 10.1038/nn864.
PubMed 12032542
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Programmed Naps on Decision Making of Residents During Working Hours.
- ClinicalTrials.gov ID
- NCT03225391
- Acronym / sponsor ID
- C05-11
- Conditions
- Internship and Residency, Sleep, Decision Making
- Keywords
- Residents, Naps, decision making
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Instituto Nacional de Enfermedades RespiratoriasOther government
- Study start
- 10 Jun 2015 (actual)
- Primary completion
- 10 Dec 2019 (actual)
- Study completion
- 10 Dec 2019 (actual)
- First posted
- 21 Jul 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.
Sleep deprivation produces changes including alteration of mood, irritability, fatigue, less focus and disorientation, also perceptive distortions, visual hallucinations and considering tasks harder and less pleasant. In resident physicians, these alterations have been shown to affect their work performance. Naps have proved to improve arousal and attention, alertness and performance. Those longer than 90 minutes promote a learning process similar to that occurring in REM sleep. Therefore a nap schedule could improve the decision making of residents during their working hours.
Detailed description
Sleep deprivation produces changes including alteration of mood, irritability, fatigue, less focus and disorientation, also perceptive distortions, visual hallucinations and considering tasks harder and less pleasant. Extenuating working hours provoke sleep deprivation, which deteriorates work performance, produces mood disorders and increase chances of error.
In a survey performed to 3600 resident physicians in the USA it was observed that working more than 24 continuous hours was related with a higher risk of traffic accidents, as well as a higher tendency towards medical mistakes due to overstress, the most common being a diminished capability of performing a previously known procedure; also there were difficulties to solve problems generated by coworkers or relatives. Other study determinated that after a night shift the levels of daytime sleepiness were similar or higher than those of patients with narcolepsy or sleep apnea. The lack of sleep affects the performance of tasks, producing alterations similar to those in alcoholic intoxication, with a decline in visual attention, reaction speed, visual memory and creative thinking. Even though the effects of sleep deprivation in resident have been difficult to quantify due to confounders, there are indicators as decline in performance, which seems higher in less experienced physicians, with a higher alteration in reasoning and reaction time. It has been found in physicians in training (anesthesiology residents) that mistakes in administration of epidural anesthesia are more frequent after sleep deprivation; and a resident performing monitoring tasks after a night shift was more liable to mistakes that after a resting night, being also less likely to recognize arrhythmias in an electrocardiogram. Sleep deprivation affects coordination and skill, as observed in laparoscopist surgeons who took more time to complete a procedure after sleep deprivation than those who had rested. This results made the ACGME to establish a limitation in working hours during the residence.
Naps from 30 minutes to 4 hours improve alertness and performance. Studies comparing naps and caffeine have shown that naps not only improve arousal and attention but also helps to consolidate memory in those longer than 90 minutes. Furthermore, naps with slow wave and REM sleep are partially equivalent to a night's sleep, restoring the damage from baseline. It has been proven that naps promote a learning process similar to that occurring in a complete night sleep, which correlates with phase 2 of REM sleep. Therefore a nap schedule could improve the decision making of residents during their working hours.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nap 1 | Experimental | Behavioral: nap from 0:00 to 3:00 hours, Behavioral: nap from 3:00 to 6:00 hoursSubjects who take, during a night shift, first a nap from 0:00 to 3:00 hours and, after 6 weeks of lavage, another nap from 3:00 to 6:00 hours. |
| Nap 2 | Experimental | Behavioral: nap from 0:00 to 3:00 hours, Behavioral: nap from 3:00 to 6:00 hoursSubjects who take, during a night shift, first a nap from 3:00 to 6:00 hours and, after 6 weeks of lavage, another nap from 0:00 to 3:00 hours. |
Who may qualify
- Ages
- 23 to 32 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Resident physician cursing the first to third year in the pulmonology or pediatric pulmonology residency of the INER.
- Accepts to participate in the study signing the informed consent.
Key exclusion criteria (5 listed)
- Chronic-degenerative or psychiatric disease.
- Sleep disorders diagnosed before recruiting.
- Not performing all psychometric tests.
- Lack of data in questionnaire.
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 |
|---|---|---|
| nap from 0:00 to 3:00 hoursA nap from 0:00 to 3:00 hours during a night shift. | Behavioural | Nap 1, Nap 2 |
| nap from 3:00 to 6:00 hoursA nap from 3:00 to 6:00 hours during a night shift. | Behavioural | Nap 1, Nap 2 |
Primary outcome
Decision making
Time frame: At 12:00 on the day of the nap.
Net total and demographically corrected percentile in the Iowa Gambling Task.
5 secondary outcomes
Alertness
Time frame: At 12:00 hours on the day of the nap.
Sleep quality
Time frame: 3 hours.
Vigilance
Time frame: At 12:00 hours on the day of the nap.
Energy Expenditure
Time frame: 22 hours around the nap.
Activity
Time frame: 22 hours around the nap.
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 19 Feb 2020.
- Background: PubMed 12748477Halbach MM, Spann CO, Egan G. Effect of sleep deprivation on medical resident and student cognitive function: A prospective study. Am J Obstet Gynecol. 2003 May;188(5):1198-201. doi: 10.1067/mob.2003.306.
- Background: PubMed 12605209Rollinson DC, Rathlev NK, Moss M, Killiany R, Sassower KC, Auerbach S, Fish SS. The effects of consecutive night shifts on neuropsychological performance of interns in the emergency department: a pilot study. Ann Emerg Med. 2003 Mar;41(3):400-6. doi: 10.1067/mem.2003.77.
- Background: PubMed 16453980Schweitzer PK, Randazzo AC, Stone K, Erman M, Walsh JK. Laboratory and field studies of naps and caffeine as practical countermeasures for sleep-wake problems associated with night work. Sleep. 2006 Jan;29(1):39-50. doi: 10.1093/sleep/29.1.39.
- Background: PubMed 16489997Killgore WD, Balkin TJ, Wesensten NJ. Impaired decision making following 49 h of sleep deprivation. J Sleep Res. 2006 Mar;15(1):7-13. doi: 10.1111/j.1365-2869.2006.00487.x.
- Background: PubMed 12032542Mednick SC, Nakayama K, Cantero JL, Atienza M, Levin AA, Pathak N, Stickgold R. The restorative effect of naps on perceptual deterioration. Nat Neurosci. 2002 Jul;5(7):677-81. doi: 10.1038/nn864.
- Individual participant dataSharing planned: Undecided
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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.
Armando R Castorena-Maldonado, MD principal investigator
Insituto Nacional de Enfermedades Respiratorias
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing nap from 0:00 to 3:00 hours and nap from 3:00 to 6:00 hours in people with Internship and Residency and Sleep, run by Instituto Nacional de Enfermedades Respiratorias at 1 site in Mexico.
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 19 Feb 2020. 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 Mexico. 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?
Decision making (time frame: At 12:00 on the day of the nap.). 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 NCT03225391, which also lists 5 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 19 Feb 2020.