- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03225391
Effect of Naps on Decision Making of Residents.
Effect of Programmed Naps on Decision Making of Residents During Working Hours.
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
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Delegacion Tlalpan
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Mexico City, Delegacion Tlalpan, Mexico, 14080
- Insituto Nacional de Enfermedades Respiratorias
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- Chronic-degenerative or psychiatric disease.
- Sleep disorders diagnosed before recruiting.
Elimination Criteria:
- Not performing all psychometric tests.
- Lack of data in questionnaire.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Nap 1
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.
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A nap from 0:00 to 3:00 hours during a night shift.
A nap from 3:00 to 6:00 hours during a night shift.
|
Experimental: Nap 2
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.
|
A nap from 0:00 to 3:00 hours during a night shift.
A nap from 3:00 to 6:00 hours during a night shift.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Decision making
Time Frame: At 12:00 on the day of the nap.
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Net total and demographically corrected percentile in the Iowa Gambling Task.
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At 12:00 on the day of the nap.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Alertness
Time Frame: At 12:00 hours on the day of the nap.
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Mean reaction time in the psychomotor vigilance test.
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At 12:00 hours on the day of the nap.
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Sleep quality
Time Frame: 3 hours.
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Sleep efficiency as assessed by actigraphy
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3 hours.
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Vigilance
Time Frame: At 12:00 hours on the day of the nap.
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Slope of the reaction time in the psychomotor vigilance test.
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At 12:00 hours on the day of the nap.
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Energy Expenditure
Time Frame: 22 hours around the nap.
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Total activity kcal as calculated via algorithm by actigraphy.
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22 hours around the nap.
|
Activity
Time Frame: 22 hours around the nap.
|
Percentages of sedentary, light, vigorous and very vigorous activity as calculated via algorithm by actigraphy.
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22 hours around the nap.
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Collaborators and Investigators
Investigators
- Principal Investigator: Armando R Castorena-Maldonado, MD, Insituto Nacional de Enfermedades Respiratorias
Publications and helpful links
General 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.
- Rollinson 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.
- Schweitzer 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.
- Killgore 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.
- Mednick 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- C05-11
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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