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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03225391
Other study ID # C05-11
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date June 10, 2015
Est. completion date December 10, 2019

Study information

Verified date February 2020
Source Instituto Nacional de Enfermedades Respiratorias
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 27
Est. completion date December 10, 2019
Est. primary completion date December 10, 2019
Accepts healthy volunteers No
Gender All
Age group 23 Years to 32 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Behavioral:
nap from 0:00 to 3:00 hours
A nap from 0:00 to 3:00 hours during a night shift.
nap from 3:00 to 6:00 hours
A nap from 3:00 to 6:00 hours during a night shift.

Locations

Country Name City State
Mexico Insituto Nacional de Enfermedades Respiratorias Mexico City Delegacion Tlalpan

Sponsors (1)

Lead Sponsor Collaborator
Instituto Nacional de Enfermedades Respiratorias

Country where clinical trial is conducted

Mexico, 

References & Publications (5)

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. — View Citation

Killgore WD, Balkin TJ, Wesensten NJ. Impaired decision making following 49 h of sleep deprivation. J Sleep Res. 2006 Mar;15(1):7-13. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Decision making Net total and demographically corrected percentile in the Iowa Gambling Task. At 12:00 on the day of the nap.
Secondary Alertness Mean reaction time in the psychomotor vigilance test. At 12:00 hours on the day of the nap.
Secondary Sleep quality Sleep efficiency as assessed by actigraphy 3 hours.
Secondary Vigilance Slope of the reaction time in the psychomotor vigilance test. At 12:00 hours on the day of the nap.
Secondary Energy Expenditure Total activity kcal as calculated via algorithm by actigraphy. 22 hours around the nap.
Secondary Activity Percentages of sedentary, light, vigorous and very vigorous activity as calculated via algorithm by actigraphy. 22 hours around the nap.
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