We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Effect of Naps on Decision Making of Residents.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03225391
Recruitment Status : Completed
First Posted : July 21, 2017
Last Update Posted : July 21, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief 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 phsycians, 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 ocurring in REM sleep. Therefore a nap schedule could improve the decision making of residents during their working hours.

Condition or disease Intervention/treatment
Internship and Residency Sleep Decision Making Behavioral: nap from 0:00 to 3:00 hours Behavioral: nap from 3:00 to 6:00 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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 27 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Investigator)
Masking Description: At the moment of running the Iowa Gambling Task and the Psychomotor Visual Test the investigator does not know the schedule of the nap.
Primary Purpose: Prevention
Official Title: Effect of Programmed Naps on Decision Making of Residents During Working Hours.
Actual Study Start Date : June 10, 2015
Primary Completion Date : February 10, 2016
Study Completion Date : February 10, 2016
Arms and Interventions

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


Outcome Measures

Primary Outcome Measures :
  1. Decision making [ Time Frame: At 12:00 on the day of the nap. ]
    Net total and demographically corrected percentile in the Iowa Gambling Task.


Secondary Outcome Measures :
  1. Alertness [ Time Frame: At 12:00 hours on the day of the nap. ]
    Mean reaction time in the psychomotor vigilance test.

  2. Sleep quality [ Time Frame: 3 hours. ]
    Sleep efficiency as assessed by actigraphy

  3. Vigilance [ Time Frame: At 12:00 hours on the day of the nap. ]
    Slope of the reaction time in the psychomotor vigilance test.

  4. Energy Expenditure [ Time Frame: 22 hours around the nap. ]
    Total activity kcal as calculated via algorithm by actigraphy.

  5. Activity [ Time Frame: 22 hours around the nap. ]
    Percentages of sedentary, light, vigorous and very vigorous activity as calculated via algorithm by actigraphy.


Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   23 Years to 32 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03225391


Locations
Mexico
Insituto Nacional de Enfermedades Respiratorias
Mexico City, Delegacion Tlalpan, Mexico, 14080
Sponsors and Collaborators
Instituto Nacional de Enfermedades Respiratorias
Investigators
Principal Investigator: Armando R Castorena-Maldonado, MD Insituto Nacional de Enfermedades Respiratorias
More Information

Publications:
Responsible Party: Armando Castorena-Maldonado, Head of Otolaryngology Department, Instituto Nacional de Enfermedades Respiratorias
ClinicalTrials.gov Identifier: NCT03225391     History of Changes
Other Study ID Numbers: C05-11
First Posted: July 21, 2017    Key Record Dates
Last Update Posted: July 21, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Armando Castorena-Maldonado, Instituto Nacional de Enfermedades Respiratorias:
Residents
Naps
decision making