NCT03225391

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 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
27

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 10, 2015

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

July 19, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 21, 2017

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 10, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 10, 2019

Completed
Last Updated

February 19, 2020

Status Verified

February 1, 2020

Enrollment Period

4.5 years

First QC Date

July 19, 2017

Last Update Submit

February 17, 2020

Conditions

Internship and ResidencySleepDecision Making

Keywords

ResidentsNapsdecision making

Outcome Measures

Primary Outcomes (1)

  • Decision making

    Net total and demographically corrected percentile in the Iowa Gambling Task.

    At 12:00 on the day of the nap.

Secondary Outcomes (5)

  • Alertness

    At 12:00 hours on the day of the nap.

  • Sleep quality

    3 hours.

  • Vigilance

    At 12:00 hours on the day of the nap.

  • Energy Expenditure

    22 hours around the nap.

  • Activity

    22 hours around the nap.

Study Arms (2)

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.

Behavioral: nap from 0:00 to 3:00 hoursBehavioral: 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.

Behavioral: nap from 0:00 to 3:00 hoursBehavioral: nap from 3:00 to 6:00 hours

Interventions

nap from 0:00 to 3:00 hoursBEHAVIORAL

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

Nap 1Nap 2
nap from 3:00 to 6:00 hoursBEHAVIORAL

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

Nap 1Nap 2

Eligibility Criteria

Age23 Years - 32 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • Chronic-degenerative or psychiatric disease.
  • Sleep disorders diagnosed before recruiting.
  • Elimination Criteria:
  • Not performing all psychometric tests.
  • Lack of data in questionnaire.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Insituto Nacional de Enfermedades Respiratorias

Mexico City, Delegacion Tlalpan, 14080, Mexico

Location

Related 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. doi: 10.1067/mob.2003.306.

    PMID: 12748477BACKGROUND

  • 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.

    PMID: 12605209BACKGROUND

  • 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.

    PMID: 16453980BACKGROUND

  • 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.

    PMID: 16489997BACKGROUND

  • 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.

    PMID: 12032542BACKGROUND

Study Officials

  • Armando R Castorena-Maldonado, MD

    Insituto Nacional de Enfermedades Respiratorias

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Masking Details
At the moment of running the Iowa Gambling Task and the Psychomotor Visual Test the investigator does not know the schedule of the nap.
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Otolaryngology Department

Study Record Dates

First Submitted

July 19, 2017

First Posted

July 21, 2017

Study Start

June 10, 2015

Primary Completion

December 10, 2019

Study Completion

December 10, 2019

Last Updated

February 19, 2020

Record last verified: 2020-02

Locations

ME(1)