NCT03784560

Brief Summary

The purpose of this study was to evaluate differences in cognitive functions at baseline and following night shift at a trauma center among faculty anesthesiologists.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2019

Shorter than P25 for all trials

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

First Submitted

Initial submission to the registry

December 16, 2018

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 24, 2018

Completed
9 days until next milestone

Study Start

First participant enrolled

January 2, 2019

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 28, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 28, 2019

Completed
Last Updated

December 3, 2019

Status Verified

December 1, 2019

Enrollment Period

5 months

First QC Date

December 16, 2018

Last Update Submit

December 2, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • The Psychomotor Vigilance Task test

    the participant presses a response button as soon as a visual stimulus appears on the screen. There is standard version of the PVT with duration of 10 min. The shorter version, PVT brief, with duration of 3 minutes have been used in the current study using PEBL 2 software computer program and reaction times (RTs) were displayed to the study participants in milliseconds.

    24 hours

Secondary Outcomes (3)

  • Epworth Sleepiness Scale

    at the beginning of the shift, at the end of 24 shift and at the end of the following working day

  • Karolinska sleeping scale

    24 hours

  • Trail making test

    24 hours

Study Arms (1)

study group

anesthesia residents with 24 hours working shift

Other: The Psychomotor Vigilance Task (PVT)Other: Epworth Sleepiness ScaleOther: Karolinska sleeping scaleOther: Trail making test

Interventions

PVT has emerged as one of the most widely used tools to assess vigilant attention. Vigilance can be defined as sustained attention and tonic alertness. In sleep deprived individuals, vigilance is the component of cognition that is most consistently and dramatically affected. The PVT is a reaction-time test that allows the collection of a large amount of data in a relatively short period of time. These characteristics increase the sensitivity of the test to detect even small changes in vigilant attention, which can wax and wane within seconds.

Also known as: PVT
study group

Epworth Sleepiness Scale a set of questions that assess excessive daytime sleepiness during professional activities and vacations. This scale was designed to assess the efficiency of sleep apnea treatments. It is also used for the subjective sleepiness assessment based on the likelihood of falling asleep in different everyday life situations. This results in an overall score.

Also known as: ESS
study group

The KSS is assumed to be an ordinal scale with a unitary structure. KSS scores may require standardization to control for differences between subjects. The changes observed in the EEG/EOG with drowsiness do not usually appear until KSS scores reach 7 and higher. Lower KSS scores (\<5) may reflect differences in the subjective awareness of fatigue as much, or more than, levels of drowsiness. Higher KSS scores (7+) may refer more specifically to the state of drowsiness because the subject may then have experienced involuntary dozing behavior, with "lapsing" episodes and brief loss of awareness of the here-and-now, followed by arousal and the return of awareness, including some awareness of recently having dozed off

Also known as: KSS
study group

Most variants of this test, which was apparently introduced in 1938 by Partington (Partington \& Leiter, 1949), have at least two conditions. In condition A the participant is to draw lines to connect circled numbers in a numerical sequence (i.e., 1-2-3, etc.) as rapidly as possible. In condition B the participant is to draw lines to connect circled numbers and letters in an alternating numeric and alphabetic sequence (i.e., 1-A-2-B, etc.) as rapidly as possible.

Also known as: TMT
study group

Eligibility Criteria

Age25 Years - 30 Years
Sexall
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Participants included anesthesiologists employed at Kasr El- Ainy Hospital between the ages of 25-28 years of age and with varying levels of experience.

You may qualify if:

  • Full-time faculty anesthesiologists employed at Kasr El- Ainy Hospital.
  • Both genders
  • Ages of 25-28 years.
  • Varying levels of experience.

You may not qualify if:

  • History of chronic neurological disease.
  • History of psychiatric disorders such as:
  • Episode of major depression within the past 2 years.
  • Lifetime history of schizophrenia.
  • Other psychotic illness or bipolar illness.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Anesthesia Department

Cairo, Egypt

Location

MeSH Terms

Conditions

Cognitive DysfunctionSleep Deprivation

Interventions

Trail Making Test

Condition Hierarchy (Ancestors)

Cognition DisordersNeurocognitive DisordersMental DisordersDyssomniasSleep Wake DisordersNervous System DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Neuropsychological TestsPsychological TestsBehavioral Disciplines and Activities

Study Officials

  • Bassant abdelhamid, MD

    Cairo University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
2 Days
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
associate professor

Study Record Dates

First Submitted

December 16, 2018

First Posted

December 24, 2018

Study Start

January 2, 2019

Primary Completion

May 28, 2019

Study Completion

June 28, 2019

Last Updated

December 3, 2019

Record last verified: 2019-12

Locations