<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03784560</url>
  </required_header>
  <id_info>
    <org_study_id>N-35-2017</org_study_id>
    <nct_id>NCT03784560</nct_id>
  </id_info>
  <brief_title>Effects of Partial Sleep Deprivation on Cognitive Function of Anesthesiologists</brief_title>
  <acronym>sleep</acronym>
  <official_title>Effects of Partial Sleep Deprivation Following Night Shift on Cognitive Functions of Egyptians Anesthesiologists as a Representative of Developing Countries; Prospective Observational Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Cairo University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Cairo University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study was to evaluate differences in cognitive functions at baseline and&#xD;
      following night shift at a trauma center among faculty anesthesiologists.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Anesthesiology is one of the few health-care professions that often demands split-second&#xD;
      decisions. This is especially true in a trauma setting where the situation in the operating&#xD;
      room can change drastically in a few seconds. Anesthesiologists who cover trauma calls&#xD;
      overnight are subject to long work shifts and demanding schedules that may adversely affect&#xD;
      their performance. In combination with the disruption of circadian rhythm that can occur with&#xD;
      night shift work, decline in performance from the long work shifts can lead to errors in&#xD;
      judgment.&#xD;
&#xD;
      An anonymous questionnaire included two groups of different items were used. Items of the&#xD;
      first group are about the personal data i.e. age, sex, marital status and parenting status,&#xD;
      consumption behavior (tea, coffee, carbonated drinks, tobacco, anxiolytics, antidepressants,&#xD;
      psychotropic agents and sport), and professional activity (number of extended worked shifts&#xD;
      per month, number of weekends worked per month).&#xD;
&#xD;
      Items of the second group are related to the night shift itself i.e. number of cases, and the&#xD;
      rest hours during the shift.&#xD;
&#xD;
      Psychomotor Vigilance Task, Karolinska Sleepiness Scale, Epworth Sleepiness Scale and Trail&#xD;
      Making Test before and after the shift were performed.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 2, 2019</start_date>
  <completion_date type="Actual">June 28, 2019</completion_date>
  <primary_completion_date type="Actual">May 28, 2019</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <target_duration>2 Days</target_duration>
  <primary_outcome>
    <measure>The Psychomotor Vigilance Task test</measure>
    <time_frame>24 hours</time_frame>
    <description>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.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Epworth Sleepiness Scale</measure>
    <time_frame>at the beginning of the shift, at the end of 24 shift and at the end of the following working day</time_frame>
    <description>the subjects are asked to rate on a scale from 0 to 3 their usual probability of dozing off in 8 different situations, with 0= &quot;would never doze&quot; and 3 = &quot;a high chance of dozing&quot;. The total ESS score, ranging from 0 to 24, is the sum score of the eight times. Normal day time sleepiness is represented with scores from 0 to 10 detect, while increased levels of excessive daytime sleepiness are represented with scores of 11-24 represent.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Karolinska sleeping scale</measure>
    <time_frame>24 hours</time_frame>
    <description>self-assessed 9-point Likert scale for subjective assessment of the individual's level of drowsiness at a time. It has word descriptors to describe the scale points from 1= &quot;very alert&quot; to 9= &quot;very sleepy, fighting sleep, an effort to keep awake&quot;.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Trail making test</measure>
    <time_frame>24 hours</time_frame>
    <description>The TMT is formed of two parts. In TMT-A, the subject is asked to draw lines sequentially connecting 25 encircled numbers distributed on a paper sheet. In TMT-B except, the subject is asked to alternate between numbers and letters (e.g., 1, A, 2, B, 3, C, etc.). Each part is represented by time in seconds that required to finish the task.</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">50</enrollment>
  <condition>Cognitive Dysfunction</condition>
  <condition>Sleep Deprivation</condition>
  <arm_group>
    <arm_group_label>study group</arm_group_label>
    <description>anesthesia residents with 24 hours working shift</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>The Psychomotor Vigilance Task (PVT)</intervention_name>
    <description>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.</description>
    <arm_group_label>study group</arm_group_label>
    <other_name>PVT</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Epworth Sleepiness Scale</intervention_name>
    <description>Epworth Sleepiness Scale a set of questions that assess excessive daytime sleepiness during professional activities and vacations.&#xD;
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.</description>
    <arm_group_label>study group</arm_group_label>
    <other_name>ESS</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Karolinska sleeping scale</intervention_name>
    <description>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 (&lt;5) may reflect differences in the subjective awareness of fatigue as much, or more than, levels of drowsiness.&#xD;
Higher KSS scores (7+) may refer more specifically to the state of drowsiness because the subject may then have experienced involuntary dozing behavior, with &quot;lapsing&quot; 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</description>
    <arm_group_label>study group</arm_group_label>
    <other_name>KSS</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Trail making test</intervention_name>
    <description>Most variants of this test, which was apparently introduced in 1938 by Partington (Partington &amp; 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.</description>
    <arm_group_label>study group</arm_group_label>
    <other_name>TMT</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Participants included anesthesiologists employed at Kasr El- Ainy Hospital between the ages&#xD;
        of 25-28 years of age and with varying levels of experience.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Full-time faculty anesthesiologists employed at Kasr El- Ainy Hospital.&#xD;
&#xD;
          -  Both genders&#xD;
&#xD;
          -  Ages of 25-28 years.&#xD;
&#xD;
          -  Varying levels of experience.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History of chronic neurological disease.&#xD;
&#xD;
          -  History of psychiatric disorders such as:&#xD;
&#xD;
               -  Episode of major depression within the past 2 years.&#xD;
&#xD;
               -  Lifetime history of schizophrenia.&#xD;
&#xD;
               -  Other psychotic illness or bipolar illness.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>25 Years</minimum_age>
    <maximum_age>30 Years</maximum_age>
  </eligibility>
  <overall_official>
    <last_name>Bassant abdelhamid, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Cairo University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Anesthesia Department</name>
      <address>
        <city>Cairo</city>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>December 2019</verification_date>
  <study_first_submitted>December 16, 2018</study_first_submitted>
  <study_first_submitted_qc>December 19, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 24, 2018</study_first_posted>
  <last_update_submitted>December 2, 2019</last_update_submitted>
  <last_update_submitted_qc>December 2, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">December 3, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Cairo University</investigator_affiliation>
    <investigator_full_name>Bassant M. Abdelhamid</investigator_full_name>
    <investigator_title>associate professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Sleep Deprivation</mesh_term>
    <mesh_term>Cognitive Dysfunction</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03784560
org study id: N-35-2017
nct id: NCT03784560
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
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.
Anesthesiology is one of the few health-care professions that often demands split-second
      decisions. This is especially true in a trauma setting where the situation in the operating
      room can change drastically in a few seconds. Anesthesiologists who cover trauma calls
      overnight are subject to long work shifts and demanding schedules that may adversely affect
      their performance. In combination with the disruption of circadian rhythm that can occur with
      night shift work, decline in performance from the long work shifts can lead to errors in
      judgment.

      An anonymous questionnaire included two groups of different items were used. Items of the
      first group are about the personal data i.e. age, sex, marital status and parenting status,
      consumption behavior (tea, coffee, carbonated drinks, tobacco, anxiolytics, antidepressants,
      psychotropic agents and sport), and professional activity (number of extended worked shifts
      per month, number of weekends worked per month).

      Items of the second group are related to the night shift itself i.e. number of cases, and the
      rest hours during the shift.

      Psychomotor Vigilance Task, Karolinska Sleepiness Scale, Epworth Sleepiness Scale and Trail
      Making Test before and after the shift were performed.
observational model: Cohort
time perspective: Prospective
measure: The Psychomotor Vigilance Task test
time frame: 24 hours
description: 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.
measure: Epworth Sleepiness Scale
time frame: at the beginning of the shift, at the end of 24 shift and at the end of the following working day
description: the subjects are asked to rate on a scale from 0 to 3 their usual probability of dozing off in 8 different situations, with 0= "would never doze" and 3 = "a high chance of dozing". The total ESS score, ranging from 0 to 24, is the sum score of the eight times. Normal day time sleepiness is represented with scores from 0 to 10 detect, while increased levels of excessive daytime sleepiness are represented with scores of 11-24 represent.
measure: Karolinska sleeping scale
time frame: 24 hours
description: self-assessed 9-point Likert scale for subjective assessment of the individual's level of drowsiness at a time. It has word descriptors to describe the scale points from 1= "very alert" to 9= "very sleepy, fighting sleep, an effort to keep awake".
measure: Trail making test
time frame: 24 hours
description: The TMT is formed of two parts. In TMT-A, the subject is asked to draw lines sequentially connecting 25 encircled numbers distributed on a paper sheet. In TMT-B except, the subject is asked to alternate between numbers and letters (e.g., 1, A, 2, B, 3, C, etc.). Each part is represented by time in seconds that required to finish the task.
arm group label: study group
description: anesthesia residents with 24 hours working shift
intervention type: Other
intervention name: The Psychomotor Vigilance Task (PVT)
description: 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.
arm group label: study group
other name: PVT
intervention type: Other
intervention name: Epworth Sleepiness Scale
description: 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.
arm group label: study group
other name: ESS
intervention type: Other
intervention name: Karolinska sleeping scale
description: 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
arm group label: study group
other name: KSS
intervention type: Other
intervention name: Trail making test
description: 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.
arm group label: study group
other name: TMT
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 25 Years
maximum age: 30 Years
last name: Bassant abdelhamid, MD
role: Principal Investigator
affiliation: Cairo University
facility: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Cairo University
investigator full name: Bassant M. Abdelhamid
investigator title: associate professor
mesh term: Sleep Deprivation
mesh term: Cognitive Dysfunction
sharing ipd: Undecided