Cognitive DysfunctionsleepNCT03784560
Effects of Partial Sleep Deprivation on Cognitive Function of Anesthesiologists
An observational study of Cognitive Dysfunction and Sleep Deprivation, run by Cairo University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 to 30 years
- Conditions the study is for
- Cognitive Dysfunction, Sleep Deprivation
- What is being tested?
- The Psychomotor Vigilance Task (PVT), Epworth Sleepiness Scale and Karolinska sleeping scale
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 2 Jan 2019to 28 Jun 2019
- How long will I take part?
- 2 Days
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 30 years
- All sexes
- Adult
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.
Who may be able to join
- Full-time faculty anesthesiologists employed at Kasr El- Ainy Hospital.
- Both genders
- Ages of 25-28 years.
- Varying levels of experience.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the detailed description
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.
- Conditions
- Cognitive Dysfunction, Sleep Deprivation
- Being tested
- The Psychomotor Vigilance Task (PVT), Epworth Sleepiness Scale, Karolinska sleeping scale, Trail making test
- Medical subject headings
- Cognitive Dysfunction, Sleep Deprivation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The Psychomotor Vigilance Task (PVT)Other
Also called PVT
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.
Epworth Sleepiness ScaleOther
Also called ESS
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.
Karolinska sleeping scaleOther
Also called KSS
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
Trail making testOther
Also called TMT
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.
| Study group | Role | What they receive |
|---|---|---|
| study group | anesthesia residents with 24 hours working shift Receives: Other: The Psychomotor Vigilance Task (PVT); Other: Epworth Sleepiness Scale; Other: Karolinska sleeping scale; Other: Trail making test |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 hours
Secondary outcomes (3)
Epworth Sleepiness Scale
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.
Measured: at the beginning of the shift, at the end of 24 shift and at the end of the following working day
Karolinska sleeping scale
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".
Measured: 24 hours
Trail making test
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.
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2018
- Study start2 Jan 2019
- Primary completion28 May 2019
- Study completion28 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognitive DysfunctionStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
- Target duration
- 2 Days
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bassant M. Abdelhamid, Cairo University
- Investigators
- Bassant abdelhamid, MD, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03784560
- Sponsor's protocol ID
- N-35-2017
- Acronym
- sleep
- Status last verified
- Dec 2019
- First submitted
- 16 Dec 2018
- Last updated
- 3 Dec 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03784560
- Acronym / sponsor ID
- sleep / N-35-2017
- Conditions
- Cognitive Dysfunction, Sleep Deprivation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 2 Jan 2019 (actual)
- Primary completion
- 28 May 2019 (actual)
- Study completion
- 28 Jun 2019 (actual)
- First posted
- 24 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Days
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| study group | – | Other: The Psychomotor Vigilance Task (PVT), Other: Epworth Sleepiness Scale, Other: Karolinska sleeping scale, Other: Trail making testanesthesia residents with 24 hours working shift |
Who may qualify
- Ages
- 25 to 30 years
- Sex
- All
- Age groups
- Adult
- 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.
Key inclusion criteria (4 listed)
- Full-time faculty anesthesiologists employed at Kasr El- Ainy Hospital.
- Both genders
- Ages of 25-28 years.
- Varying levels of experience.
Key exclusion criteria (5 listed)
- History of chronic neurological disease.
- History of psychiatric disorders such as:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| The Psychomotor Vigilance Task (PVT)Also: PVTPVT 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. | Other | study group |
| Epworth Sleepiness ScaleAlso: ESSEpworth 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. | Other | study group |
| Karolinska sleeping scaleAlso: KSSThe 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 | Other | study group |
| Trail making testAlso: TMTMost 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. | Other | study group |
Primary outcome
The Psychomotor Vigilance Task test
Time frame: 24 hours
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.
3 secondary outcomes
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
Karolinska sleeping scale
Time frame: 24 hours
Trail making test
Time frame: 24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2019.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bassant abdelhamid, MD principal investigator
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cognitive Dysfunction and Sleep Deprivation, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Psychomotor Vigilance Task test (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Dec 2019.