Sleep DeprivationNCT02697266
The Effects of Night Call on Intellectual Performance
An observational study of Sleep Deprivation, run by Haleh Saadat at 1 site in United States.
Trial summary
The purpose of the current proposal will be to examine the clinical performance of both physicians in training as well as experienced faculty in pre and post call situations. Groups will be matched for gender, age, experience and employment duration during regular hours versus immediate post call hour. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Sleep Deprivation
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2014to Sep 2016
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Twenty-four attending anesthesiologists and anesthesiology residents
Who may be able to join
- Staff Attending Anesthesiologist who takes night shift call
- Anesthesiology residents who take night shift call
Who cannot join
- Staff unwilling to participate
Trial locations and contacts
1 site in 1 country.
United States1 site
Nationwide Children's Hospital
Columbus, Ohio, 43205
About this study
Official title: Individual Coping Strategies After Night Calls: Effects on Performing Clinical and Cognitive Tasks
The purpose of the current proposal will be to examine the clinical performance of both physicians in training as well as experienced faculty in pre and post call situations. Groups will be matched for gender, age, experience and employment duration during regular hours versus immediate post call hour.
Read the detailed description
This is a prospective study evaluating the reaction time among attending anesthesiologists, and anesthesiology residents who take night shift call and are suffering from sleep deprivation. Investigators plan to examine clinical performance by measuring reaction times using a 10 minute psychomotor vigilance test device on physicians in training as well as experienced physicians in pre and post call situations.
All subjects will be informed of the scope and purpose of the study.
- Attending Anesthesiologists: Gender, age, years of experience, years of employment at the institution, hours of sleep and circadian rhythm will be taken into effect.
- Residents/Fellows: Gender, age, years of experience, years of employment at the institution and circadian rhythm will be taken into effect.
All study subjects will be asked to fill a questionnaire regarding demographic data, coping strategy Index.
- Baseline instruments; including demographics, and coping strategy indicator (CSI), will be administrated.
- Reaction time, mood and simple cognitive test will be measured at approximately 7 am of a regular day, (when the subject is not on call).
- Reaction time, mood and simple cognitive test will be measured at approximately 7 am of after a call night.
This proposal attempts to examine the impact of night shift on mood, cognitive and motor task performance in physicians as compared to regular hours.
- Conditions
- Sleep Deprivation
- Being tested
- No intervention
- Medical subject headings
- Sleep Deprivation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
This is an observational study.
| Study group | Role | What they receive |
|---|---|---|
| Post-call anesthesiologists | Attending anesthesiologists, and Anesthesiology residents Receives: Other: No intervention | |
| Regular-shift anesthesiologists | Attending anesthesiologists, and Anesthesiology residents Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reaction time
We plan to measure reaction times via a 10-minute psychomotor vigilance test (PVT, Ambulatory Monitoring Inc., NY) device. The PVT-192 Psychomotor Vigilance Task Monitor is a hand-held, self-contained system used for repetitive reaction time measurements.
Measured: Regular Day and Post-call shifts - Through study completion, an average of one year.
Visual Analog Scale
Subjective sleepiness and alertness (and other parameters) will be measured via the Visual Analog Scale (VAS). This Questionnaire consists of several 100 millimeter lines, each of which is labeled at one end with the words "not at all" and the other end with the word "extremely". Centered under each line are the test adjectives which are as follows: "alert, able to concentrate, " anxious", "energetic", "feel confident", "irritable", "Jittery/nervous", "sleepy", and "talkative". The participants indicate the point on the line, which corresponded to the way they feel along the continuum at the time the test is taken. The score for each item consists of a number of millimeters from the left side of the line to the location at which the participants placed their mark.
Measured: Regular Day and Post-call shifts - Through study completion, an average of one year.
Profile of mood states
Subjective evaluations of mood will be made with the Profile of Mood States (POMS). The POMS is a 65-Item questionnaire which, when scored according to the specific templates, measures affect or mood on scales: 1) Tension-Anxiety, 2) Depression-dejection, 3) anger-hostility, 4) vigor-activity, 5) fatigue-inertia, and 6) confusion-bewilderment. Factor scores on each scale will be analyzed.
Measured: Regular Day and Post-call shifts - Through study completion, an average of one year.
Secondary outcomes (1)
Coping Strategy Indicator (CSI):
This is the self-report measure of three fundamental modes of coping that has demonstrated considerable psychometric strength. The CSI first instructs responders to select a recent stressful event from their lives and briefly describe it. Then, responders read a list of 33 specific coping behaviors, indicating the extent to which each was used to deal with the problem. Responders are summed to form three scales: problem solving, seeking social support and avoidance.
Measured: Regular-shift - Through study completion, an average of one year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2016 (estimated)
- Study startMar 2014
- Primary completionApr 2016
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep DeprivationStudies of the same condition, open and under way.
- 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
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Haleh Saadat
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Haleh Saadat, Nationwide Children's Hospital
- Investigators
- Haleh Saadat, MD, Principal investigator, Nationwide Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02697266
- Sponsor's protocol ID
- IRB14-00143
- Status last verified
- Sep 2016
- First submitted
- 21 Dec 2015
- Last updated
- 9 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Individual Coping Strategies After Night Calls: Effects on Performing Clinical and Cognitive Tasks
- ClinicalTrials.gov ID
- NCT02697266
- Acronym / sponsor ID
- IRB14-00143
- Conditions
- Sleep Deprivation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Haleh SaadatUniversity, hospital or other
- Study start
- Mar 2014
- Primary completion
- Apr 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 3 Mar 2016 (estimated)
- 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 the current proposal will be to examine the clinical performance of both physicians in training as well as experienced faculty in pre and post call situations. Groups will be matched for gender, age, experience and employment duration during regular hours versus immediate post call hour.
Detailed description
This is a prospective study evaluating the reaction time among attending anesthesiologists, and anesthesiology residents who take night shift call and are suffering from sleep deprivation. Investigators plan to examine clinical performance by measuring reaction times using a 10 minute psychomotor vigilance test device on physicians in training as well as experienced physicians in pre and post call situations.
All subjects will be informed of the scope and purpose of the study.
- Attending Anesthesiologists: Gender, age, years of experience, years of employment at the institution, hours of sleep and circadian rhythm will be taken into effect.
- Residents/Fellows: Gender, age, years of experience, years of employment at the institution and circadian rhythm will be taken into effect.
All study subjects will be asked to fill a questionnaire regarding demographic data, coping strategy Index.
- Baseline instruments; including demographics, and coping strategy indicator (CSI), will be administrated.
- Reaction time, mood and simple cognitive test will be measured at approximately 7 am of a regular day, (when the subject is not on call).
- Reaction time, mood and simple cognitive test will be measured at approximately 7 am of after a call night.
This proposal attempts to examine the impact of night shift on mood, cognitive and motor task performance in physicians as compared to regular hours.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Post-call anesthesiologists | – | Other: No interventionAttending anesthesiologists, and Anesthesiology residents |
| Regular-shift anesthesiologists | – | Other: No interventionAttending anesthesiologists, and Anesthesiology residents |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Twenty-four attending anesthesiologists and anesthesiology residents
Key inclusion criteria (2 listed)
- Staff Attending Anesthesiologist who takes night shift call
- Anesthesiology residents who take night shift call
Key exclusion criteria (1 listed)
- Staff unwilling to participate
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 |
|---|---|---|
| No interventionThis is an observational study. | Other | Post-call anesthesiologists, Regular-shift anesthesiologists |
Primary outcome
Reaction time
Time frame: Regular Day and Post-call shifts - Through study completion, an average of one year.
We plan to measure reaction times via a 10-minute psychomotor vigilance test (PVT, Ambulatory Monitoring Inc., NY) device. The PVT-192 Psychomotor Vigilance Task Monitor is a hand-held, self-contained system used for repetitive reaction time measurements.
Visual Analog Scale
Time frame: Regular Day and Post-call shifts - Through study completion, an average of one year.
Subjective sleepiness and alertness (and other parameters) will be measured via the Visual Analog Scale (VAS). This Questionnaire consists of several 100 millimeter lines, each of which is labeled at one end with the words "not at all" and the other end with the word "extremely". Centered under each line are the test adjectives which are as follows: "alert, able to concentrate, " anxious", "energetic", "feel confident", "irritable", "Jittery/nervous", "sleepy", and "talkative". The participants indicate the point on the line, which corresponded to the way they feel along the continuum at the time the test is taken. The score for each item consists of a number of millimeters from the left side of the line to the location at which the participants placed their mark.
Profile of mood states
Time frame: Regular Day and Post-call shifts - Through study completion, an average of one year.
Subjective evaluations of mood will be made with the Profile of Mood States (POMS). The POMS is a 65-Item questionnaire which, when scored according to the specific templates, measures affect or mood on scales: 1) Tension-Anxiety, 2) Depression-dejection, 3) anger-hostility, 4) vigor-activity, 5) fatigue-inertia, and 6) confusion-bewilderment. Factor scores on each scale will be analyzed.
1 secondary outcome
Coping Strategy Indicator (CSI):
Time frame: Regular-shift - Through study completion, an average of one year.
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 9 Sep 2016.
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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.
Haleh Saadat, MD principal investigator
Nationwide Children's Hospital
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 Sleep Deprivation, run by Haleh Saadat at 1 site in United States.
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 2 inclusion and 1 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 9 Sep 2016. 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 United States. 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?
Reaction time (time frame: Regular Day and Post-call shifts - Through study completion, an average of one year.). The study lists 3 primary outcomes in all. 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 9 Sep 2016.