- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01672489
Objective Assessment of the Effects of Shift Work on Drowsiness and Driving Impairment in Hospital Staff
Study Overview
Status
Conditions
Detailed Description
Specific Aim 1. To test the hypothesis that on road (track) driving performance will deteriorate (variation in lateral lane position and the rate of out of lane driving events) and the frequency of episodes of severe sleepiness will increase ("microsleeps" on EEG and Johns' Drowsiness Score >4) in shift workers following an extended work shift or night shift compared to a rested state, following day shifts.
Specific Aim 2. To test the hypothesis that ocular measures of alertness (percent of time with eyes closed, eye tracking and Johns' Drowsiness Score) are related to abnormal driving performance (driving out of the lane) and "microsleeps" during on road (track) driving.
Specific Aim 2a. To test the hypothesis that autonomic measures, ECG, respiration (measured with the Bioharness), skin conductance level and peripheral blood flow (measured with the Q sensor), are related to abnormal driving performance (driving out of the lane) and "microsleeps" during on road (track) driving
Specific Aim 3. To test the hypothesis that self-reported sleepiness is related to on road (track) driving performance and episodes of severe sleepiness following extended working shifts or night shifts.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Massachusetts
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Boston, Massachusetts, United States, 02215
- Brigham and Women's Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Participant must be a shift worker who undertakes extended duration shifts (16 hours or longer) or overnight shifts
- Participant must be between the ages of 18-65y
- Participant needs to have held a US driving license for two years previously or an International Driving license for two years with 6-months regular (>2/week) US driving experience
- Participants who wear corrective eye wear (i.e., glasses) are ONLY eligible to participate if they have a valid prescription so we can fit the Optalert glasses with their prescription lenses
- Resident physicians are only recruited if the combination of their time involvement in the study (i.e., any additional time beyond the time that it would ordinarily take them to commute home from work), together with their scheduled work hours, would fall within ACGME standards for duty hours for resident physicians.
Exclusion Criteria: Exclusion criteria includes all parameters outside the inclusion criteria above.
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Brain activity including "microsleeps" using electroencephalography (EEG).
Time Frame: Up to 3 hours per session for each participant.
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Continuous EEG recordings are made during each track driving session using a portable Vitaport 4 system (Temec ®).
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Up to 3 hours per session for each participant.
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Participants' fatigue and drowsiness level while driving using Optalert.
Time Frame: Up to 3 hours per session for each participant.
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Optalert is a portable device, worn like sunglasses, designed to detect drowsiness, particularly when driving.
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Up to 3 hours per session for each participant.
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Driving performance measured by an instrumented vehicle.
Time Frame: Up to 3 hours per session for each participant.
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A dual control instrumented vehicle, owned by Liberty Mutual, has been used for each driving session with each subject.
This vehicle is fitted with a lane tracking system, as well as the capability to instruct and record responses from the driver.
Lane position is monitored and recorded continuously with lateral and rear facing cameras.
Data is logged to on-board computers.
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Up to 3 hours per session for each participant.
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Alertness level and level of fatigue measured by a composite of variables from a Zephyr Bioharness device worn by each participant.
Time Frame: Up to 3 hours per session for each participant.
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The Zephyr Bioharness uses smart fabric sensors (non-adhesive) to measure electrocardiography (ecg), respiratory wave form, chest skin temperature, posture and activity (3-axis accelerometer).
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Up to 3 hours per session for each participant.
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Alertness level and level of fatigue from a composite of variables measured by an Affectiva Q-Sensor worn by each participant.
Time Frame: Up to 3 hours per session for each participant.
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Additional autonomic nervous systems measures are obtained from a wrist-worn sensor (Affectiva Q-Sensor).
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Up to 3 hours per session for each participant.
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Participants' fatigue and drowsiness level measured by an eye tracker device.
Time Frame: Up to 3 hours per session for each participant.
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An eye tracking device, owned by Liberty Mutual, is used to measure eye activity.
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Up to 3 hours per session for each participant.
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Participant's awareness of their fatigue level using a composite of survey data taken by each participant.
Time Frame: Surveys are taken by the participant every 15 minutes during regular stops during each session.
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Questionnaires include: Karolinska Sleepiness Scale, Likelihood of Falling Asleep Questionnaire, and the Sleepiness Symptoms Questionnaire.
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Surveys are taken by the participant every 15 minutes during regular stops during each session.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Sleep and wake times using an Actiwatch device.
Time Frame: Up to 7 weeks per subject worn continuously during enrollment in the study.
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The Actiwatch-L recorder is a small wrist worn device (17 grams) that measures activity and ambient light exposure.
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Up to 7 weeks per subject worn continuously during enrollment in the study.
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Sleep and wake times using a 'sleep and work' diary completed by each subject.
Time Frame: Up to 7 weeks per participant completed daily.
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Subjects maintain a sleep/work diary to provide a self-assessment of their sleep quantity and quality, work periods, as well as caffeine, medication, and alcohol intake.
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Up to 7 weeks per participant completed daily.
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Participants' view of their health and well-being using a composite of surveys administered during subject enrollment.
Time Frame: Up to 2 hours per subject during the start of their participation in the study.
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Participants are given the Berlin Apnea questionnaire, the MASLACH burnout inventory, and the Owl and Lark Questionnaire during enrollment.
The data from these questionnaires will be used for analysis purposes.
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Up to 2 hours per subject during the start of their participation in the study.
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Charles Czeisler, PH.D., M.D., Brigham and Women's Hospital
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2011P000370
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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