Impaired DrivingNCT01672489
Objective Assessment of the Effects of Shift Work on Drowsiness and Driving Impairment in Hospital Staff
An observational study of Impaired Driving and Sleep Driving, run by Brigham and Women's Hospital at 1 site in United States.
Trial summary
The purpose of this protocol is to assess the risk of drowsy driving amongst shift workers using objective measures of drowsiness and driving performance in an instrumented research vehicle. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Impaired Driving, Sleep Driving
- How many people
- 19 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2011to Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Participants in this study include shift workers who undertake extended duration shifts (16 hours or longer) or night shifts (e.g. resident physicians, nursing staff and allied health staff, police, firefighters, etc.).
Who may be able to join
- 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.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Brigham and Women's Hospital
Boston, Massachusetts, 02215
About this study
The purpose of this protocol is to assess the risk of drowsy driving amongst shift workers using objective measures of drowsiness and driving performance in an instrumented research vehicle.
Read the 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.
- Conditions
- Impaired Driving, Sleep Driving
- Keywords
- Drowsy, Drive, Driving, Shift Work Disorder, SWD, EEG, ECG, Actiwatch, Diary, Bioharness, Q-Sensor, Q Sensor, Liberty Mutual, sleep, impaired, Optalert, tracker, vehicle, questionnaire, survey
- Medical subject headings
- Sleepiness
What is being measured
The primary outcome is the main question the study is designed to answer.
Brain activity including "microsleeps" using electroencephalography (EEG).
Continuous EEG recordings are made during each track driving session using a portable Vitaport 4 system (Temec ®).
Measured: Up to 3 hours per session for each participant.
Participants' fatigue and drowsiness level while driving using Optalert.
Optalert is a portable device, worn like sunglasses, designed to detect drowsiness, particularly when driving.
Measured: Up to 3 hours per session for each participant.
Driving performance measured by an instrumented vehicle.
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.
Measured: Up to 3 hours per session for each participant.
Alertness level and level of fatigue measured by a composite of variables from a Zephyr Bioharness device worn by each participant.
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).
Measured: Up to 3 hours per session for each participant.
Alertness level and level of fatigue from a composite of variables measured by an Affectiva Q-Sensor worn by each participant.
Additional autonomic nervous systems measures are obtained from a wrist-worn sensor (Affectiva Q-Sensor).
Measured: Up to 3 hours per session for each participant.
Participants' fatigue and drowsiness level measured by an eye tracker device.
An eye tracking device, owned by Liberty Mutual, is used to measure eye activity.
Measured: Up to 3 hours per session for each participant.
Participant's awareness of their fatigue level using a composite of survey data taken by each participant.
Questionnaires include: Karolinska Sleepiness Scale, Likelihood of Falling Asleep Questionnaire, and the Sleepiness Symptoms Questionnaire.
Measured: Surveys are taken by the participant every 15 minutes during regular stops during each session.
Secondary outcomes (3)
Sleep and wake times using an Actiwatch device.
The Actiwatch-L recorder is a small wrist worn device (17 grams) that measures activity and ambient light exposure.
Measured: Up to 7 weeks per subject worn continuously during enrollment in the study.
Sleep and wake times using a 'sleep and work' diary completed by each subject.
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.
Measured: Up to 7 weeks per participant completed daily.
Participants' view of their health and well-being using a composite of surveys administered during subject enrollment.
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.
Measured: Up to 2 hours per subject during the start of their participation in the study.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2012 (estimated)
- Study startJul 2011
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Impaired DrivingStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe 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
- Other
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Institute for Breathing and Sleep, Australia, Liberty Mutual
- Responsible party
- Principal investigator, Charles A. Czeisler, PhD, MD, Brigham and Women's Hospital
- Investigators
- Charles Czeisler, PH.D., M.D., Principal investigator, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01672489
- Sponsor's protocol ID
- 2011P000370
- Status last verified
- Aug 2024
- First submitted
- 16 Aug 2012
- Last updated
- 14 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Objective Assessment of the Effects of Shift Work on Drowsiness and Driving Impairment in Hospital Staff
- ClinicalTrials.gov ID
- NCT01672489
- Acronym / sponsor ID
- 2011P000370
- Conditions
- Impaired Driving, Sleep Driving
- Keywords
- Drowsy, Drive, Driving, Shift Work Disorder, SWD, EEG, ECG, Actiwatch
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Collaborators
- Institute for Breathing and Sleep, Australia, Liberty Mutual
- Study start
- Jul 2011
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 27 Aug 2012 (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 this protocol is to assess the risk of drowsy driving amongst shift workers using objective measures of drowsiness and driving performance in an instrumented research vehicle.
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 design
- Observational model
- Cohort
- Time perspective
- Other
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Participants in this study include shift workers who undertake extended duration shifts (16 hours or longer) or night shifts (e.g. resident physicians, nursing staff and allied health staff, police, firefighters, etc.).
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Brain activity including "microsleeps" using electroencephalography (EEG).
Time frame: Up to 3 hours per session for each participant.
Continuous EEG recordings are made during each track driving session using a portable Vitaport 4 system (Temec ®).
Participants' fatigue and drowsiness level while driving using Optalert.
Time frame: Up to 3 hours per session for each participant.
Optalert is a portable device, worn like sunglasses, designed to detect drowsiness, particularly when driving.
Driving performance measured by an instrumented vehicle.
Time frame: Up to 3 hours per session for each participant.
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.
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.
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).
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.
Additional autonomic nervous systems measures are obtained from a wrist-worn sensor (Affectiva Q-Sensor).
Participants' fatigue and drowsiness level measured by an eye tracker device.
Time frame: Up to 3 hours per session for each participant.
An eye tracking device, owned by Liberty Mutual, is used to measure eye activity.
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.
Questionnaires include: Karolinska Sleepiness Scale, Likelihood of Falling Asleep Questionnaire, and the Sleepiness Symptoms Questionnaire.
3 secondary outcomes
Sleep and wake times using an Actiwatch device.
Time frame: Up to 7 weeks per subject worn continuously during enrollment in the study.
Sleep and wake times using a 'sleep and work' diary completed by each subject.
Time frame: Up to 7 weeks per participant completed daily.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2024.
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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.
Charles Czeisler, PH.D., M.D. principal investigator
Brigham and Women'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 Impaired Driving and Sleep Driving, run by Brigham and Women's Hospital 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 6 inclusion and 0 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: under way, not looking for participants, as of the sponsor's last update on 14 Aug 2024. 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?
This study is still under way. Results are not available in the source record yet.
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?
Brain activity including "microsleeps" using electroencephalography (EEG). (time frame: Up to 3 hours per session for each participant.). The study lists 7 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 14 Aug 2024.