An observational study in Impaired Driving and Sleep Driving, sponsored by Brigham and Women's Hospital. Active, not recruiting at 1 site in United States. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-08-14.
Sponsored by Brigham and Women's Hospital · Observational
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.
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.
92 studies on the registry are indexed under Sleepiness; 20 are open to participants now.
This study's enrollment of 19 is below the median of 103 across 27 observational studies indexed under Sleepiness.
Browse Sleepiness studies →Brigham and Women's Hospital is the lead sponsor of 1,267 studies on the registry; 228 are open to participants now.
Of its 116 completed or terminated interventional studies of FDA-regulated products, 65 (56%) have results posted.
Counted across the registry records on this site, refreshed daily.
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.).
Inclusion Criteria:
Exclusion Criteria: Exclusion criteria includes all parameters outside the inclusion criteria above.
Brain activity including "microsleeps" using electroencephalography (EEG).
Continuous EEG recordings are made during each track driving session using a portable Vitaport 4 system (Temec ®).
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: Surveys are taken by the participant every 15 minutes during regular stops during each session.
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.
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.
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.
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.
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.
Time frame: Up to 2 hours per subject during the start of their participation in the study.
This study is active, not recruiting, as verified in Aug 2024. You cannot join it, but the record below documents what was studied.
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