Clinical trial NCT01672489: Objective Assessment of the Effects of Shift Work on Drowsiness and Driving Impairment in Hospital Staff
Official title: Objective Assessment of the Effects of Shift Work on Drowsiness and Driving Impairment in Hospital Staff
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
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
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
Collaborators: name: Institute for Breathing and Sleep, Australia
name: Liberty Mutual
First posted: 2012-08-27
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
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.).

Brief 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Brain activity including "microsleeps" using electroencephalography (EEG).
timeFrame: Up to 3 hours per session for each participant.
measure: Participants' fatigue and drowsiness level while driving using Optalert.
timeFrame: Up to 3 hours per session for each participant.
measure: Driving performance measured by an instrumented vehicle.
timeFrame: Up to 3 hours per session for each participant.
measure: Alertness level and level of fatigue measured by a composite of variables from a Zephyr Bioharness device worn by each participant.
timeFrame: Up to 3 hours per session for each participant.
measure: Alertness level and level of fatigue from a composite of variables measured by an Affectiva Q-Sensor worn by each participant.
timeFrame: Up to 3 hours per session for each participant.
measure: Participants' fatigue and drowsiness level measured by an eye tracker device.
timeFrame: Up to 3 hours per session for each participant.
measure: Participant's awareness of their fatigue level using a composite of survey data taken by each participant.
timeFrame: Surveys are taken by the participant every 15 minutes during regular stops during each session.
Secondary outcomes:
measure: Sleep and wake times using an Actiwatch device.
timeFrame: Up to 7 weeks per subject worn continuously during enrollment in the study.
measure: Sleep and wake times using a 'sleep and work' diary completed by each subject.
timeFrame: Up to 7 weeks per participant completed daily.
measure: Participants' view of their health and well-being using a composite of surveys administered during subject enrollment.
timeFrame: Up to 2 hours per subject during the start of their participation in the study.
Other outcomes:
Locations:
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
Study officials:
affiliation: Brigham and Women's Hospital
name: Charles Czeisler, PH.D., M.D.
role: PRINCIPAL_INVESTIGATOR
References: