Objective Assessment of the Effects of Shift Work on Drowsiness and Driving Impairment in Hospital Staff

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Institute for Breathing and Sleep, Australia
Liberty Mutual
Information provided by (Responsible Party):
Charles Andrew Czeisler, MD, PhD, Brigham and Women's Hospital
ClinicalTrials.gov Identifier:
NCT01672489
First received: August 16, 2012
Last updated: August 6, 2013
Last verified: August 2013
  Purpose

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.


Condition
Impaired Driving
Sleep Driving

Study Type: Observational
Study Design: Observational Model: Cohort
Official Title: Objective Assessment of the Effects of Shift Work on Drowsiness and Driving Impairment in Hospital Staff

Resource links provided by NLM:


Further study details as provided by Brigham and Women's Hospital:

Primary Outcome Measures:
  • Brain activity including "microsleeps" using electroencephalography (EEG). [ Time Frame: Up to 3 hours per session for each participant. ] [ Designated as safety issue: No ]
    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. ] [ Designated as safety issue: No ]
    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. ] [ Designated as safety issue: No ]
    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. ] [ Designated as safety issue: No ]
    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. ] [ Designated as safety issue: No ]
    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. ] [ Designated as safety issue: No ]
    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. ] [ Designated as safety issue: No ]
    Questionnaires include: Karolinska Sleepiness Scale, Likelihood of Falling Asleep Questionnaire, and the Sleepiness Symptoms Questionnaire.


Secondary Outcome Measures:
  • Sleep and wake times using an Actiwatch device. [ Time Frame: Up to 7 weeks per subject worn continuously during enrollment in the study. ] [ Designated as safety issue: No ]
    The Actiwatch-L recorder is a small wrist worn device (17 grams) that measures activity and ambient light exposure.

  • Sleep and wake times using a 'sleep and work' diary completed by each subject. [ Time Frame: Up to 7 weeks per participant completed daily. ] [ Designated as safety issue: No ]
    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.

  • 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. ] [ Designated as safety issue: No ]
    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.


Enrollment: 19
Study Start Date: July 2011
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
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

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.).

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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01672489

Locations
United States, Massachusetts
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02215
Sponsors and Collaborators
Brigham and Women's Hospital
Institute for Breathing and Sleep, Australia
Liberty Mutual
Investigators
Principal Investigator: Charles Czeisler, PH.D., M.D. Brigham and Women's Hospital
  More Information

No publications provided

Responsible Party: Charles Andrew Czeisler, MD, PhD, Charles A. Czeisler PH.D., M.D., Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT01672489     History of Changes
Other Study ID Numbers: 2011P000370
Study First Received: August 16, 2012
Last Updated: August 6, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Brigham and Women's Hospital:
Driving
Drowsy
Drive
Shift Work Disorder
SWD
EEG
ECG
Actiwatch
Diary
Bioharness
Q-Sensor
Q Sensor
Liberty Mutual
sleep
impaired
Optalert
tracker
vehicle
questionnaire
survey

ClinicalTrials.gov processed this record on October 19, 2014