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

NCT01672489 | Active Not Recruiting

• 1 other identifier: 2011P000370
• Study Type: observational
• Target: 19
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (7)

• Brain activity including "microsleeps" using electroencephalography (EEG).

  Continuous EEG recordings are made during each track driving session using a portable Vitaport 4 system (Temec ®).

  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.

  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.

  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).

  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).

  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.

  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.

  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.

  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.

  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.

  Up to 2 hours per subject during the start of their participation in the study.

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.).

You may qualify if:

• 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.

Sponsors & Collaborators

• Brigham and Women's Hospital: lead
• Institute for Breathing and Sleep, Australia: collaborator
• Liberty Mutual: collaborator

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02215, United States

Location

MeSH Terms

Conditions

Sleepiness

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Charles Czeisler, PH.D., M.D.

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Charles A. Czeisler PH.D., M.D.

Study Record Dates

• First Submitted: August 16, 2012
• First Posted: August 27, 2012
• Study Start: July 1, 2011
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: August 14, 2024

Record last verified: 2024-08

Locations

US (1)