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

NCT ID: NCT01672489

Last Updated: 2024-08-14

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 19 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2011-07-31
• Study Completion Date: 2026-12-31

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.

Conditions

Impaired Driving; Sleep Driving

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: OTHER

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Institute for Breathing and Sleep, Australia

OTHER

Sponsor Role: collaborator

Liberty Mutual

INDUSTRY

Sponsor Role: collaborator

Brigham and Women's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Charles A. Czeisler, PhD, MD

Charles A. Czeisler PH.D., M.D.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Charles Czeisler, PH.D., M.D.

Role: PRINCIPAL_INVESTIGATOR

Brigham and Women's Hospital

Locations

Brigham and Women's Hospital

Boston, Massachusetts, United States

Countries

United States

Other Identifiers

2011P000370

Identifier Type: -

Identifier Source: org_study_id