Overview

This trial is active, not recruiting.

Conditions impaired driving, sleep driving
Sponsor Brigham and Women's Hospital
Collaborator Institute for Breathing and Sleep, Australia
Start date July 2011
End date December 2016
Trial size 19 participants
Trial identifier NCT01672489, 2011P000370

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort

Primary Outcomes

Measure
Brain activity including "microsleeps" using electroencephalography (EEG).
time frame: Up to 3 hours per session for each participant.
Participants' fatigue and drowsiness level while driving using Optalert.
time frame: Up to 3 hours per session for each participant.
Driving performance measured by an instrumented vehicle.
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.
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.
time frame: Up to 3 hours per session for each participant.
Participants' fatigue and drowsiness level measured by an eye tracker device.
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.
time frame: 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.
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.
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.
time frame: Up to 2 hours per subject during the start of their participation in the study.

Eligibility Criteria

Male or female participants from 18 years up to 65 years old.

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.

Additional Information

Official title Objective Assessment of the Effects of Shift Work on Drowsiness and Driving Impairment in Hospital Staff
Principal investigator Charles Czeisler, PH.D., M.D.
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.
Trial information was received from ClinicalTrials.gov and was last updated in August 2015.
Information provided to ClinicalTrials.gov by Brigham and Women's Hospital.