Trials / Active Not Recruiting
Active Not RecruitingNCT01672489
Objective Assessment of the Effects of Shift Work on Drowsiness and Driving Impairment in Hospital Staff
- Status
- Active Not Recruiting
- Phase
- —
- Study type
- Observational
- Enrollment
- 19 (actual)
- Sponsor
- Brigham and Women's Hospital · Academic / Other
- Sex
- All
- Age
- 18 Years – 65 Years
- Healthy volunteers
- Accepted
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
Timeline
- Start date
- 2011-07-01
- Primary completion
- 2026-12-01
- Completion
- 2026-12-01
- First posted
- 2012-08-27
- Last updated
- 2024-08-14
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT01672489. Inclusion in this directory is not an endorsement.