Active — Not RecruitingNot Applicable

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

United States19 participantsStarted 2011-07

Plain-language 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.

Who can participate

Age range

18 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Timeframe: Up to 3 hours per session for each participant.

Participants' fatigue and drowsiness level while driving using Optalert.

Timeframe: Up to 3 hours per session for each participant.

Driving performance measured by an instrumented vehicle.

Timeframe: 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.

Timeframe: 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.

Timeframe: Up to 3 hours per session for each participant.

Participants' fatigue and drowsiness level measured by an eye tracker device.

Timeframe: Up to 3 hours per session for each participant.

Trial details

NCT IDNCT01672489

SponsorBrigham and Women's Hospital

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2026-12

View on ClinicalTrials.gov More Impaired Driving trials

Who can participate

Age range

18 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

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

Timeframe: Up to 3 hours per session for each participant.

Participants' fatigue and drowsiness level while driving using Optalert.

Timeframe: Up to 3 hours per session for each participant.

Driving performance measured by an instrumented vehicle.

Timeframe: 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.

Timeframe: 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.

Timeframe: Up to 3 hours per session for each participant.

Participants' fatigue and drowsiness level measured by an eye tracker device.

Timeframe: Up to 3 hours per session for each participant.