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 range18 Years – 65 Years

SexALL

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.

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.

Participant's awareness of their fatigue level using a composite of survey data taken by each participant.

Timeframe: Surveys are taken by the participant every 15 minutes during regular stops during each session.

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 range18 Years – 65 Years

SexALL

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.

Participant's awareness of their fatigue level using a composite of survey data taken by each participant.

Timeframe: Surveys are taken by the participant every 15 minutes during regular stops during each session.