Suspended

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

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What is being collected

Data Collection

Who is being recruted

Signs and Symptoms

+ Pathological Conditions, Signs and Symptoms

+ Sleepiness

From 18 to 65 Years
+5 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Cohort

Tracking disease incidence in order to identify risk factors and understand disease progression over time.
Observational
Study Start: July 2011
See protocol details

Summary

Principal SponsorBrigham and Women's Hospital
Last updated: August 14, 2024
Sourced from a government-validated database.Claim as a partner

Study start date: July 1, 2011

Actual date on which the first participant was enrolled.

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.

Principal SponsorBrigham and Women's Hospital
Last updated: August 14, 2024
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

19 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Cohort

These studies follow a group of individuals with common characteristics (such as a condition or birth year) over a specific period to study health outcomes or exposures.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 65 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Signs and SymptomsPathological Conditions, Signs and SymptomsSleepiness

Criteria

5 inclusion criteria required to participate
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

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Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Study Objectives

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Brigham and Women's Hospital

Boston, United StatesOpen Brigham and Women's Hospital in Google Maps
SuspendedOne Study Center
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