Shift Hours' Impact on Fatigue and Tracking of Eye Dynamics

NCT07192380 | Not Yet Recruiting DMC

• 2 other identifiers: PSI-24-05ID-RCB
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to learn how night shift-induced sleep debt affects oculomotor patterns, attentional state, and diagnostic performance in emergency radiologists. The main questions it aims to answer are:

• Does sleep debt from a night shift alter oculomotor parameters, as eyes movements (speed and amplitude), fixation duration, pupil size?
• Does a night shift impact radiologists' diagnostic accuracy, attentional state, and perceived fatigue? Researchers will compare radiologists after a night shift (sleep-deprived) with the same radiologists after a night of rest (control) to see if fatigue-related changes affect both visual exploration strategies and diagnostic performance. Participants will:
• Perform a guided saccade task assessed by eye tracking (primary endpoint),
• Read thoracic CT scans (with and without pulmonary embolism cases) to assess diagnostic performance and visual exploration patterns,
• Undergo EEG recording to measure attentional state,
• Complete self-report questionnaires on sleepiness and fatigue.

Conditions

Sleep Deprivation; Sleepiness; Eye-Tracking Technology; Radiologists; Tomography; Electroencephalography

Keywords

Night-Shift; Radiology; performance; Eye-tracking; Fatigue; Eye strain

Outcome Measures

Primary Outcomes (1)

• Comparison of slope of the relationship between maximum speed and saccade magnitude

  Slope of the relationship between maximum saccadic speed and saccade magnitude This parameter reflects the dynamics of saccadic eye movements. It is derived from the main sequence, which describes the linear relationship between the amplitude of a saccade (in degrees of visual angle) and its maximum velocity (in degrees per second). The slope quantifies how rapidly maximum saccadic speed increases with increasing saccade magnitude. A steeper slope indicates faster oculomotor responses for larger saccades, whereas a reduced slope may reflect fatigue, reduced alertness, or impaired oculomotor function.

  Comparison of measurement obtained during an 8-minute guided saccade task during the two measurement phases : after a night call and after a night's rest

Secondary Outcomes (9)

• Comparison of duration of fixations on areas of interest, in milliseconds

  Comparison of measurements taken on the morning after a night shift and on the morning after a night of rest

• Comparison of percent of embolisms detected

  Comparison of measurements taken on the morning after a night shift and on the morning after a night of rest

• Comparison of pupil diameter

  Comparison of measurements taken on the morning after a night shift and on the morning after a night of rest

• Comparison of attentional systems

  Comparison of measurement taken on the morning after a night shift and on the morning after a night of rest

• Assessment of self reported momentary sleepiness

  Questionnaire is completed before each measurement phase (after a night on call or after a night of rest)

Other Outcomes (1)

• Sleep-wake cycle over the last 24 hours

  Measurements taken 24 hours before each measurement phase (night shift and a night of rest)

Study Arms (1)

Study cohort

EXPERIMENTAL

Radiologists taking measurements after a night shift and after a night's rest

Device: Electroencephalogram; Device: Actigraphy; Device: Eye Tracking; Other: Questionnaires

Interventions

Electroencephalogram DEVICE

EEG measurement to assess attentional state

Also known as: EEG

Study cohort

Actigraphy DEVICE

Evaluation of sleep-wake phases 24 hours prior to eye tracking measurement

Also known as: Actimetry

Study cohort

Eye Tracking DEVICE

Assessment of ocular parameters during controlled eye tracking: guided saccade task followed by analysis of chest scans to detect pulmonary embolism. Measurement of ocular saccade parameters (distance, velocity), fixation time and pupil diameter. Measurements performed twice: after a night on call and after a night of rest.

Also known as: Oculometry

Study cohort

Questionnaires OTHER

Measurements of sleepiness (Karolinska Sleep Scale KSS, Epworth Sleep Scale ESS), mental fatigue (EVA Scale), insomnia (Insomnia Severity Index, ISI) and chronotype (Morningness Eveningness Questionnaire, MEQ) * Inclusion visit: MEQ * Before the first evaluation: ISI, KSS, ESS, EVA * Before the second evaluation: ISI, KSS, ESS, EVA

Study cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Associate radiologists at IMADIS Group
• In their current position for at least one year
• Working at one of the IMADIS Group on-call centers
• Performing night shifts during the study period
• Able to wear an actimeter watch during the study period (it may be removed during certain procedures, but must be put back on afterwards)
• Having given their free and informed consent to participate in the study
• Leave during the study period
• Pregnant women, women in labor, or breastfeeding women
• Subjects wearing glasses or contact lenses

You may not qualify if:

• \- Having slept more than 6 hours during the night shift

Sponsors & Collaborators

• IMADIS Technologies et Services: lead
• Lyon Neuroscience Research Center (CRNL): collaborator

Study Sites (1)

IMADIS Technologies et Services

Lyon, France, 69002, France

Location

Related Publications (13)

• Mallett S, Phillips P, Fanshawe TR, Helbren E, Boone D, Gale A, Taylor SA, Manning D, Altman DG, Halligan S. Tracking eye gaze during interpretation of endoluminal three-dimensional CT colonography: visual perception of experienced and inexperienced readers. Radiology. 2014 Dec;273(3):783-92. doi: 10.1148/radiol.14132896. Epub 2014 Jul 15.

  PMID: 25028782 BACKGROUND

• Diaz-Piedra C, Rieiro H, Suarez J, Rios-Tejada F, Catena A, Di Stasi LL. Fatigue in the military: towards a fatigue detection test based on the saccadic velocity. Physiol Meas. 2016 Sep;37(9):N62-75. doi: 10.1088/0967-3334/37/9/N62. Epub 2016 Aug 17.

  PMID: 27531394 BACKGROUND

• Di Stasi LL, McCamy MB, Macknik SL, Mankin JA, Hooft N, Catena A, Martinez-Conde S. Saccadic eye movement metrics reflect surgical residents' fatigue. Ann Surg. 2014 Apr;259(4):824-9. doi: 10.1097/SLA.0000000000000260.

  PMID: 24169184 BACKGROUND

• Gong H, Hsieh SS, Holmes DR 3rd, Cook DA, Inoue A, Bartlett DJ, Baffour F, Takahashi H, Leng S, Yu L, Fletcher JG, McCollough CH. Implementation and initial experience with an interactive eye-tracking system for measuring radiologists' visual search in diagnostic tasks using volumetric CT images. Proc SPIE Int Soc Opt Eng. 2022 Feb-Mar;12031:120310Q. doi: 10.1117/12.2611808. Epub 2022 Apr 4.

  PMID: 35721454 BACKGROUND

• De Gennaro L, Ferrara M, Urbani L, Bertini M. Oculomotor impairment after 1 night of total sleep deprivation: a dissociation between measures of speed and accuracy. Clin Neurophysiol. 2000 Oct;111(10):1771-8. doi: 10.1016/s1388-2457(00)00393-x.

  PMID: 11018491 BACKGROUND

• Ruutiainen AT, Durand DJ, Scanlon MH, Itri JN. Increased error rates in preliminary reports issued by radiology residents working more than 10 consecutive hours overnight. Acad Radiol. 2013 Mar;20(3):305-11. doi: 10.1016/j.acra.2012.09.028.

  PMID: 23452475 BACKGROUND

• Waite S, Kolla S, Jeudy J, Legasto A, Macknik SL, Martinez-Conde S, Krupinski EA, Reede DL. Tired in the Reading Room: The Influence of Fatigue in Radiology. J Am Coll Radiol. 2017 Feb;14(2):191-197. doi: 10.1016/j.jacr.2016.10.009. Epub 2016 Dec 9.

  PMID: 27956140 BACKGROUND

• Lee CS, Nagy PG, Weaver SJ, Newman-Toker DE. Cognitive and system factors contributing to diagnostic errors in radiology. AJR Am J Roentgenol. 2013 Sep;201(3):611-7. doi: 10.2214/AJR.12.10375.

  PMID: 23971454 BACKGROUND

• West CP, Tan AD, Habermann TM, Sloan JA, Shanafelt TD. Association of resident fatigue and distress with perceived medical errors. JAMA. 2009 Sep 23;302(12):1294-300. doi: 10.1001/jama.2009.1389.

  PMID: 19773564 BACKGROUND

• Rollinson DC, Rathlev NK, Moss M, Killiany R, Sassower KC, Auerbach S, Fish SS. The effects of consecutive night shifts on neuropsychological performance of interns in the emergency department: a pilot study. Ann Emerg Med. 2003 Mar;41(3):400-6. doi: 10.1067/mem.2003.77.

  PMID: 12605209 BACKGROUND

• Benitez-Provedo C, Talavera B, Garcia-Azorin D, Marcos-Dolado A. The cognitive impact of guard shifts in physicians: a before-after study. Neurol Sci. 2022 Mar;43(3):1701-1708. doi: 10.1007/s10072-021-05501-x. Epub 2021 Aug 18.

  PMID: 34409516 BACKGROUND

• Bruls RJM, Kwee RM. Workload for radiologists during on-call hours: dramatic increase in the past 15 years. Insights Imaging. 2020 Nov 23;11(1):121. doi: 10.1186/s13244-020-00925-z.

  PMID: 33226490 BACKGROUND

• Bundy JJ, Hage AN, Srinivasa RN, Gemmete JJ, Lee E, Gross JS, Healey TL, Solberg AO, Monroe EJ, Chick JFB. Burnout among Interventional Radiologists. J Vasc Interv Radiol. 2020 Apr;31(4):607-613.e1. doi: 10.1016/j.jvir.2019.06.002. Epub 2019 Jul 22.

  PMID: 31345730 BACKGROUND

MeSH Terms

Conditions

Sleep Deprivation; Sleepiness; Fatigue; Asthenopia

Interventions

Electroencephalography; Actigraphy; Eye-Tracking Technology; Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders; Eye Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Neurological; Diagnostic Techniques and Procedures; Diagnosis; Electrodiagnosis; Monitoring, Physiologic; Accelerometry; Investigative Techniques; Eye Movement Measurements; Diagnostic Techniques, Ophthalmological; Data Collection; Epidemiologic Methods; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Guillaume GORINCOUR, MD, PhD

  IMADIS Technologies et Services

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mylène SEUX, PhD

CONTACT

+33 6 63 37 60 44; m.seux@imadis-groupe.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 5, 2025
• First Posted: September 25, 2025
• Study Start: September 15, 2025
• Primary Completion (Estimated): May 15, 2026
• Study Completion (Estimated): May 15, 2026
• Last Updated: September 25, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Data will be available for 2 years after publication.
• Access Criteria: Request should be sent by email to the principal investigator, stating the objectives and purpose for using data. The request must come from a researcher working in the relevant field of research, and will be reviewed by the scientific committee. Principal investigator contact: g.gorincour@imadis-groupe.fr

Locations

FR (1)