NCT05619081

Brief Summary

Sleep deprivation impacts performance of shift workers in health care. Anesthesiologists are a population at risk that endures stressful situations and changing working hours. The decreased performance could be the cause for undesirable events. Power-napping is known to be an efficient technique to mitigate the detrimental effects of sleep deprivation and is a feasible measure to implement in critical care units. Still there are few insights that measure the clinical relevance in the field. With the high-fidelity simulations this study is able to measure clinical performance and test for those effects. Therefore we propose a prospective, monocentric study to evaluate a power-napping protocol (less than 30min)

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
44

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 30, 2022

Completed
1 month until next milestone

Study Start

First participant enrolled

November 8, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

November 16, 2022

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2023

Completed
Last Updated

November 17, 2025

Status Verified

November 1, 2025

Enrollment Period

8 months

First QC Date

September 30, 2022

Last Update Submit

November 14, 2025

Conditions

Keywords

Power-nappingHigh Fidelity SimulationNight ShiftClinical Performance

Outcome Measures

Primary Outcomes (2)

  • Score of technical clinical performance via rating grids

    Technical clinical performance according to a standardizes grid (Score from 0 to 100) for each critical care scenario evaluated by experts based on the video. Higher scores indicate better performance

    2 days

  • Score of Non-Technical clinical performance via Ottawa Crisis Resource Management Scale

    Non-technical clinical performance rated by experts based on the video from 6 to 42 of the Ottawa Crisis Resource Management Scale. Higher scores indicate better performance

    2 days

Secondary Outcomes (6)

  • Heart Rate as physiological stress measure

    2 days

  • Visual analogue scale for the evaluation of psychological stress

    2 days

  • Reaction time in Alertness task

    2 days

  • Sleepiness Score

    2 days

  • Pain Empathy Accuracy

    2 days

  • +1 more secondary outcomes

Study Arms (2)

NAP GROUP

EXPERIMENTAL

30min of Powernap before second performance measure

Behavioral: POWERNAP

NO NAP GROUP

NO INTERVENTION

30min of free quiet occupation before second performance measure

Interventions

POWERNAPBEHAVIORAL

POWERNAP of max 30min while participants ly down comfortably

NAP GROUP

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Second to Fifth year of residency
  • Completing night shifts at anesthesia/reanimation unit

You may not qualify if:

  • No Consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Claude Bernard University

Lyon, France

Location

Related Publications (9)

  • Rosekind MR, Gander PH, Gregory KB, Smith RM, Miller DL, Oyung R, Webbon LL, Johnson JM. Managing fatigue in operational settings 2: An integrated approach. Behav Med. 1996 Winter;21(4):166-70. doi: 10.1080/08964289.1996.9933754.

    PMID: 8731493BACKGROUND
  • Nollet M, Wisden W, Franks NP. Sleep deprivation and stress: a reciprocal relationship. Interface Focus. 2020 Jun 6;10(3):20190092. doi: 10.1098/rsfs.2019.0092. Epub 2020 Apr 17.

    PMID: 32382403BACKGROUND
  • Ehooman F, Wildenberg L, Manquat E, Makoudi S, Demiri S, Carbonne H, Bardon J. Connected devices to evaluate sleep, physical activity and stress pattern of anaesthesiology and intensive care residents. Eur J Anaesthesiol. 2020 Jul;37(7):616-618. doi: 10.1097/EJA.0000000000001207. No abstract available.

    PMID: 32516181BACKGROUND
  • Stewart NH, Arora VM. The Impact of Sleep and Circadian Disorders on Physician Burnout. Chest. 2019 Nov;156(5):1022-1030. doi: 10.1016/j.chest.2019.07.008. Epub 2019 Jul 25.

    PMID: 31352036BACKGROUND
  • Landrigan CP, Rothschild JM, Cronin JW, Kaushal R, Burdick E, Katz JT, Lilly CM, Stone PH, Lockley SW, Bates DW, Czeisler CA. Effect of reducing interns' work hours on serious medical errors in intensive care units. N Engl J Med. 2004 Oct 28;351(18):1838-48. doi: 10.1056/NEJMoa041406.

    PMID: 15509817BACKGROUND
  • Howard SK, Gaba DM, Smith BE, Weinger MB, Herndon C, Keshavacharya S, Rosekind MR. Simulation study of rested versus sleep-deprived anesthesiologists. Anesthesiology. 2003 Jun;98(6):1345-55; discussion 5A. doi: 10.1097/00000542-200306000-00008.

    PMID: 12766642BACKGROUND
  • Arzalier-Daret S, Buleon C, Bocca ML, Denise P, Gerard JL, Hanouz JL. Effect of sleep deprivation after a night shift duty on simulated crisis management by residents in anaesthesia. A randomised crossover study. Anaesth Crit Care Pain Med. 2018 Apr;37(2):161-166. doi: 10.1016/j.accpm.2017.05.010. Epub 2017 Sep 4.

    PMID: 28882740BACKGROUND
  • Dutheil F, Bessonnat B, Pereira B, Baker JS, Moustafa F, Fantini ML, Mermillod M, Navel V. Napping and cognitive performance during night shifts: a systematic review and meta-analysis. Sleep. 2020 Dec 14;43(12):zsaa109. doi: 10.1093/sleep/zsaa109.

    PMID: 32492169BACKGROUND
  • Dutheil F, Danini B, Bagheri R, Fantini ML, Pereira B, Moustafa F, Trousselard M, Navel V. Effects of a Short Daytime Nap on the Cognitive Performance: A Systematic Review and Meta-Analysis. Int J Environ Res Public Health. 2021 Sep 28;18(19):10212. doi: 10.3390/ijerph181910212.

    PMID: 34639511BACKGROUND

MeSH Terms

Conditions

Sleep Deprivation

Condition Hierarchy (Ancestors)

DyssomniasSleep Wake DisordersNervous System DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsMental Disorders

Study Officials

  • Jean-Jacques Lehot, PhD

    jean-jacques.lehot2@univ-lyon1.fr

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: Randomised Control Trial (RCT)
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.D PhD, Principal Investigator

Study Record Dates

First Submitted

September 30, 2022

First Posted

November 16, 2022

Study Start

November 8, 2022

Primary Completion

June 30, 2023

Study Completion

June 30, 2023

Last Updated

November 17, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will not share

Locations