Recovery Napping Protocol for Anesthesiologist Performance (R-NAP)

November 14, 2025 updated by: Lilot Marc, Claude Bernard University
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)

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Residents in anesthesiology will be recruited on voluntary basis. They will pass the high fidelity simulation twice, once as a baseline measure under normal conditions after a typical night at home and once sleep deprived after a night shift.

BASELINE Participants will wear actigraphy bracelets to define their sleep pattern for 2 weeks, Then they will spent a normal night at home before coming to the performance center in the afternoon (13h to18h). There they will respond to questions about stress and sleep, will be equipped with smart shirts (HEXOSKIN) to measure their level of stress during the performance, and then undertake a crisis simulation. Afterwards they pass some standardized cognitive tests.

TRAINING The whole year group of residents will be trained to understand sleep management and learn power napping. After the workshop they will individually be trained during 2 weeks including some follow up calls.

INTERVENTION The participants carry again actigraphy bracelets. Then they work a night shift in their service where they usually sleep less than four hours. The morning after the shift participants are free to spend how the like while sleep is being controlled with actigraphy bracelets. In the afternoon (13 to 18h) they return for the second time to the performance center. They are randomly assigned to a napping or non napping group and equipped with ambulatory ECG (Hexoskin) as well es ambulatory EEG (Somfit). After the intervention period (nap or leisure time) they proceed with the same performance measures as at baseline including a simulation crisis and computerized cognitive tests.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
44

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • France
      • Lyon, France
        • Claude Bernard University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • No Consent

Study Plan

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

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: NAP GROUP
30min of Powernap before second performance measure
Behavioral: POWERNAP
POWERNAP of max 30min while participants ly down comfortably
No Intervention: NO NAP GROUP
30min of free quiet occupation before second performance measure

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Score of technical clinical performance via rating grids
Time Frame: 2 days
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
Time Frame: 2 days
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Heart Rate as physiological stress measure
Time Frame: 2 days
Objective stress level during performance measured by duration of heart rate tachycardia (> 100 bpm) measured with ambulatory ECG (Hexoskin)
2 days
Visual analogue scale for the evaluation of psychological stress
Time Frame: 2 days
Subjective stress level during performance measured with visual analogue scales (VAS) on 100mm from zero intensity to maximal intensity. High stress levels are worse.
2 days
Reaction time in Alertness task
Time Frame: 2 days
Computerized alertness test named SART (Sustained Attention to Response Task) programmed based on psytoolkit, 150 trials in test phase. Faster speed (low RT) for correct responses indicates a better performance.
2 days
Sleepiness Score
Time Frame: 2 days
Karolinska Sleepiness Scale, Score between 1(extremely alert) to 9 (very sleepy, great effort to keep awake, fighting sleep)
2 days
Pain Empathy Accuracy
Time Frame: 2 days

Capacity to distinguish painful and non painful faces according to a computerized pre-validated pain empathy test.

Accuracy rates for hits and false alarms will be computed in percent: ((hits + correct rejections) / total responses). HIgher percentages indicate better performance.
2 days
Pain Empathy D prime
Time Frame: 2 days
Capacity to distinguish painful and non painful faces according to a computerized pre-validated pain empathy test. Also d prime as sensitivity score will provide a score on how well participants were able to distinguish the presence of the signal (pain) from the absence (non pain). The higher d prime the better (d' = z(H) - z(F))
2 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Claude Bernard University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Jean-Jacques Lehot, PhD, jean-jacques.lehot2@univ-lyon1.fr

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 8, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 30, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 30, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 30, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 11, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 16, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 17, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 14, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • R-NAP

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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