AzTrials
AzTrials

Sleep DeprivationR-NAPNCT05619081

Recovery Napping Protocol for Anesthesiologist Performance

A study testing POWERNAP in people with Sleep Deprivation and Critical Incident, run by Claude Bernard University at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Any ageHealthy volunteers can take part
Conditions the study is for
Sleep Deprivation, Critical Incident, Sleep
What is being tested?
POWERNAP
Could I receive a placebo?
No, everyone receives an active treatment
How many people
44 participants
Where
1 siteFrance
Study dates
8 Nov 2022to 30 Jun 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Who may be able to join

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

Who cannot join

  • No Consent

Trial locations and contacts

1 site in 1 country.

France1 site
  • Claude Bernard University

    Lyon

Other trials in France

About this study

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)

Read the 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.

Being tested
POWERNAP
Keywords
Power-napping, High Fidelity Simulation, Night Shift, Clinical Performance
Medical subject headings
Sleep Deprivation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • POWERNAPBehavioural

    POWERNAP of max 30min while participants ly down comfortably

Study groups in NCT05619081
Study groupRoleWhat they receive
NAP GROUPExperimental30min of Powernap before second performance measure
Receives: Behavioral: POWERNAP
NO NAP GROUPNo intervention30min of free quiet occupation before second performance measure

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: 2 days

  2. 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

    Measured: 2 days

Secondary outcomes (6)
  1. Heart Rate as physiological stress measure

    Objective stress level during performance measured by duration of heart rate tachycardia (> 100 bpm) measured with ambulatory ECG (Hexoskin)

    Measured: 2 days

  2. Visual analogue scale for the evaluation of psychological stress

    Subjective stress level during performance measured with visual analogue scales (VAS) on 100mm from zero intensity to maximal intensity. High stress levels are worse.

    Measured: 2 days

  3. Reaction time in Alertness task

    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.

    Measured: 2 days

  4. Sleepiness Score

    Karolinska Sleepiness Scale, Score between 1(extremely alert) to 9 (very sleepy, great effort to keep awake, fighting sleep)

    Measured: 2 days

  5. Pain Empathy Accuracy

    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.

    Measured: 2 days

  6. Pain Empathy D prime

    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))

    Measured: 2 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Nov 2022
  2. Study start8 Nov 2022
  3. Primary completion30 Jun 2023
  4. Study completion30 Jun 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Model description
Randomised Control Trial (RCT)
Masking
None (open label)
Enrolment
44 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05619081
Sponsor's protocol ID
R-NAP
Acronym
R-NAP
Status last verified
Nov 2025
First submitted
30 Sep 2022
Last updated
17 Nov 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 8731493
  • 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.

    PubMed 32382403
  • 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.

    PubMed 32516181
  • 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.

    PubMed 31352036
  • Landrigan CP, Rothschild JM, Cronin JW, Kaushal R, Burdick E, Katz JT, Lilly CM, Stone PH, Lockley SW, Bates DW, Czeisler CA; New Collective Author. 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.

    PubMed 15509817
  • 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.

    PubMed 12766642
  • 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.

    PubMed 28882740
  • 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.

    PubMed 32492169
  • 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.

    PubMed 34639511
  • Schmidt L, Genty F, Delaire T, Valero B, Rey I, Galan L, Mairet-Mabboux S, Douplat M, Schlatter S, Rimmele T, Mazza S, Lilot M. Clinical Performance in Critical Care Simulation under Sleep Deprivation: Effects of Power Napping in the Recovery Napping Protocol for Anesthesiologist Performance (R-NAP) Randomized Controlled Trial. Anesthesiology. 2026 Aug 17. doi: 10.1097/ALN.0000000000006135. Online ahead of print.

    PubMed 42101030

Questions about this trial

What is this clinical trial studying?

A study testing POWERNAP in people with Sleep Deprivation and Critical Incident, run by Claude Bernard University at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Score of technical clinical performance via rating grids (time frame: 2 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05619081, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Nov 2025.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in