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Mental FatigueNap&RunNCT07580131

The Restorative Role of Daytime Naps in Mentally Fatigued Endurance Athletes

A study testing Mental Fatigue Induction Protocol and Daytime Nap in people with Mental Fatigue and Sleep, run by L.U.de.S. Sagl at 1 site in Italy.

Completed

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

Official record
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Trial summary

This randomized, counterbalanced crossover study investigated whether a 30-minute daytime nap can mitigate the effects of experimentally induced mental fatigue in amateur master endurance athletes. Read more about this study

Who is it for?
Ages 28 to 50 years, men only
Conditions the study is for
Mental Fatigue, Sleep, Endurance Exercise
What is being tested?
Mental Fatigue Induction Protocol and Daytime Nap
Could I receive a placebo?
No, everyone receives an active treatment
How many people
11 participants
Where
1 siteItaly
Study dates
11 Jan 2021to 15 May 2021
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 28 to 50 years
  • Men only
  • No healthy volunteers
  • Adult

Who may be able to join

  • Male amateur master endurance athletes
  • Age between 28 and 50 years
  • Peak oxygen uptake (VO₂peak) ≥55 mL·kg-¹·min-¹
  • Habitual nocturnal sleep duration of at least 7 hours
  • Able and willing to complete both experimental sessions and daytime nap procedures

Who cannot join

  • Diagnosed medical condition or injury
  • Diagnosed sleep disorder
  • Use of medications or supplements affecting sleep or cognition, including melatonin
  • Habitual sleep duration of less than 7 hours per night
  • Inability to nap during the experimental sessions

Trial locations and contacts

1 site in 1 country.

Italy1 site

  • University of Milan

    Milan

Other trials in Italy

About this study

Official title: The Restorative Role of Daytime Naps in Mentally Fatigued Endurance Athletes: a Randomized Controlled Trial

This randomized, counterbalanced crossover study investigated whether a 30-minute daytime nap can mitigate the effects of experimentally induced mental fatigue in amateur master endurance athletes. Male athletes completed two home-based experimental sessions separated by one week: a mental fatigue condition, in which a 30-minute cognitively demanding task battery preceded the nap, and a control condition, in which participants took only the nap. Sleep parameters during the nap were monitored by wrist actigraphy, and perceived sleep quality was assessed after awakening. Subjective sleepiness, perceived mental fatigue, and cognitive performance were evaluated before the nap, immediately after the nap, and/or 30 minutes after the nap.

The study examined whether mental fatigue influenced nap characteristics and whether the nap improved recovery-related outcomes. The main outcomes included actigraphy-derived nap parameters, perceived sleep quality, sleepiness assessed with the Karolinska Sleepiness Scale, perceived mental fatigue assessed using a visual analogue scale, and cognitive performance assessed with a Flanker task.

Being tested
Mental Fatigue Induction Protocol, Daytime Nap
Keywords
Sleep, Actigraphy, Napping, Recovery, Running
Medical subject headings
Mental Fatigue

What participants receive

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

  • Mental Fatigue Induction ProtocolBehavioural

    Participants completed a 30-minute computerized cognitive task battery designed to induce mental fatigue before the daytime nap. The protocol consisted of three consecutive 10-minute cognitively demanding tasks: a Flanker task, a memory task, and a Stroop task.

  • Daytime NapBehavioural

    Participants took a 30-minute daytime nap at home between 14:00 and 15:00, at least one hour after lunch, in a quiet and dimly lit room. Nap characteristics were monitored using wrist actigraphy, and perceived sleep quality was assessed after awakening.

Study groups in NCT07580131
Study groupRoleWhat they receive
Mental Fatigue + Daytime NapExperimentalParticipants completed a 30-minute mental fatigue induction protocol consisting of cognitively demanding tasks, followed by a 30-minute daytime nap performed at home between 14:00 and 15:00. Subjective sleepiness, perceived mental fatigue, nap characteristics, perceived sleep quality, and cognitive performance were assessed before and/or after the nap.
Receives: Behavioral: Mental Fatigue Induction Protocol; Behavioral: Daytime Nap
Daytime Nap ControlActive comparatorParticipants completed the control condition consisting of a 30-minute daytime nap performed at home between 14:00 and 15:00, without the preceding mental fatigue induction protocol. Subjective sleepiness, perceived mental fatigue, nap characteristics, perceived sleep quality, and cognitive performance were assessed before and/or after the nap.
Receives: Behavioral: Daytime Nap

What is being measured

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

  1. Perceived mental fatigue

    Perceived mental fatigue was assessed using a 100-mm visual analogue scale for mental fatigue (VAS-MF), anchored from 0-mm "No mental fatigue" to 100-mm "Maximum mental fatigue." Participants marked the point that best represented their perceived level of mental fatigue.

    Measured: Before the nap, immediately after the nap, and 30 minutes after the nap in each experimental condition.

Secondary outcomes (9)

  1. Subjective sleepiness

    Subjective sleepiness was assessed using the Karolinska Sleepiness Scale (KSS), a 9-point scale ranging from 1, "not sleepy at all," to 9, "extremely sleepy."

    Measured: Before the nap, immediately after the nap, and 30 minutes after the nap

  2. Flanker Task Reaction Time

    Accuracy during the computerized Flanker task was calculated as the percentage of correct responses and used as an indicator of executive function performance. Accuracy ranges from 0 to 100%.

    Measured: 30 minutes after the nap in each experimental condition.

  3. Perceived Nap Sleep Quality

    Perceived sleep quality after the nap was assessed using a 10-point Likert scale, from 0 to 10, with higher scores indicating better perceived sleep quality.

    Measured: Immediately after the nap in each experimental condition.

  4. Actigraphy-Derived nap start time

    Clock time at which the nap period begins, usually identified from the rest interval or sleep diary. Nap start time is expressed as clock time, using the 24-hour format.

    Measured: During the 30-minute daytime nap in each experimental condition.

  5. Actigraphy-Derived nap time in bed

    Total time spent in bed or within the defined nap/rest interval, from nap start time to nap end time. Values are expressed in minutes.

    Measured: During the 30-minute daytime nap in each experimental condition.

  6. Actigraphy-Derived nap total sleep time

    Total duration of epochs scored as sleep during the nap/rest interval. Values are expressed in minutes.

    Measured: During the 30-minute daytime nap in each experimental condition.

  7. Actigraphy-Derived nap sleep onset latency

    Time elapsed between nap start time and the first epoch scored as sleep. Values are expressed in minutes.

    Measured: During the 30-minute daytime nap in each experimental condition.

  8. Actigraphy-Derived nap sleep efficiency

    Sleep efficiency is expressed as a percentage, ranging from 0% to 100%, and is calculated as the ratio between total sleep time and time in bed multiplied by 100

    Measured: During the 30-minute daytime nap in each experimental condition.

  9. Actigraphy-Derived nap fragmentation index

    An index reflecting sleep disruption or restlessness, based on movement and short immobility bouts during the sleep period. Higher values indicate more fragmented sleep. Fragmentation index is expressed as a percentage from 0% to 100%

    Measured: During the 30-minute daytime nap in each experimental condition.

Timeline

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

  1. First posted12 May 2026
  2. Study start11 Jan 2021
  3. Primary completion15 May 2021
  4. Study completion15 May 2021

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
Treatment
Allocation
Randomised
Intervention model
Crossover
Model description
Participants completed a randomized, counterbalanced, crossover study consisting of two experimental conditions separated by a one-week washout period. In one condition, participants underwent a 30-minute mental fatigue induction protocol before a 30-minute daytime nap; in the control condition, participants completed the nap without the preceding mental fatigue protocol. Each participant served as his own control, and the order of conditions was randomized.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
11 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07580131
Sponsor's protocol ID
Nap&Run01
Acronym
Nap&Run
Status last verified
May 2026
First submitted
28 Apr 2026
Last updated
12 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Individual participant data will not be made publicly available. Data supporting the findings of this study may be available from the corresponding author upon reasonable request.

Publications

  • Kaida K, Takahashi M, Akerstedt T, Nakata A, Otsuka Y, Haratani T, Fukasawa K. Validation of the Karolinska sleepiness scale against performance and EEG variables. Clin Neurophysiol. 2006 Jul;117(7):1574-81. doi: 10.1016/j.clinph.2006.03.011. Epub 2006 May 6.

    PubMed 16679057

  • Marcora SM, Staiano W, Manning V. Mental fatigue impairs physical performance in humans. J Appl Physiol (1985). 2009 Mar;106(3):857-64. doi: 10.1152/japplphysiol.91324.2008. Epub 2009 Jan 8.

    PubMed 19131473

  • Macari M, Pela IR, Silva CA, Viana RS. Fever response induced by intravenous and intracerebroventricular injection of pyrogen in thyroidectomised and protein-calorie malnourished rabbits. Pflugers Arch. 1990 Jan;415(4):440-3. doi: 10.1007/BF00373621.

    PubMed 2107523

  • Mesas AE, Nunez de Arenas-Arroyo S, Martinez-Vizcaino V, Garrido-Miguel M, Fernandez-Rodriguez R, Bizzozero-Peroni B, Torres-Costoso AI. Is daytime napping an effective strategy to improve sport-related cognitive and physical performance and reduce fatigue? A systematic review and meta-analysis of randomised controlled trials. Br J Sports Med. 2023 Apr;57(7):417-426. doi: 10.1136/bjsports-2022-106355. Epub 2023 Jan 23.

    PubMed 36690376

  • Lastella M, Halson SL, Vitale JA, Memon AR, Vincent GE. To Nap or Not to Nap? A Systematic Review Evaluating Napping Behavior in Athletes and the Impact on Various Measures of Athletic Performance. Nat Sci Sleep. 2021 Jun 24;13:841-862. doi: 10.2147/NSS.S315556. eCollection 2021.

    PubMed 34194254

  • Van Cutsem J, Marcora S, De Pauw K, Bailey S, Meeusen R, Roelands B. The Effects of Mental Fatigue on Physical Performance: A Systematic Review. Sports Med. 2017 Aug;47(8):1569-1588. doi: 10.1007/s40279-016-0672-0.

    PubMed 28044281

Questions about this trial

What is this clinical trial studying?

A study testing Mental Fatigue Induction Protocol and Daytime Nap in people with Mental Fatigue and Sleep, run by L.U.de.S. Sagl at 1 site in Italy.

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 5 inclusion and 5 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 12 May 2026. 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 Italy. 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?

Perceived mental fatigue (time frame: Before the nap, immediately after the nap, and 30 minutes after the nap in each experimental condition.). 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 NCT07580131, which also lists 6 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 12 May 2026.

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