NCT07580131

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
11

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2021

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

Study Start

First participant enrolled

January 11, 2021

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 15, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 15, 2021

Completed
5 years until next milestone

First Submitted

Initial submission to the registry

April 28, 2026

Completed
14 days until next milestone

First Posted

Study publicly available on registry

May 12, 2026

Completed
Last Updated

May 12, 2026

Status Verified

May 1, 2026

Enrollment Period

4 months

First QC Date

April 28, 2026

Last Update Submit

May 5, 2026

Conditions

Keywords

SleepActigraphyNappingRecoveryRunning

Outcome Measures

Primary Outcomes (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.

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

Secondary Outcomes (9)

  • Subjective sleepiness

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

  • Flanker Task Reaction Time

    30 minutes after the nap in each experimental condition.

  • Perceived Nap Sleep Quality

    Immediately after the nap in each experimental condition.

  • Actigraphy-Derived nap start time

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

  • Actigraphy-Derived nap time in bed

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

  • +4 more secondary outcomes

Study Arms (2)

Mental Fatigue + Daytime Nap

EXPERIMENTAL

Participants 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.

Behavioral: Mental Fatigue Induction ProtocolBehavioral: Daytime Nap

Daytime Nap Control

ACTIVE COMPARATOR

Participants 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.

Behavioral: Daytime Nap

Interventions

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.

Mental Fatigue + Daytime Nap
Daytime NapBEHAVIORAL

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.

Daytime Nap ControlMental Fatigue + Daytime Nap

Eligibility Criteria

Age28 Years - 50 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Milan

Milan, Italy

Location

Related Publications (6)

  • 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.

    PMID: 16679057BACKGROUND
  • 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.

    PMID: 19131473BACKGROUND
  • 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.

    PMID: 2107523BACKGROUND
  • 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.

    PMID: 36690376BACKGROUND
  • 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.

    PMID: 34194254BACKGROUND
  • 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.

    PMID: 28044281BACKGROUND

MeSH Terms

Conditions

Mental Fatigue

Condition Hierarchy (Ancestors)

FatigueSigns and SymptomsPathological Conditions, Signs and SymptomsBehavioral SymptomsBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
The researcher responsible for data processing and statistical analyses was blinded to condition allocation. Due to the nature of the intervention, participants and the researcher supervising the experimental sessions could not be blinded.
Purpose
TREATMENT
Intervention Model
CROSSOVER
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor, Group Head

Study Record Dates

First Submitted

April 28, 2026

First Posted

May 12, 2026

Study Start

January 11, 2021

Primary Completion

May 15, 2021

Study Completion

May 15, 2021

Last Updated

May 12, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share

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.

Locations