- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT07580131
The Restorative Role of Daytime Naps in Mentally Fatigued Endurance Athletes (Nap&Run)
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.
Visão geral do estudo
Status
Intervenção / Tratamento
Tipo de estudo
Inscrição (Real)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
-
-
-
Milan, Itália
- University of Milan
-
-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
Aceita Voluntários Saudáveis
Descrição
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição cruzada
- Mascaramento: Solteiro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Experimental: Mental Fatigue + Daytime Nap
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.
|
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.
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.
|
|
Comparador Ativo: Daytime Nap Control
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.
|
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.
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Perceived mental fatigue
Prazo: Before the nap, immediately after the nap, and 30 minutes after the nap in each experimental condition.
|
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.
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Subjective sleepiness
Prazo: Before the nap, immediately after the nap, and 30 minutes after the nap
|
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."
|
Before the nap, immediately after the nap, and 30 minutes after the nap
|
|
Flanker Task Reaction Time
Prazo: 30 minutes after the nap in each experimental condition.
|
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%.
|
30 minutes after the nap in each experimental condition.
|
|
Perceived Nap Sleep Quality
Prazo: Immediately after the nap in each experimental condition.
|
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.
|
Immediately after the nap in each experimental condition.
|
|
Actigraphy-Derived nap start time
Prazo: During the 30-minute daytime nap in each experimental condition.
|
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.
|
During the 30-minute daytime nap in each experimental condition.
|
|
Actigraphy-Derived nap time in bed
Prazo: During the 30-minute daytime nap in each experimental condition.
|
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.
|
During the 30-minute daytime nap in each experimental condition.
|
|
Actigraphy-Derived nap total sleep time
Prazo: During the 30-minute daytime nap in each experimental condition.
|
Total duration of epochs scored as sleep during the nap/rest interval.
Values are expressed in minutes.
|
During the 30-minute daytime nap in each experimental condition.
|
|
Actigraphy-Derived nap sleep onset latency
Prazo: During the 30-minute daytime nap in each experimental condition.
|
Time elapsed between nap start time and the first epoch scored as sleep.
Values are expressed in minutes.
|
During the 30-minute daytime nap in each experimental condition.
|
|
Actigraphy-Derived nap sleep efficiency
Prazo: During the 30-minute daytime nap in each experimental condition.
|
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
|
During the 30-minute daytime nap in each experimental condition.
|
|
Actigraphy-Derived nap fragmentation index
Prazo: During the 30-minute daytime nap in each experimental condition.
|
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%
|
During the 30-minute daytime nap in each experimental condition.
|
Colaboradores e Investigadores
Patrocinador
Publicações e links úteis
Publicações Gerais
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- Nap&Run01
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Descrição do plano IPD
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .