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Набор скоро начнётся NCT07409883

Association Between Slow Wave Activity and Sleep Inertia

— Наблюдательное Sleep, Slow-wave Sleep, Sleep Enhancement, Sleep Optimization Sleep Inertia Night Shift Work

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Nap intervention.
Кому может быть актуально
Состояния в реестре: Sleep, Slow-wave Sleep, Sleep Enhancement, Sleep Optimization, Sleep Inertia, Night Shift Work. Базовые параметры: 18 лет — 80 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Таиланд
Следующий шаг
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Официальное название

Association Between Slow Wave Activity and Sleep Inertia in Nighttime Simulated Naps: An Observational Study With Nap Intervention

Обзор

Observational study: The goal of this observational study is to learn about the association between slow wave activity before awakening and post-awakening psychomotor vigilance task in time-fixed, 2-hour, simulated night naps in healthy individuals. The main question aims to answer is: Is the quantity of slow wave activity immediately before awakening associated with post-awakening psychomotor vigilance task metrics when awakened after 2-hour nap at night?

Подробное описание

Sleepiness and fatigue are common complaints among shift workers, especially night shift workers. Napping interventions before a work shift have been reported to increase alertness and reduce accidents. However, naps may also result in impaired cognition for a brief period immediately after awakening, known as "sleep inertia", which can be particularly problematic in on-call settings and may require a worker to delay the return to work for up to about 30 minutes after waking. Although, nap duration less than 30 minutes, theoretically, may produce less intense sleep inertia. However, evidence regarding nap duration aiming to mitigate sleepiness and fatigue is mixing. We thus aimed to investigate the association between slow wave activity (SWA) assessed by EEG power spectral analysis during the last 10 minutes before awakening and 10-minute psychomotor vigilance test (PVT) immediately after awakening and 30 minutes after awakening in healthy participants on simulated night shift scenarios.

Вмешательства

  • Поведенческое Nap intervention
    Nap intervention is the protocol that allows the participant to sleep from 11:00 PM to 2:00 AM, then woken up.

Первичные конечные точки

  • psychomotor vigilance test (PVT) [Срок оценки: Psychomotor vigilance test (PVT) will be assessed 2 times: 1) immediately after awakening, and 2) at 30 minutes after awakening.]

Критерии участия

Критерии включения

  • Age between 18 and 60 years
  • History of appropriate sleep duration at least 6 hours/night for a minimum of 2 weeks assessed by sleep diary before the trial

Критерии исключения

  • STOP-BANG ≥3 or previous diagnosis of obstructive sleep apnea
  • Presence of restless legs syndrome as assessed with IRLSSG criteria
  • Presence of depression as assessed by HADS (Exclude participants with HADS-Depression sub-scale score ≥8 (possible depression)
  • History of irregular work hours or shift work within 2 weeks
  • Use of sedative/hypnotic medications on a regular-basis (3 days/week or above)
  • History of epilepsy and brain tumor

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения
Только случаи

Центры проведения

Таиланд · 1 центр
  • Faculty of Engineering, Mahidol University — Nakhon Pathom

Публикации

  • Signal TL, van den Berg MJ, Mulrine HM, Gander PH. Duration of sleep inertia after napping during simulated night work and in extended operations. Chronobiol Int. 2012 Jul;29(6):769-79. doi: 10.3109/07420528.2012.686547. PMID 22734577
  • Achermann P, Werth E, Dijk DJ, Borbely AA. Time course of sleep inertia after nighttime and daytime sleep episodes. Arch Ital Biol. 1995 Dec;134(1):109-19. PMID 8919196
  • Hilditch CJ, McHill AW. Sleep inertia: current insights. Nat Sci Sleep. 2019 Aug 22;11:155-165. doi: 10.2147/NSS.S188911. eCollection 2019. PMID 31692489
  • Tassi P, Bonnefond A, Engasser O, Hoeft A, Eschenlauer R, Muzet A. EEG spectral power and cognitive performance during sleep inertia: the effect of normal sleep duration and partial sleep deprivation. Physiol Behav. 2006 Jan 30;87(1):177-84. doi: 10.1016/j.physbeh.2005.09.017. Epub 2005 Nov 21. PMID 16303153
  • Dinges D, Orne M, Orne E. Assessing performance upon abrupt awakening from nap during quasi-continuous operations. Behavior Research Methods. 1985;17:37-45
  • Jewett ME, Wyatt JK, Ritz-De Cecco A, Khalsa SB, Dijk DJ, Czeisler CA; New Collective Author. Time course of sleep inertia dissipation in human performance and alertness. J Sleep Res. 1999 Mar;8(1):1-8. doi: 10.1111/j.1365-2869.1999.00128.x. PMID 10188130
  • Tassi P, Muzet A. Sleep inertia. Sleep Med Rev. 2000 Aug;4(4):341-353. doi: 10.1053/smrv.2000.0098. PMID 12531174
  • Patterson PD, Liszka MK, Mcilvaine QS, Nong L, Weaver MD, Turner RL, Platt TE, Opitz SE, Guyette FX, Martin-Gill C, Weiss LS, Buysse DJ, Callaway CW. Does the evidence support brief (</=30-mins), moderate (31-60-mins), or long duration naps (61+ mins) on the night shift? A systematic review. Sleep Med Rev. 2021 Oct;59:101509. doi: 10.1016/j.smrv.2021.101509. Epub 2021 May 19. PMID 34116386

Идентификаторы

NCT: NCT07409883 · MURA2026/53

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗