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Идёт набор NCT05393830

The Effect of Sleep Loss on Emotion Regulation

Без фазы С лечением Sleep Insomnia Sleep Deprivation

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: Sleep Restriction.
Кому может быть актуально
Состояния в реестре: Sleep, Insomnia, Sleep Deprivation. Базовые параметры: 18 лет — 40 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
США
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

The Impact of Insufficient Sleep and Insomnia Disorder on Behavioral and Neural Markers of Emotion Regulation

Обзор

The study is designed to investigate the impact of three nights of sleep restricted to 4 hours per night, on the processing and regulation of emotional information compared to Insomnia Disorder and control. The investigators will address and attempt to answer two questions. (i) How do three nights of reduced sleep or a diagnosis of Insomnia Disorder affect the processing and regulation of emotional information compared to typical, undisturbed sleep? (ii) What overlapping and distinct neural mechanisms are engaged and associated with behavioral effects when attempting to process and regulate emotions in a sleep restricted state or with a clinical diagnosis of Insomnia Disorder? This study will investigate sleep's role in emotion processing and regulation. The findings will help further understanding of the role of sleep in healthy emotional functioning.

Подробное описание

Goal 1: How does sleep loss and clinical sleep disruption (i.e. Insomnia Disorder) impact emotion perception and emotion regulation? The investigators are interested in how chronic loss of sleep, either through artificially restricting sleep or clinically related sleep disturbance, impairs our ability to properly perceive and regulate our responses to emotional information using various emotion regulation strategies. There has been research on the effect of sleep loss on broad areas of cognition, such as attention, working memory, and reasoning ability, but the impact of long-term sleep loss on emotional processing and regulation remains largely unexplored. The investigators aim to characterize how sleep loss via experimentally reduced sleep in healthy control participants or clinical sleep disturbance in patients with Insomnia Disorder, affects the ability to accurately perceive emotion. Investigators will also investigate how it alters the intensity with which emotions are perceived, and the effect that these changes have on the ability to regulate emotional responses to these stimuli compared to healthy control participants that are allowed undisturbed sleep.

Goal 2: How are changes in subjective emotional responses reflected in the neural signal and psychophysiological measures? The investigators will utilize fMRI and measures of autonomic reactivity (heart rate and skin conductance) to characterize the neural and psychophysiological responses that are associated with behavioral changes following sleep restriction or in patients with Insomnia disorder compared to healthy sleep control participants.

Вмешательства

  • Поведенческое Sleep Restriction
    Three nights of sleep restricted to 4 hours per night.

Первичные конечные точки

  • Baseline Emotional Regulation Task with Strategy [Срок оценки: Day 1]
  • Baseline Emotional Regulation Task without Strategy [Срок оценки: Day 1]
  • Reassessment of the Emotional Regulation Task with Strategy Baseline behavioral ratings to emotional stimuli with or without emotion regulation strategies [Срок оценки: one test in a 3-6 day window]
  • Reassessment of the Emotional Regulation Task without Strategy Baseline behavioral ratings to emotional stimuli with or without emotion regulation strategies [Срок оценки: one test in a 3-6 day window]
Вторичные конечные точки (1)
  • Functional Magnetic Resonance Imaging (fMRI) [Срок оценки: one test in a 3-6 day window]

Критерии участия

Критерии включения

  • willing and able to follow the protocol
  • willing and able to meet inclusion criteria for fMRI scanning
  • willing to refrain from alcohol and recreational drugs for the duration of the protocol
  • normal or corrected to normal vision is required

Критерии исключения

  • left-handedness or ambidexterity
  • the use of any drugs that could affect either sleep or cognitive functioning (e.g., prescription sleeping pills or antidepressants)

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Нерандомизированное
Модель
Параллельные группы
Маскирование
Открытое
Основная цель
Фундаментальное исследование

Центры проведения

США · 1 центр
  • Beth Israel Deaconess Medical Center — Boston

Идентификаторы

NCT: NCT05393830 · 2022P000120

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗