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Идёт набор NCT07438912

Mind After Midnight

Без фазы С лечением Suicidal Ideation Circadian Rhythm Disorders Sleep Deprivation Sleep Wake Disorders

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 Pressure Manipulation.
Кому может быть актуально
Состояния в реестре: Suicidal Ideation, Circadian Rhythm Disorders, Sleep Deprivation, Sleep Wake Disorders. Базовые параметры: 18 лет — 55 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 →

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Официальное название

The Mind After Midnight: Mechanistic Examination of Nocturnal Wakefulness as a Suicide Risk Factor

Обзор

This study examines whether wakefulness during the biological night (2:00-4:00 AM) is associated with increased negative mood, impaired decision-making, and suicidal thoughts. Adults with a history of suicidal ideation in the past six months will complete laboratory and home-based assessments under varying levels of sleep pressure. Participants will be evaluated during late-night wakefulness and under conditions of both higher and lower sleep pressure. The goal of the study is to better understand the biological and behavioral mechanisms that may contribute to elevated suicide risk during nocturnal wakefulness.

Подробное описание

Suicide risk is elevated during the biological night, particularly between 2:00 and 4:00 AM. Observational and epidemiologic data suggest that nocturnal wakefulness is associated with increased negative affect, impaired decision-making, and greater suicidal ideation. The "Mind After Midnight" hypothesis proposes that wakefulness during the biological night exposes individuals to a combination of circadian vulnerability and homeostatic sleep pressure that contributes to emotional and cognitive dysregulation.

This study will recruit approximately 90 adults with a history of suicidal ideation in the past six months. Participants will complete both home-based and laboratory-based procedures. Laboratory assessments will evaluate mood, hopelessness, suicidal ideation, impulsivity, and decision-making at different times of day, including 2:00-4:00 AM. To examine the role of homeostatic sleep pressure, participants will complete late-night assessments under two conditions: (1) high sleep pressure (remaining awake until 2:00 AM) and (2) low sleep pressure (sleeping and being awakened at 2:00 AM). Circadian factors will be assessed using behavioral measures and physiologic markers, including melatonin.

The goal of the study is to experimentally test whether nocturnal wakefulness contributes to suicide-associated cognitive and affective processes and to identify underlying chronobiological mechanisms.

Вмешательства

  • Поведенческое Sleep Pressure Manipulation
    Participants undergo an experimental manipulation of homeostatic sleep pressure involving controlled wakefulness or scheduled awakening during the biological night. Mood, suicidal ideation, impulsivity, and decision-making are assessed during overnight laboratory sessions.

Первичные конечные точки

  • Feelings of Hopelessness [Срок оценки: Visit 1(day 2, night 2), Visit 2 (day 2, night 2)]
  • Impaired Executive Function [Срок оценки: Visit 1(day 2, night 2), Visit 2 (day 2, night 2)]
  • Negative Mood [Срок оценки: Visit 1(day 2, night 2), Visit 2 (day 2, night 2)]

Критерии участия

Критерии включения

  • Age 18-55 years
  • History of suicidal ideation within the past 6 months
  • Habitual bedtime between 9:00 PM and 1:00 AM
  • Habitual wake time between 6:00 AM and 9:00 AM
  • Ability to provide informed consent

Критерии исключения

  • Current suicidal intent requiring immediate clinical intervention
  • Diagnosis of a primary sleep disorder (e.g., untreated obstructive sleep apnea, narcolepsy)
  • Bipolar disorder or psychotic disorder
  • Substance use disorder within the past 3 months
  • Use of medications that significantly affect sleep or circadian rhythms
  • Night shift work or transmeridian travel within the past month
  • Medical or neurological condition that would interfere with participation
  • Pregnancy

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Перекрёстный дизайн
Маскирование
Открытое
Основная цель
Фундаментальное исследование

Центры проведения

США · 1 центр
  • University of Arizona - Center for Sleep, Circadian, and Neuroscience Research — Tucson

Идентификаторы

NCT: NCT07438912 · R01MH135978

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗