Набор по приглашению NCT07495189

A Study of the Mechanisms by Which Mood and Sleep Disorders Interact

— Наблюдательное Sleep Disorder Insomnia Chronic

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: electrocardiographic/magnetic and electroencephalographic/magnetic monitoring data, ambulatory electrocardiogram, General clinical information, scale assessment.
Кому может быть актуально: Состояния в реестре: Sleep Disorder Insomnia Chronic. 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: Китай
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Обзор

The main purpose of the study is to explore the mechanisms by which mood and sleep disorders interact. The exploratory aim of this study is to discover the relationship between ECG/MCG and EEG/MEG characteristics and mood and sleep disorders and to discover the correlation between cardio-brain monitoring and to explore the mechanisms by which mood and sleep disorders influence each other.

Вмешательства

Другое electrocardiographic/magnetic and electroencephalographic/magnetic monitoring data
First, a 5-minute baseline measurement is performed, and then, 5 different musical stimuli are played in turn, each lasting for 3 minutes. After each music is played, a 1-minute break is arranged. After the last musical stimulation, a 5-minute end measurement is performed to record the final physiological indicators.
Диагностический тест ambulatory electrocardiogram
Subjects wore a dynamic ECG for 24 hours before the start of the tria
Другое General clinical information
General situation collection: Detailed baseline data collection for all participants, including basic demographic characteristics such as age, gender, education level, health status, sleep and lifestyle
Другое scale assessment
Measure Pittsburgh Sleep Quality Index (PSQI), Insomnia Severity Index (ISI), Montreal Cognitive Assessment Scale (MoCA), Simple Intelligent Mental State Check Scale (MMSE), Hamilton Anxiety Scale (HAMA), Hamilton Depression Scale (HAMD), Epworth Drowsiness Scale (ESS), SF-36 Quality of Life Tables and other related scale information

Первичные конечные точки

High-Frequency Power of Heart Rate Variability [Срок оценки: Baseline (5 minutes); during each 3-minute musical stimulus; post-stimulus baseline (5 minutes)]
Low-Frequency Power of Heart Rate Variability [Срок оценки: 5-minute baseline; during each 3-minute musical stimulus; 5-minute post-stimulus baseline]
Magnetocardiographic Frequency-Domain Parameters [Срок оценки: A 5-minute baseline measurement; 5 different musical stimuli, each lasting 3 minutes; a 5-minute baseline measurement]
Electroencephalographic Event-Related Potential Components [Срок оценки: A 5-minute baseline measurement; responses during five different musical stimuli, each lasting 3 minutes; a second 5-minute baseline measurement]
Electroencephalographic Oscillatory Power [Срок оценки: A 5-minute baseline measurement; responses during five different musical stimuli, each lasting 3 minutes; a second 5-minute baseline measurement]
Magnetoencephalographic Event-Related Field Components [Срок оценки: A 5-minute baseline measurement; responses during five different musical stimuli, each lasting 3 minutes; a second 5-minute baseline measurement]
Magnetoencephalographic Oscillatory Power [Срок оценки: A 5-minute baseline measurement; responses during five different musical stimuli, each lasting 3 minutes; a second 5-minute baseline measurement]

Вторичные конечные точки (10)

Demographic Characteristics [Срок оценки: Before the experiment begins]
Pittsburgh Sleep Quality Index (PSQI) [Срок оценки: Before the experiment begins]
Hamilton Anxiety Rating Scale (HAMA) [Срок оценки: Before the experiment begins]
Hamilton Depression Rating Scale (HAMD) [Срок оценки: Before the experiment begins]
Montreal Cognitive Assessment (MoCA) [Срок оценки: Before the experiment begins]
Mini-Mental State Examination (MMSE) [Срок оценки: Before the experiment begins]
Magnetocardiographic Signal Amplitude [Срок оценки: 5-minute baseline; during each 3-minute musical stimulus; 5-minute post-stimulus baseline]
Standard Deviation of Normal-to-Normal Intervals [Срок оценки: 5-minute baseline; during each 3-minute musical stimulus; 5-minute post-stimulus baseline]
Magnetocardiographic Signal Duration [Срок оценки: 5-minute baseline; during each 3-minute musical stimulus; 5-minute post-stimulus baseline]
Magnetocardiographic Waveform Field Strength [Срок оценки: 5-minute baseline; during each 3-minute musical stimulus; 5-minute post-stimulus baseline]