NCT Number: NCT07495189
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.
Interested in participating?
Request Info18 year–80 year
All sexes
Observational
Beijing University of Aeronautics and Astronautics, Jinan, Shandong, China
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
1.Normal health group2.Mood disorders with insomnia group3.Mood disorders without insomnia group4.Primary insomnia group
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.
Subjects wore a dynamic ECG for 24 hours before the start of the tria
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
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
Time frame: Baseline (5 minutes); during each 3-minute musical stimulus; post-stimulus baseline (5 minutes)
High-frequency power component of heart rate variability (HF-HRV) derived from electrocardiographic spectral analysis, reflecting parasympathetic (vagal) activity. HF-HRV is reported in milliseconds squared (ms²).
Time frame: 5-minute baseline; during each 3-minute musical stimulus; 5-minute post-stimulus baseline
Low-frequency power component of heart rate variability derived from electrocardiographic spectral analysis during baseline and musical stimulation periods, reflecting combined sympathetic and parasympathetic modulation, reported in milliseconds squared (ms²).
Time frame: A 5-minute baseline measurement; 5 different musical stimuli, each lasting 3 minutes; a 5-minute baseline measurement
Magnetocardiographic Frequency-Domain Parameters - measured in Tesla squared per Hertz (T²/Hz) to analyze spectral properties of cardiac magnetic signals, including power spectral density and energy distribution across frequency bands.
Time frame: A 5-minute baseline measurement; responses during five different musical stimuli, each lasting 3 minutes; a second 5-minute baseline measurement
Electroencephalographic Event-Related Potential Components - measured in microvolts (µV) to quantify electrical brain response amplitudes and latencies in milliseconds during cognitive and emotional processing tasks.
Time frame: A 5-minute baseline measurement; responses during five different musical stimuli, each lasting 3 minutes; a second 5-minute baseline measurement
Electroencephalographic Oscillatory Power - measured in decibels (dB) to assess rhythmic neural activity power within specific frequency bands including alpha, beta, theta, gamma, and delta oscillations.
Time frame: 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 - measured in Tesla (T) to evaluate magnetic brain response amplitudes and latencies in milliseconds during cognitive and emotional processing tasks.
Time frame: A 5-minute baseline measurement; responses during five different musical stimuli, each lasting 3 minutes; a second 5-minute baseline measurement
Magnetoencephalographic Oscillatory Power - measured in decibels (dB) to quantify magnetic field oscillations power within specific frequency bands including alpha, beta, theta, gamma, and delta rhythms.
Time frame: Before the experiment begins
A self-administered General Information Questionnaire was used to collect baseline demographic data, with age measured in years, sex categorized as male or female, and educational level quantified as the total number of years of formal education completed.
Time frame: Before the experiment begins
Pittsburgh Sleep Quality Index (PSQI) - measured in scores to assess sleep quality, with scores ≥ 7 indicating clinically significant insomnia and higher scores representing poorer sleep quality.
Time frame: Before the experiment begins
Hamilton Anxiety Rating Scale (HAMA) - measured in scores to evaluate anxiety severity, with scores ≥ 14 suggesting probable anxiety symptoms and higher scores indicating more severe anxiety.
Time frame: Before the experiment begins
Hamilton Depression Rating Scale (HAMD) - measured in scores to assess depression severity, with scores ≥ 17 (or ≥ 8 for the 8-item version) suggesting probable depressive symptoms and higher scores representing more severe depression.
Time frame: Before the experiment begins
Montreal Cognitive Assessment (MoCA) - measured in scores to evaluate cognitive function across multiple domains, with higher scores indicating better cognitive performance.
Time frame: Before the experiment begins
Mini-Mental State Examination (MMSE) - measured in scores to assess global cognitive function, with higher scores representing better cognitive performance.
Time frame: 5-minute baseline; during each 3-minute musical stimulus; 5-minute post-stimulus baseline
Peak magnetic signal amplitude of cardiac activity measured using magnetocardiography during baseline and musical stimulation periods, reported in Tesla (T).
Time frame: 5-minute baseline; during each 3-minute musical stimulus; 5-minute post-stimulus baseline
Standard deviation of normal-to-normal (NN) R-R intervals derived from electrocardiographic recordings as a time-domain measure of overall heart rate variability, reported in milliseconds (ms).
Time frame: 5-minute baseline; during each 3-minute musical stimulus; 5-minute post-stimulus baseline
Duration of magnetocardiographic cardiac waveform measured during baseline and musical stimulation periods, reported in milliseconds (ms).
Time frame: 5-minute baseline; during each 3-minute musical stimulus; 5-minute post-stimulus baseline
Magnetic field strength of specific cardiac waveform components measured during baseline and musical stimulation periods, reported in Tesla (T).
Qilu Hospital of Shandong University
Other
Acronym: mechanisms
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