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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mood disorder with insomnia group |
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| Primary insomnia group | ①meet the above diagnostic criteria for insomnia
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| Normal healthy group | physical, mental, psychological and social relations are in perfect condition |
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| Mood disorder without insomnia group |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| electrocardiographic/magnetic and electroencephalographic/magnetic monitoring data | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| High-Frequency Power of Heart Rate Variability | 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). | Baseline (5 minutes); during each 3-minute musical stimulus; post-stimulus baseline (5 minutes) |
| Low-Frequency Power of Heart Rate Variability | 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). | 5-minute baseline; during each 3-minute musical stimulus; 5-minute post-stimulus baseline |
| Magnetocardiographic Frequency-Domain Parameters | 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. | A 5-minute baseline measurement; 5 different musical stimuli, each lasting 3 minutes; a 5-minute baseline measurement |
| Electroencephalographic Event-Related Potential Components | 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. | A 5-minute baseline measurement; responses during five different musical stimuli, each lasting 3 minutes; a second 5-minute baseline measurement |
| Electroencephalographic Oscillatory Power | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Demographic Characteristics | 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. | Before the experiment begins |
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1.Normal health group2.Mood disorders with insomnia group3.Mood disorders without insomnia group4.Primary insomnia group
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Meet the above diagnostic criteria for Normal health group: physical, mental, psychological and social relations are in perfect condition
• Mood disorders with insomnia group: Meet the above diagnostic criteria for insomnia Age 18-80 years old PSQI > 5, ISI > 7, HAMA > 7 and/or HAMD ≥ 7 No communication barriers Signed informed consent form
• Mood disorders without insomnia group: Do not meet the above diagnostic criteria for insomnia Age 18-80 years old PSQI ≤ 5, ISI ≤ 7, HAMA > 7 and/or HAMD ≥ 7 No communication barriers Signed informed consent form
• Primary insomnia group: Meet the above diagnostic criteria for insomnia Do not meet the above diagnostic criteria for mood disorders Age 18-80 years old PSQI > 5, ISI > 7, HAMA ≤ 7, and HAMD < 7 No communication barriers Sign the informed consent form
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing University of Aeronautics and Astronautics | Jinan | Shandong | China | |||
| Qilu Hospital of Shandong University |
2024-10Network sharing
2024.10-2027-10
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Oct 11, 2024 | Jul 24, 2025 |
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| ambulatory electrocardiogram | Diagnostic Test | Subjects wore a dynamic ECG for 24 hours before the start of the tria |
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| General clinical information | Other | 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 |
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| scale assessment | Other | 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 |
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| 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 | 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. | A 5-minute baseline measurement; responses during five different musical stimuli, each lasting 3 minutes; a second 5-minute baseline measurement |
| Magnetoencephalographic Oscillatory Power | 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. | A 5-minute baseline measurement; responses during five different musical stimuli, each lasting 3 minutes; a second 5-minute baseline measurement |
| Pittsburgh Sleep Quality Index (PSQI) |
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. |
| Before the experiment begins |
| Hamilton Anxiety Rating Scale (HAMA) | 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. | Before the experiment begins |
| Hamilton Depression Rating Scale (HAMD) | 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. | Before the experiment begins |
| Montreal Cognitive Assessment (MoCA) | Montreal Cognitive Assessment (MoCA) - measured in scores to evaluate cognitive function across multiple domains, with higher scores indicating better cognitive performance. | Before the experiment begins |
| Mini-Mental State Examination (MMSE) | Mini-Mental State Examination (MMSE) - measured in scores to assess global cognitive function, with higher scores representing better cognitive performance. | Before the experiment begins |
| Magnetocardiographic Signal Amplitude | Peak magnetic signal amplitude of cardiac activity measured using magnetocardiography during baseline and musical stimulation periods, reported in Tesla (T). | 5-minute baseline; during each 3-minute musical stimulus; 5-minute post-stimulus baseline |
| Standard Deviation of Normal-to-Normal Intervals | 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). | 5-minute baseline; during each 3-minute musical stimulus; 5-minute post-stimulus baseline |
| Magnetocardiographic Signal Duration | Duration of magnetocardiographic cardiac waveform measured during baseline and musical stimulation periods, reported in milliseconds (ms). | 5-minute baseline; during each 3-minute musical stimulus; 5-minute post-stimulus baseline |
| Magnetocardiographic Waveform Field Strength | Magnetic field strength of specific cardiac waveform components measured during baseline and musical stimulation periods, reported in Tesla (T). | 5-minute baseline; during each 3-minute musical stimulus; 5-minute post-stimulus baseline |
| Jinan |
| Shandong |
| China |
| Prot_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Oct 11, 2024 | Jul 28, 2025 | ICF_001.pdf |
| ID | Term |
|---|---|
| D007319 | Sleep Initiation and Maintenance Disorders |
| D012893 | Sleep Wake Disorders |
| ID | Term |
|---|---|
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D009422 | Nervous System Diseases |
| D001523 | Mental Disorders |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D015716 | Electrocardiography, Ambulatory |
| ID | Term |
|---|---|
| D004562 | Electrocardiography |
| D006334 | Heart Function Tests |
| D003935 | Diagnostic Techniques, Cardiovascular |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D004568 | Electrodiagnosis |
| D018670 | Monitoring, Ambulatory |
| D008991 | Monitoring, Physiologic |
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