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

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Sleep Disorder Insomnia Chronic
• Intervention / Treatment: Other: electrocardiographic/magnetic and electroencephalographic/magnetic monitoring data; Diagnostic test: ambulatory electrocardiogram; Other: General clinical information; Other: scale assessment

• Study Type: Observational
• Enrollment (Estimated): 200

Contacts and Locations

Study Locations

• China
  • Shandong
    • Jinan, Shandong, China
      • Qilu Hospital of Shandong University
    • Jinan, Shandong, China
      • Beijing University of Aeronautics and Astronautics

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

• Normal health group: physical, mental, psychological and social relations are in perfect condition
• Mood disorders with insomnia group:

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

Description

1.Normal health group2.Mood disorders with insomnia group3.Mood disorders without insomnia group4.Primary insomnia group

Study Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Mood disorder with insomnia group; Meet the above diagnostic criteria for insomniaAge 18-80 years oldPSQI>5, ISI>7, HAMA>7 and/or HAMD≥7 ④No communication barriers ⑤Signed informed consent form	Other: 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.; Diagnostic test: ambulatory electrocardiogram; Subjects wore a dynamic ECG for 24 hours before the start of the tria; Other: 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; Other: 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
Primary insomnia group; ①meet the above diagnostic criteria for insomnia; don't meet the above diagnostic criteria for mood disordersage 18～80 years oldPSQI>5, ISI>7, HAMA≤7, and HAMD<7 ⑤no communication barriers ⑥sign the informed consent form	Other: 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.; Diagnostic test: ambulatory electrocardiogram; Subjects wore a dynamic ECG for 24 hours before the start of the tria; Other: 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; Other: 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
Normal healthy group; physical, mental, psychological and social relations are in perfect condition	Other: 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.; Diagnostic test: ambulatory electrocardiogram; Subjects wore a dynamic ECG for 24 hours before the start of the tria; Other: 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; Other: 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
Mood disorder without insomnia group; do not meet the above diagnostic criteria for insomnia ② age 18 - 80 yearsPSQI ≤ 5, ISI ≤ 7, HAMA > 7 and/or HAMD ≥ 7 ④ no communication barriers ⑤ signed informed consent form	Other: 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.; Diagnostic test: ambulatory electrocardiogram; Subjects wore a dynamic ECG for 24 hours before the start of the tria; Other: 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; Other: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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.	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

Secondary Outcome Measures

Outcome Measure	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
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

Collaborators and Investigators

• Sponsor: Qilu Hospital of Shandong University

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2024
• Primary Completion (Estimated): August 31, 2027
• Study Completion (Estimated): October 1, 2027

Study Registration Dates

• First Submitted: July 28, 2025
• First Submitted That Met QC Criteria: March 22, 2026
• First Posted (Actual): March 27, 2026

Study Record Updates

• Last Update Posted (Actual): March 27, 2026
• Last Update Submitted That Met QC Criteria: March 22, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: sleep disorder; magnetoencephalography; magnetocardiography; Heart-brain axis
• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Mental Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Sleep Initiation and Maintenance Disorders; Sleep Wake Disorders; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Cardiovascular; Heart Function Tests; Electrodiagnosis; Monitoring, Physiologic; Electrocardiography; Monitoring, Ambulatory; Electrocardiography, Ambulatory
• Other Study ID Numbers: KYLL-202408-063-1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 2024-10Network sharing
• IPD Sharing Time Frame: 2024.10-2027-10
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No