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

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

Status
Enrolling by invitation
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07495189
Acronym
mechanisms
Enrollment
200
Registered
2026-03-27
Start date
2024-10-01
Completion date
2027-10-01
Last updated
2026-03-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sleep Disorder Insomnia Chronic

Keywords

sleep disorder, Heart-brain axis, magnetoencephalography, magnetocardiography

Brief summary

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.

Interventions

OTHERelectrocardiographic/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_TESTambulatory electrocardiogram

Subjects wore a dynamic ECG for 24 hours before the start of the tria

OTHERGeneral 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

OTHERscale 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

Sponsors

Qilu Hospital of Shandong University
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes

Inclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
High-Frequency Power of Heart Rate VariabilityBaseline (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).
Low-Frequency Power of Heart Rate Variability5-minute baseline; during each 3-minute musical stimulus; 5-minute post-stimulus baselineLow-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).
Magnetocardiographic Frequency-Domain ParametersA 5-minute baseline measurement; 5 different musical stimuli, each lasting 3 minutes; a 5-minute baseline measurementMagnetocardiographic 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.
Electroencephalographic Event-Related Potential ComponentsA 5-minute baseline measurement; responses during five different musical stimuli, each lasting 3 minutes; a second 5-minute baseline measurementElectroencephalographic Event-Related Potential Components - measured in microvolts (µV) to quantify electrical brain response amplitudes and latencies in milliseconds during cognitive and emotional processing tasks.
Electroencephalographic Oscillatory PowerA 5-minute baseline measurement; responses during five different musical stimuli, each lasting 3 minutes; a second 5-minute baseline measurementElectroencephalographic Oscillatory Power - measured in decibels (dB) to assess rhythmic neural activity power within specific frequency bands including alpha, beta, theta, gamma, and delta oscillations.
Magnetoencephalographic Event-Related Field ComponentsA 5-minute baseline measurement; responses during five different musical stimuli, each lasting 3 minutes; a second 5-minute baseline measurementMagnetoencephalographic Event-Related Field Components - measured in Tesla (T) to evaluate magnetic brain response amplitudes and latencies in milliseconds during cognitive and emotional processing tasks.
Magnetoencephalographic Oscillatory PowerA 5-minute baseline measurement; responses during five different musical stimuli, each lasting 3 minutes; a second 5-minute baseline measurementMagnetoencephalographic Oscillatory Power - measured in decibels (dB) to quantify magnetic field oscillations power within specific frequency bands including alpha, beta, theta, gamma, and delta rhythms.

Secondary

MeasureTime frameDescription
Demographic CharacteristicsBefore the experiment beginsA 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.
Pittsburgh Sleep Quality Index (PSQI)Before the experiment beginsPittsburgh 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.
Hamilton Anxiety Rating Scale (HAMA)Before the experiment beginsHamilton 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.
Hamilton Depression Rating Scale (HAMD)Before the experiment beginsHamilton 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.
Montreal Cognitive Assessment (MoCA)Before the experiment beginsMontreal Cognitive Assessment (MoCA) - measured in scores to evaluate cognitive function across multiple domains, with higher scores indicating better cognitive performance.
Mini-Mental State Examination (MMSE)Before the experiment beginsMini-Mental State Examination (MMSE) - measured in scores to assess global cognitive function, with higher scores representing better cognitive performance.
Magnetocardiographic Signal Amplitude5-minute baseline; during each 3-minute musical stimulus; 5-minute post-stimulus baselinePeak magnetic signal amplitude of cardiac activity measured using magnetocardiography during baseline and musical stimulation periods, reported in Tesla (T).
Standard Deviation of Normal-to-Normal Intervals5-minute baseline; during each 3-minute musical stimulus; 5-minute post-stimulus baselineStandard 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).
Magnetocardiographic Signal Duration5-minute baseline; during each 3-minute musical stimulus; 5-minute post-stimulus baselineDuration of magnetocardiographic cardiac waveform measured during baseline and musical stimulation periods, reported in milliseconds (ms).
Magnetocardiographic Waveform Field Strength5-minute baseline; during each 3-minute musical stimulus; 5-minute post-stimulus baselineMagnetic field strength of specific cardiac waveform components measured during baseline and musical stimulation periods, reported in Tesla (T).

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 28, 2026