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

NCT07495189 | Enrolling By Invitation DMC

• 1 other identifier: KYLL-202408-063-1
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 2

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.

Conditions

Sleep Disorder Insomnia Chronic

Keywords

sleep disorder; Heart-brain axis; magnetoencephalography; magnetocardiography

Outcome Measures

Primary Outcomes (7)

• 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 Outcomes (10)

• Demographic Characteristics

  Before the experiment begins

• Pittsburgh Sleep Quality Index (PSQI)

  Before the experiment begins

• Hamilton Anxiety Rating Scale (HAMA)

  Before the experiment begins

• Hamilton Depression Rating Scale (HAMD)

  Before the experiment begins

• Montreal Cognitive Assessment (MoCA)

  Before the experiment begins

Study Arms (4)

Mood disorder 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 ④No communication barriers ⑤Signed informed consent form

Other: electrocardiographic/magnetic and electroencephalographic/magnetic monitoring data; Diagnostic Test: ambulatory electrocardiogram; Other: General clinical information; Other: scale assessment

Primary insomnia group

①meet the above diagnostic criteria for insomnia * don't meet the above diagnostic criteria for mood disorders * age 18～80 years old * PSQI\>5, ISI\>7, HAMA≤7, and HAMD\<7 ⑤no communication barriers ⑥sign the informed consent form

Other: electrocardiographic/magnetic and electroencephalographic/magnetic monitoring data; Diagnostic Test: ambulatory electrocardiogram; Other: General clinical information; Other: scale assessment

Normal healthy group

physical, mental, psychological and social relations are in perfect condition

Other: electrocardiographic/magnetic and electroencephalographic/magnetic monitoring data; Diagnostic Test: ambulatory electrocardiogram; Other: General clinical information; Other: scale assessment

Mood disorder without insomnia group

* do not meet the above diagnostic criteria for insomnia ② age 18 - 80 years * PSQI ≤ 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; Diagnostic Test: ambulatory electrocardiogram; Other: General clinical information; Other: scale assessment

Interventions

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.

Mood disorder with insomnia group; Mood disorder without insomnia group; Normal healthy group; Primary insomnia group

ambulatory electrocardiogram DIAGNOSTIC_TEST

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

Mood disorder with insomnia group; Mood disorder without insomnia group; Normal healthy group; Primary insomnia group

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

Mood disorder with insomnia group; Mood disorder without insomnia group; Normal healthy group; Primary insomnia group

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

Mood disorder with insomnia group; Mood disorder without insomnia group; Normal healthy group; Primary insomnia group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Qilu Hospital of Shandong University: lead

Study Sites (2)

Beijing University of Aeronautics and Astronautics

Jinan, Shandong, China

Location

Qilu Hospital of Shandong University

Jinan, Shandong, China

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders; Sleep Wake Disorders

Interventions

Electrocardiography, Ambulatory

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Nervous System Diseases; Mental Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Electrocardiography; Heart Function Tests; Diagnostic Techniques, Cardiovascular; Diagnostic Techniques and Procedures; Diagnosis; Electrodiagnosis; Monitoring, Ambulatory; Monitoring, Physiologic

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 28, 2025
• First Posted: March 27, 2026
• Study Start: October 1, 2024
• Primary Completion (Estimated): August 31, 2027
• Study Completion (Estimated): October 1, 2027
• Last Updated: March 27, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: 2024.10-2027-10

Locations

CN (2)