Sleep Disorder Insomnia ChronicmechanismsNCT07495189
A Study of the Mechanisms by Which Mood and Sleep Disorders Interact
An observational study of Sleep Disorder Insomnia Chronic, run by Qilu Hospital of Shandong University at 2 sites in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Sleep Disorder Insomnia Chronic
- What is being tested?
- electrocardiographic/magnetic and electroencephalographic/magnetic monitoring data, ambulatory electrocardiogram and General clinical information
- How many people
- 200 participants
- Where
- 2 sitesChina
- Study dates
- 1 Oct 2024to 1 Oct 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites
Beijing University of Aeronautics and Astronautics
Jinan, Shandong
Qilu Hospital of Shandong University
Jinan, Shandong
About this study
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
- Being tested
- electrocardiographic/magnetic and electroencephalographic/magnetic monitoring data, ambulatory electrocardiogram, General clinical information, scale assessment
- Keywords
- sleep disorder, Heart-brain axis, magnetoencephalography, magnetocardiography
- Medical subject headings
- Sleep Initiation and Maintenance Disorders, Sleep Wake Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
electrocardiographic/magnetic and electroencephalographic/magnetic monitoring dataOther
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.
ambulatory electrocardiogramDiagnostic test
Subjects wore a dynamic ECG for 24 hours before the start of the tria
General clinical informationOther
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
scale assessmentOther
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: 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 Receives: 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 Receives: Other: electrocardiographic/magnetic and electroencephalographic/magnetic monitoring data; Diagnostic Test: ambulatory electrocardiogram; Other: General clinical information; Other: scale assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 5-minute baseline; during each 3-minute musical stimulus; 5-minute post-stimulus baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2026
- Study start1 Oct 2024
- Primary completion31 Aug 2027 (estimated)
- Study completion1 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep Disorder Insomnia ChronicStudies of the same condition, open and under way.
- More trials run by Qilu Hospital of Shandong UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Qilu Hospital of Shandong University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07495189
- Sponsor's protocol ID
- KYLL-202408-063-1
- Acronym
- mechanisms
- Status last verified
- Feb 2026
- First submitted
- 28 Jul 2025
- Last updated
- 27 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 2024-10Network sharing
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of the Mechanisms by Which Mood and Sleep Disorders Interact
- ClinicalTrials.gov ID
- NCT07495189
- Acronym / sponsor ID
- mechanisms / KYLL-202408-063-1
- Conditions
- Sleep Disorder Insomnia Chronic
- Keywords
- sleep disorder, Heart-brain axis, magnetoencephalography, magnetocardiography
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Qilu Hospital of Shandong UniversityUniversity, hospital or other
- Study start
- 1 Oct 2024 (actual)
- Primary completion
- 31 Aug 2027 (estimated)
- Study completion
- 1 Oct 2027 (estimated)
- First posted
- 27 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Mood disorder with insomnia group | – | Other: electrocardiographic/magnetic and electroencephalographic/magnetic monitoring data, Diagnostic Test: ambulatory electrocardiogram, Other: General clinical information, Other: scale assessment* 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 |
| Primary insomnia group | – | Other: electrocardiographic/magnetic and electroencephalographic/magnetic monitoring data, Diagnostic Test: ambulatory electrocardiogram, Other: General clinical information, Other: scale assessment①meet 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 |
| Normal healthy group | – | Other: electrocardiographic/magnetic and electroencephalographic/magnetic monitoring data, Diagnostic Test: ambulatory electrocardiogram, Other: General clinical information, Other: scale assessmentphysical, mental, psychological and social relations are in perfect condition |
| Mood disorder without insomnia group | – | Other: electrocardiographic/magnetic and electroencephalographic/magnetic monitoring data, Diagnostic Test: ambulatory electrocardiogram, Other: General clinical information, Other: scale assessment* 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 |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| electrocardiographic/magnetic and electroencephalographic/magnetic monitoring dataFirst, 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. | Other | Mood disorder with insomnia group, Mood disorder without insomnia group, Normal healthy group, Primary insomnia group |
| ambulatory electrocardiogramSubjects wore a dynamic ECG for 24 hours before the start of the tria | Diagnostic test | Mood disorder with insomnia group, Mood disorder without insomnia group, Normal healthy group, Primary insomnia group |
| General clinical informationGeneral 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 | Mood disorder with insomnia group, Mood disorder without insomnia group, Normal healthy group, Primary insomnia group |
| scale assessmentMeasure 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 | Other | Mood disorder with insomnia group, Mood disorder without insomnia group, Normal healthy group, Primary insomnia group |
Primary outcome
High-Frequency Power of Heart Rate Variability
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).
Low-Frequency Power of Heart Rate Variability
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).
Magnetocardiographic Frequency-Domain Parameters
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.
Electroencephalographic Event-Related Potential Components
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.
Electroencephalographic Oscillatory Power
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.
Magnetoencephalographic Event-Related Field Components
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.
Magnetoencephalographic Oscillatory Power
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.
10 secondary outcomes
Demographic Characteristics
Time frame: Before the experiment begins
Pittsburgh Sleep Quality Index (PSQI)
Time frame: Before the experiment begins
Hamilton Anxiety Rating Scale (HAMA)
Time frame: Before the experiment begins
Hamilton Depression Rating Scale (HAMD)
Time frame: Before the experiment begins
Montreal Cognitive Assessment (MoCA)
Time frame: Before the experiment begins
Mini-Mental State Examination (MMSE)
Time frame: Before the experiment begins
Magnetocardiographic Signal Amplitude
Time frame: 5-minute baseline; during each 3-minute musical stimulus; 5-minute post-stimulus baseline
Standard Deviation of Normal-to-Normal Intervals
Time frame: 5-minute baseline; during each 3-minute musical stimulus; 5-minute post-stimulus baseline
Magnetocardiographic Signal Duration
Time frame: 5-minute baseline; during each 3-minute musical stimulus; 5-minute post-stimulus baseline
Magnetocardiographic Waveform Field Strength
Time frame: 5-minute baseline; during each 3-minute musical stimulus; 5-minute post-stimulus baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2026.
- Individual participant dataSharing planned: Yes. 2024-10Network sharing
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sleep Disorder Insomnia Chronic, run by Qilu Hospital of Shandong University at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 27 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
High-Frequency Power of Heart Rate Variability (time frame: Baseline (5 minutes); during each 3-minute musical stimulus; post-stimulus baseline (5 minutes)). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2026.