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

Browse trials for

• Sleep Initiation and Maintenance Disorders 1,856
• Sleep Wake Disorders 788

Keywords

• sleep disorder
• Heart-brain axis
• magnetoencephalography
• magnetocardiography

Sleep Initiation and Maintenance Disorders

1,856 studies on the registry are indexed under Sleep Initiation and Maintenance Disorders; 594 are open to participants now.

This study's planned enrollment of 200 is above the median of 128 across 191 observational studies indexed under Sleep Initiation and Maintenance Disorders.

Lead sponsor

Qilu Hospital of Shandong University is the lead sponsor of 299 studies on the registry; 181 are open to participants now.

Study population

Eligibility criteria

Groups and cohorts

• 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

• 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

Primary outcomes

1. 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).

   Time frame: Baseline (5 minutes); during each 3-minute musical stimulus; post-stimulus baseline (5 minutes)

2. 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).

   Time frame: 5-minute baseline; during each 3-minute musical stimulus; 5-minute post-stimulus baseline

3. 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.

   Time frame: A 5-minute baseline measurement; 5 different musical stimuli, each lasting 3 minutes; a 5-minute baseline measurement

4. 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.

   Time frame: A 5-minute baseline measurement; responses during five different musical stimuli, each lasting 3 minutes; a second 5-minute baseline measurement

5. 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.

   Time frame: A 5-minute baseline measurement; responses during five different musical stimuli, each lasting 3 minutes; a second 5-minute baseline measurement

6. 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.

   Time frame: A 5-minute baseline measurement; responses during five different musical stimuli, each lasting 3 minutes; a second 5-minute baseline measurement

7. 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.

   Time frame: A 5-minute baseline measurement; responses during five different musical stimuli, each lasting 3 minutes; a second 5-minute baseline measurement

Secondary outcomes

1. 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.

   Time frame: Before the experiment begins

2. 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.

   Time frame: Before the experiment begins

3. 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.

   Time frame: Before the experiment begins

4. 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.

   Time frame: Before the experiment begins

5. 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.

   Time frame: Before the experiment begins

6. 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.

   Time frame: Before the experiment begins

7. Magnetocardiographic Signal Amplitude

   Peak magnetic signal amplitude of cardiac activity measured using magnetocardiography during baseline and musical stimulation periods, reported in Tesla (T).

   Time frame: 5-minute baseline; during each 3-minute musical stimulus; 5-minute post-stimulus baseline

8. 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).

   Time frame: 5-minute baseline; during each 3-minute musical stimulus; 5-minute post-stimulus baseline

9. Magnetocardiographic Signal Duration

   Duration of magnetocardiographic cardiac waveform measured during baseline and musical stimulation periods, reported in milliseconds (ms).

   Time frame: 5-minute baseline; during each 3-minute musical stimulus; 5-minute post-stimulus baseline

10. Magnetocardiographic Waveform Field Strength

    Magnetic field strength of specific cardiac waveform components measured during baseline and musical stimulation periods, reported in Tesla (T).

    Time frame: 5-minute baseline; during each 3-minute musical stimulus; 5-minute post-stimulus baseline

Study documents

• Study protocol · Oct 11, 2024
• Informed consent form · Oct 11, 2024

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: Yes — 2024-10Network sharing

Supporting information: Study protocol, Sap, Icf, Csr, Analytic code