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Enrolling by invitation NCT07495189

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

— Observational Sleep Disorder Insomnia Chronic

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: electrocardiographic/magnetic and electroencephalographic/magnetic monitoring data, ambulatory electrocardiogram, General clinical information, scale assessment.
Who it may be relevant to
Registry conditions: Sleep Disorder Insomnia Chronic. Basic parameters: 18 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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

  • 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 outcome measures

  • High-Frequency Power of Heart Rate Variability [Time frame: Baseline (5 minutes); during each 3-minute musical stimulus; post-stimulus baseline (5 minutes)]
  • Low-Frequency Power of Heart Rate Variability [Time frame: 5-minute baseline; during each 3-minute musical stimulus; 5-minute post-stimulus baseline]
  • Magnetocardiographic Frequency-Domain Parameters [Time frame: A 5-minute baseline measurement; 5 different musical stimuli, each lasting 3 minutes; a 5-minute baseline measurement]
  • 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 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 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 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]
Secondary outcome measures (10)
  • 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]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Other

Study locations

China · 2 centers
  • Beijing University of Aeronautics and Astronautics — Jinan
  • Qilu Hospital of Shandong University — Jinan

Identifiers

NCT: NCT07495189 · KYLL-202408-063-1

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗