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

S

Shandong University

Status

Invitation-only

Conditions

Sleep Disorder Insomnia Chronic

Treatments

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

Study type

Observational

Funder types

Other

Identifiers

NCT07495189
KYLL-202408-063-1

Details and patient eligibility

About

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.

Enrollment

200 estimated patients

Sex

All

Ages

18 to 80 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

200 participants in 4 patient groups

Mood disorder with insomnia group
Description:
* 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
Treatment:
Other: scale assessment
Diagnostic Test: ambulatory electrocardiogram
Other: electrocardiographic/magnetic and electroencephalographic/magnetic monitoring data
Other: General clinical information
Primary insomnia group
Description:
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
Treatment:
Other: scale assessment
Diagnostic Test: ambulatory electrocardiogram
Other: electrocardiographic/magnetic and electroencephalographic/magnetic monitoring data
Other: General clinical information
Normal healthy group
Description:
physical, mental, psychological and social relations are in perfect condition
Treatment:
Other: scale assessment
Diagnostic Test: ambulatory electrocardiogram
Other: electrocardiographic/magnetic and electroencephalographic/magnetic monitoring data
Other: General clinical information
Mood disorder without insomnia group
Description:
* 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
Treatment:
Other: scale assessment
Diagnostic Test: ambulatory electrocardiogram
Other: electrocardiographic/magnetic and electroencephalographic/magnetic monitoring data
Other: General clinical information

Trial documents
2

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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