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Study on clinical effect mechanism of electroacupuncture in the treatment of insomnia disorder based on metabonomics

Study on clinical effect mechanism of electroacupuncture in the treatment of insomnia disorder based on metabonomics

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400085660
Enrollment
Unknown
Registered
2024-06-14
Start date
2024-06-17
Completion date
Unknown
Last updated
2024-07-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

insomnia disorder

Interventions

insomnia disorder group:electroacupuncture

Sponsors

Affiliated Hospital of Nanjing University of Chinese Medicine (Jiangsu Provincial Hospital of Chinese Medicine)
Lead Sponsor

Eligibility

Sex/Gender
All
Age
24 Years to 60 Years

Inclusion criteria

Inclusion criteria: 1. Insomnia disorder is included in the standard. (1) the age is 18-60 years old; (2) Conforming to ICSD-3 diagnostic criteria; (3)5 points < psqi < 17 points; (4) Not receiving psychotropic drugs; (5) There is no communication and cognitive obstacle, and basic operation can be performed on the smart phone; (6) Sign the informed consent form. 2. Inclusion criteria for healthy people (1) After consultation and health examination, blood routine, liver function, kidney function, electrocardiogram, blood sugar and blood lipid are normal; Good health, no patients with organic or functional diseases or mental illness in the past; (2) aged between 18 and 60; (3) Not participating in other clinical studies recently; (4) Participate in this experiment voluntarily, and agree and sign the informed consent form of this experiment.

Exclusion criteria

Exclusion criteria: 1. Insomnia disorder exclusion criteria (1) serious diseases such as neuroendocrine, cardiovascular and cerebrovascular diseases, hematopoietic system and tumors; (2) Sleep disorder caused by depression, anxiety, schizophrenia or other serious mental illness, HAMA score > 14 and/or HAMD score > 17; (3) Other sleep disorders, or any other sleep disorders found on sleep monitoring (PPSG) at baseline, such as obstructive sleep apnea, rapid eye movement (REM) sleep disorder or restless legs syndrome; (4) those who are not suitable for acupuncture treatment during pregnancy or lactation; (5) Those who have received acupuncture treatment for insomnia in the past month; (6) Alcohol and/or other drug abusers or addicts. 2. Exclusion criteria for healthy subjects (1) pregnant and lactating women; (2) Alcoholics and smokers.1. Insomnia exclusion criteria (1) serious diseases such as neuroendocrine, cardiovascular and cerebrovascular diseases, hematopoietic system and tumors; (2) Sleep disorder caused by depression, anxiety, schizophrenia or other serious mental illness, HAMA score > 14 and/or HAMD score > 17; (3) Other sleep disorders, or any other sleep disorders found on sleep monitoring (PPSG) at baseline, such as obstructive sleep apnea, rapid eye movement (REM) sleep disorder or restless legs syndrome; (4) those who are not suitable for acupuncture treatment during pregnancy or lactation; (5) Those who have received acupuncture treatment for insomnia in the past month; (6) Alcohol and/or other drug abusers or addicts. 2. Exclusion criteria for healthy subjects (1) pregnant and lactating women; (2) Alcoholics and smokers.

Design outcomes

Primary

MeasureTime frame
Pittsburgh Sleep Quality Index;Serum metabonomics;

Secondary

MeasureTime frame
Electrocardiogram monitoring;Insomnia Severity Index;Hyperarousal Scale;Fatigue Severity Scale;Hamilton Anxiety Scale;Hamilton Depression Scale;

Countries

China

Contacts

Public Contactliuchengyong

Affiliated Hospital of Nanjing University of Chinese Medicine (Jiangsu Provincial Hospital of Chinese Medicine)

lcy8601@163.com+86 138 5141 5038

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026