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Heterogeneous Clinical Responses and Underlying Mechanisms of Acupuncture in a High-Risk Depressive Subtype of Middle-Aged Women with Insomnia

Heterogeneous Clinical Responses and Underlying Mechanisms of Acupuncture in a High-Risk Depressive Subtype of Middle-Aged Women with Insomnia

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2026000141
Enrollment
Unknown
Registered
2026-01-24
Start date
2026-03-01
Completion date
Unknown
Last updated
2026-02-02

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

Conditions

Insomnia

Interventions

Highly Distressed real acupunture group:Real acupunture treatment
Highly Distressed sham acupunture group:Sham acupunture treatment
Moderately Distressed, Reward Sensitive real acupunture group:Real acupunture treatment
Moderately Distressed, Reward Sensitive sham acupunture group:Sham acupunture treatment
Moderately Distressed, Reward Insensitive real acupunture group:Real acupunture treatment
Moderately Distressed, Reward Insensitive sham acupunture group:Sham acupunture treatment

Sponsors

Hospital of Chengdu University of TCM
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
40 Years to 65 Years

Inclusion criteria

Inclusion criteria: (1) Female right-handed; (2) Age 40 years = age = 65 years education duration = 6 years; (3) Meet the diagnostic criteria for chronic insomnia as defined by ICSD-3; (4) Pittsburgh Sleep Quality Index (PSQI) score > 7; (5) Within the 2 weeks prior to enrollment no anesthetic drugs or other psychotropic drugs were taken by the patient; (6) Willing to participate in the study and having signed the informed consent form. Note: Only patients meeting all the above criteria can be included in this study.

Exclusion criteria

Exclusion criteria: (1) Other types of sleep disorders including sleep apnea syndrome sleep-related movement disorders central sleep disorders hypersomnia and sleep-wake rhythm disorders; (2) Bilateral oophorectomy organic lesions of the ovary premature ovarian failure polycystic ovary syndrome and hypothalamic amenorrhea; (3) Those with systemic diseases such as hypertension diabetes coronary heart disease obesity etc. and complicated with severe heart liver kidney brain and hematopoietic system diseases; (4) History of mental disorders such as depression bipolar disorder anxiety disorder schizophrenia personality changes etc. and history of alcohol drug or coffee dependence; (5) Patient who received estrogen selective serotonin reuptake inhibitors (SSRIs) or other replacement therapies within 4 weeks prior to enrollment; (6) Pregnant women lactating women and those with a desire to conceive in the next three months; (7) MRI scan contraindications such as the implantation of electronic and metal devices. Note: Any patient meeting any of the above criteria will be excluded.

Design outcomes

Primary

MeasureTime frame
Insomnia Assessment;

Secondary

MeasureTime frame
Demographic Data;Neuropsychological cognitive assessment;Mood Assessment;Multimodal neuroimaging assessment;Gut-related test;Blood test;

Countries

China

Contacts

Public ContactFen Feng

Hospital of Chengdu University of TCM

fengf01@126.com13547959969

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: Feb 7, 2026