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Evaluation of Clinical Response and Mechanism Study of Acupuncture Treatment in Middle-Aged Female Insomnia Patients with Different Cognitive Levels

Evaluation of Clinical Response and Mechanism Study of Acupuncture Treatment in Middle-Aged Female Insomnia Patients with Different Cognitive Levels

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2025002400
Enrollment
Unknown
Registered
2025-12-06
Start date
2025-12-25
Completion date
Unknown
Last updated
2026-01-12

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

Conditions

Insomnia

Interventions

Cognitively preserved and real acupunture group:Real acupunture treatment
Cognitively preserved and sham acupunture group:Sham acupunture treatment
Mildly cognitively impaired and real acupunture group:Real acupunture treatment
Mildly cognitively impaired and sham acupunture group:Sham acupunture treatment
Cognitively impaired and real acupunture group:Real acupunture treatment
Healthy control group:No intervention
Cognitively impaired and sham acupunture group:Sham acupunture treatment

Sponsors

Chengdu University of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
40 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Inclusion criteria for patients with insomnia: (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. 2. Inclusion criteria for healthy subjects: (1) Female right-handed; (2) Age 40 years = age = 65 years education duration = 6 years; (3) PSQI score = 5; (4) ISI score < 8; (5) No medication taken within 2 weeks prior to enrollment; (6) Willing to participate in the study and having signed the informed consent form. Note: Only participant meeting all the above criteria can be included in this study.

Exclusion criteria

Exclusion criteria: 1. Exclusion criteria for patients with insomnia: (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. 2. Exclusion criteria for healthy subjects: (1) Bilateral oophorectomy organic lesions of the ovary premature ovarian failure polycystic ovary syndrome and hypothalamic amenorrhea; (2) 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; (3) History of mental disorders such as depression bipolar disorder anxiety disorder schizophrenia personality changes etc. and history of alcohol drug or coffee dependence; (4) Pregnant women lactating women and those with a desire to conceive in the next three months; (5) MRI scan contraindications such as the implantation of electronic and metal devices. Note: Any participant meeting any of the above criteria will be excluded.

Design outcomes

Primary

MeasureTime frame
Insomnia Assessment;

Secondary

MeasureTime frame
Demographic Data;Neurocognitive assessment;Mood Assessment;Gut-related test;Blood test;Neuroimaging Assessment Indicators;

Countries

China

Contacts

Public ContactSiyi Yu

Chengdu University of Traditional Chinese Medicine

cdutcmysy@gmail.com13668171182

Outcome results

None listed

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