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Acupuncture treatment for perimenopausal insomnia: a randomized controlled trial

The study on the central mechanisms and efficacy prediction of acupuncture in improving perimenopausal insomnia

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2025001008
Enrollment
Unknown
Registered
2025-05-19
Start date
2024-08-01
Completion date
Unknown
Last updated
2025-05-26

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

Conditions

perimenopausal insomnia

Interventions

acupuncture group:acupuncture treatment
sham acpuncture group:sham acpuncture treatment

Sponsors

Chengdu University of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
40 Years to 60 Years

Inclusion criteria

Inclusion criteria: (1) Female aged between 40 and 60 years right-handed; (2) Meeting the diagnostic criteria for chronic insomnia based on STRAW+10 and the International Classification of Sleep Disorders Third Edition (ICSD-3); (3) Pittsburgh Sleep Quality Index (PSQI) score > 7; (4) No use of any medications for at least two weeks prior to enrollment; (5) Willing to participate in the study and having signed the informed consent form.

Exclusion criteria

Exclusion criteria: (1) Individuals with bilateral oophorectomy organic ovarian lesions premature ovarian insufficiency polycystic ovary syndrome or hypothalamic amenorrhea; (2) Individuals with systemic diseases such as hypertension diabetes coronary heart disease or obesity (BMI = 28); (3) Individuals with severe and life-threatening primary diseases involving the cardiovascular cerebrovascular hepatic renal or hematopoietic systems; (4) Individuals with impaired consciousness who are unable to express subjective discomfort; (5) Individuals with a personal or first-degree family history of psychiatric disorders or with organic neurological diseases; (6) Individuals with insomnia caused by alcohol abuse and/or psychoactive substance abuse or dependence (including sleeping pills); (7) Individuals with severe symptoms of depression or anxiety; (8) Individuals with severe headache migraine or a history of head trauma or brain surgery; (9) Individuals who received estrogen selective serotonin reuptake inhibitors (SSRIs) or other replacement therapies within 4 weeks prior to enrollment; (10) Individuals who are pregnant planning to become pregnant or breastfeeding; (11) Individuals with contraindications to MRI such as claustrophobia or implanted metal devices (including metal dental braces).

Design outcomes

Primary

MeasureTime frame
Insomnia assessment scales;

Secondary

MeasureTime frame
Mood Assessment scales;blood test;Neuroimaging assessment indicators;Neuropsychological assessment scales;Menopause Rating Scale;Gut-related test;

Countries

China

Contacts

Public ContactLili Yang

Chengdu University of Traditional Chinese Medicine

250866823@qq.com15228824288

Outcome results

None listed

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