Thumbtack needle for chronic insomnia in perimenopausal and menopausal women
Official title: Clinical Efficacy of Thumbtack Needle for Chronic Insomnia in Perimenopausal and Menopausal Women: A Multicenter Randomized Controlled Trial
Run by Huazhong University of Science and Technology · NCT07229976 · Data updated 2026-11-12
This trial tests whether thumbtack needle treatment helps sleep in women aged 40–65 who are near or in menopause and have chronic insomnia.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 40 Years to 65 Years |
| Sex | Women only |
| Enrollment | 198 (estimated) |
| Sponsor | Huazhong University of Science and Technology Academic / other |
| Locations | 8 sites (Chibi, Hubei and 7 other locations) |
| Status | Recruiting |
| Started | March 20, 2026 |
| Main results expected | December 30, 2029 |
| Study ends | December 30, 2029 |
| Registry record updated | October 27, 2026 |
| Trial ID | NCT07229976 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Women aged 40–65 who meet perimenopause or menopause criteria and have chronic insomnia with an ISI score of 12 or higher.
✕Probably not a fit
Individuals who do not respond to needle-based therapies or who fail to meet sensitivity thresholds may not experience sleep improvement.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This multicenter, randomized, blinded trial compares thumbtack needle therapy to a placebo version in 198 women with chronic insomnia during perimenopause or menopause. Participants are randomly assigned to the active or placebo treatment for four weeks, with sleep outcomes assessed to determine if the thumbtack needle provides additional benefit over placebo. The study uses standard criteria for menopause status and insomnia and is conducted at three sites in Hubei, China. The lead sponsor is Huazhong University of Science and Technology.
Why it matters
Potential benefit: If successful, patients may experience improved sleep quality and shorter time to fall asleep thanks to the thumbtack needle approach.
How similar studies have gone: Prior studies in needle-based approaches for sleep have shown mixed results; this trial aims to provide higher-quality evidence with a blinded, randomized design.
Who can join: the full rules
Show full inclusion / exclusion criteria
Diagnostic criteria for perimenopause and menopause: * Perimenopausal period: a period of time from one year before the last menstrual period to the first year after the last menstrual period. Having at least one menstrual period in the past 12 months, or being under 55 years old, undergoing hysterectomy or endometrial ablation, but not bilateral oophorectomy; * Menopause: No menstruation in the past 12 months, or bilateral oophorectomy, or age 55 years or older, who has undergone hysterectomy or endometrial ablation; Diagnostic criteria for chronic insomnia: ●The diagnostic criteria for insomnia in the third edition of the International Classification of Sleep Disorders (ICSD-3) of the American Academy of Sleep Medicine (all criteria A to F must be met). Inclusion Criteria: * Women aged 40 to 65 who meet the diagnostic criteria for perimenopause and menopause mentioned above; * Evaluate ISI score ≥ 12 points through a scale; * Meets the diagnostic criteria for chronic insomnia mentioned above, i.e. ICSD-3 meets both criteria A to F; * Voluntarily participate in this study and sign an informed consent form. Exclusion Criteria: Patients who meet any of the following conditions will not be included; * Use hormone replacement therapy, anti anxiety drugs, antidepressants, or medications to improve insomnia within one month; * Individuals with a history of diagnosed sleep disorders before menopause; * Combined with other sleep disorders such as obstructive sleep apnea, restless leg syndrome, etc; * Patients with malignant tumors, especially estrogen dependent tumors (such as breast cancer and endometrial cancer); * Recent (within 6 months) history of myocardial infarction, stroke, venous thrombosis, etc; * Patients with mental illnesses, such as severe depression and uncontrolled schizophrenia; * Serious disorder of endocrine system, such as uncontrolled hyperthyroidism, diabetes ketoacidosis, etc * Patients with coagulation disorders, such as hemophilia, long-term use of anticoagulants (warfarin, aspirin, etc.), etc; * Long term alcohol consumption history (more than 5 years, daily alcohol consumption exceeding 12 taels, not quitting drinking); * Engaged in night shift work (\>3 times a week); * Individuals with infections, ulcers, burns, rashes, or scars at acupoints; * Previously received acupuncture treatment; * I do not agree to sign the informed consent form for this study.
Where it's running
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Chibi Maternal and Child Health Hospital
Chibi, Hubei, China Recruiting -
Jingzhou Hospital of Traditional Chinese Medicine
Jingzhou, Hubei, China Recruiting -
Qianjiang Central Hospital
Qianjiang, Hubei, China Recruiting -
Wuhan Children's Hospital
Wuhan, Hubei, China Recruiting -
Renmin Hospital of Wuhan University
Wuhan, Hubei, China Recruiting -
Rehabilitation Center, Wuhan Puren Hospital
Wuhan, Hubei, China Recruiting
Show 2 more locations
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Xiaogan Maternal and Child Health Care Hospital
Wuhan, Hubei, China Recruiting -
Aksu Prefecture Maternal and Child Health Hospital
Aksu, Xuar, China Recruiting
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.