Not Yet RecruitingNot Applicable

Clinical Efficacy of Thumbtack Needle for Chronic Insomnia in Perimenopausal and Menopausal Women

198 participantsStarted 2026-03-20

Plain-language summary

A multicenter, randomized, controlled, blinded clinical trial was conducted to evaluate the effects of thumbtack needle on sleep in patients with chronic insomnia during perimenopause and menopause. Randomly divided into a treatment group and a control group using the central area method, with 99 patients in each group. The treatment group received thumbtack needle treatment, while the control group received placebo thumbtack needle treatment. The treatment course for both groups was 4 weeks.

Who can participate

Age range

40 Years – 65 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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, res…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Insomnia Severity Index

Timeframe: 4 weeks

Trial details

NCT IDNCT07229976

SponsorHuazhong University of Science and Technology

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2029-12-30

View on ClinicalTrials.gov More Chronic Insomnia During Perimenopause and Menopause trials