Clinical Efficacy of Thumbtack Needle for Chronic Insomnia in Perimenopausal and Menopausal Women (NCT07229976) | Clinical Trial Compass
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 range40 Years – 65 Years
SexFEMALE
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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…
What they're measuring
1
Insomnia Severity Index
Timeframe: 4 weeks
Trial details
NCT IDNCT07229976
SponsorHuazhong University of Science and Technology