Not Yet RecruitingNot Applicable

Auricular Acupressure for Perimenopausal Insomnia

China160 participantsStarted 2025-06-01

Plain-language summary

This clinical trial aims to determine whether auricular Acupressure therapy can improve symptomatic insomnia in perimenopausal women. Can ear acupressure therapy significantly improve sleep quality in perimenopausal women with insomnia? What medical issues or adverse reactions might participants experience during the treatment? Researchers will compare ear acupressure therapy with traditional treatments in a control group to assess its effectiveness and safety. Participants will: Receive auricular acupressure on Monday and Thursday, applying pressure for 3 consecutive days each week. This process will continue for 4 weeks, totaling 8 sessions. Record assessment points as follows: Baseline (2 weeks before treatment to Week 0), mid-treatment (2 weeks after treatment begins), end of treatment (4 weeks after treatment begins), and follow-up (4 weeks after treatment ends) for primary and secondary outcome indicators. Eight weeks after treatment concludes, only the primary outcome indicator (Insomnia Severity Index) will be recorded. This trial seeks to evaluate the potential benefits and safety profile of auricular acupressure therapy for managing insomnia in perimenopausal women.

Who can participate

Age range

45 Years – 55 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.

Inclusion Criteria: * Age between 45 and 55 years; * Meetingperimenopause defined by the Staging of Reproductive Aging Workshop (STRAW); * Patients must satisfy at least one diagnostic criterion for insomnia in the Diagnostic and Statistical Manual of Mental Disorders (DSM-5); ④ Nighttime sleep disturbances and associated perimenopausal symptoms persisting for at least 4 weeks; ⑤ No use, or stable long-term use (\>2 months) of medications for treating insomnia; * No prior auricular acupuncture therapy, good compliance, understanding of the study protocol, and signed informed consent. Exclusion Criteria: * Does not meet inclusion criteria; * Non-natural menopausal transition due to premature ovarian failure, drug intake, or surgeries (e.g., oophorectomy); * Currently pregnant or breastfeeding; * Insomnia caused by systemic diseases (e.g., stroke, Parkinson's disease, surgery, etc.); * Presence of insomnia symptoms before the perimenopausal period; * Infection in the areas near selected acupoints; ⑦ History of alcohol or substance abuse/addiction； * Co-existing mental or psychological disorders (e.g., depression, generalized anxiety disorder, bipolar disorder, obsessive-compulsive disorder, etc.) or suicidal tendencies, in addition to insomnia; ⑨ Receipt of auricular acupuncture therapy within the past 3 months; ⑩ Participation in other clinical trials in the past 3 months; * Any known chronic pain…

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 Severe Index

Timeframe: Baseline (2 weeks before treatment), pre-treatment (0 days of treatment), mid-treatment (2 weeks after start of treatment), end of treatment (4 weeks after start of treatment), follow-up (4 weeks and 8 weeks after end of treatment）、

Trial details

NCT IDNCT06856421

SponsorThe First Affiliated Hospital of Zhejiang Chinese Medical University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-12-30

Contact for this trial

Honggen Du, Doctor

+8613958058996 19963024@zcmu.edu.cn

View on ClinicalTrials.gov More Perimenopausal Insomnia trials