Efficacy and Safety of Auricular Acupressure for Perimenopausal Insomnia
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Auricular Acupressure, sham Auricular Acupressure.
- Who it may be relevant to
- Registry conditions: Perimenopausal Insomnia. Basic parameters: 40 years — 55 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Efficacy and Safety of Auricular Acupressure for Perimenopausal Insomnia: A Multicenter Randomized Controlled Trial
Overview
Perimenopausal insomnia is a condition where women frequently experience poor sleep around the time of perimenopause due to perimenopausal syndrome. It mostly affects women aged 40 to 55. Compared to primary insomnia, this type has the highest incidence and comes with complex physiological and hormonal changes. Insomnia during this phase is more than just a sleep problem; it is often accompanied by symptoms like hot flashes and night sweats, which have a broad negative impact on women's physical and mental well-being. Therefore, finding effective treatment strategies is especially important. Currently, the main treatments for perimenopausal insomnia include cognitive therapy, hormone replacement therapy (HRT), and sedative-hypnotic drugs. As first-line options, cognitive therapy and HRT are widely recognized for their positive effects on improving sleep. However, long-term use of these medications can lead to dependency and increase the risk of endometrial cancer, breast cancer, stroke, and coronary heart disease. As a result, finding a safe and effective non-drug alternative is highly meaningful. At present, there is still a lack of high-quality research evidence to fully confirm the exact efficacy of auricular acupressure for perimenopausal insomnia.
Interventions
- Other Auricular Acupressure
Auricular acupressure using adhesive plasters containing Vaccaria seeds. - Other sham Auricular Acupressure
Sham auricular adhesive plasters without Vaccaria seeds or pressure stimulation.
Primary outcome measures
- Insomnia Severity Index [Time frame: Baseline, Week 2 (±3 days), Week 4 (±3 days), Week 8 (±3 days), Week 12 (±3 days); or at early withdrawal if applicable.]
Secondary outcome measures (5)
- Pittsburgh Sleep Quality Index [Time frame: Baseline; Week 2 (±3 days); Week 4 (±3 days); Week 8 (±3 days); or at early withdrawal, if applicable]
- Sleep Diary [Time frame: Daily throughout the study; summarized at Baseline, Week 2 (±3 days), Week 4 (±3 days), and Week 8 (±3 days).]
- Kupperman Index [Time frame: Baseline; Week 2 (±3 days); Week 4 (±3 days); Week 8 (±3 days); or at early withdrawal, if applicable.]
- Menopause-Specific Quality of Life Questionnaire [Time frame: Baseline; Week 2 (±3 days); Week 4 (±3 days); Week 8 (±3 days); or at early withdrawal, if applicable.]
- Heart Rate Variability [Time frame: Baseline; Week 2 (±3 days); Week 4 (±3 days); Week 8 (±3 days); or at early withdrawal, if applicable.]
Eligibility criteria
Inclusion criteria
- Female, aged 40-55 years.
- Meets the STRAW criteria for perimenopause.
- Meets DSM-5 diagnostic criteria for insomnia disorder.
- Insomnia symptoms have persisted for at least 4 weeks.
- Has not used insomnia medication or has received a stable dose for at least 2 months.
- Has not previously received auricular acupressure.
- Able to comply with study procedures.
- Provides written informed consent.
Exclusion criteria
- Pregnancy or lactation.
- Premature ovarian insufficiency.
- Surgical menopause.
- Insomnia secondary to neurological disease.
- Major psychiatric disorders.
- Alcohol or substance abuse.
- Skin infection at auricular sites.
- Participation in another clinical trial within the previous 3 months.
- Chronic pain disorders affecting sleep.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07708324 · 2026-KLS-213-02