Efficacy and Safety of Auricular Acupressure for Perimenopausal Insomnia

Efficacy and Safety of Auricular Acupressure for Perimenopausal Insomnia: A Multicenter Randomized Controlled Trial

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Perimenopausal Insomnia
• Intervention / Treatment: Other: Auricular Acupressure; Other: sham Auricular Acupressure

• Study Type: Interventional
• Enrollment (Estimated): 98
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Treatment Group; Participants will receive auricular acupressure using adhesive auricular plasters containing Vaccaria seeds applied to the endocrine, sympathetic, Shenmen, and heart auricular acupoints. Participants will be instructed to press each seed for 30 seconds, three times daily, for 4 weeks. Adhesive plasters will be replaced twice weekly.	Other: Auricular Acupressure; Auricular acupressure using adhesive plasters containing Vaccaria seeds.
Sham Comparator: Control Group; Participants will receive sham auricular plasters applied to the same auricular locations without Vaccaria seeds and will not be instructed to apply pressure. Plasters will be replaced on the same schedule as the experimental group.	Other: sham Auricular Acupressure; Sham auricular adhesive plasters without Vaccaria seeds or pressure stimulation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Insomnia Severity Index	The Insomnia Severity Index (ISI) is a validated 7-item questionnaire with total scores ranging from 0 to 28. Higher scores indicate more severe insomnia.	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

Outcome Measure	Measure Description	Time Frame
Pittsburgh Sleep Quality Index	The Pittsburgh Sleep Quality Index (PSQI) is a validated self-reported questionnaire assessing sleep quality over the previous month. Total scores range from 0 to 21, with higher scores indicating poorer sleep quality.	Baseline; Week 2 (±3 days); Week 4 (±3 days); Week 8 (±3 days); or at early withdrawal, if applicable
Sleep Diary	Participants will complete a standardized daily sleep diary to record bedtime, sleep onset latency, number of nocturnal awakenings, wake after sleep onset, wake-up time, total sleep time, and subjective sleep quality. Diary data will be summarized over the predefined assessment period for analysis.	Daily throughout the study; summarized at Baseline, Week 2 (±3 days), Week 4 (±3 days), and Week 8 (±3 days).
Kupperman Index	The Kupperman Index is a validated questionnaire used to assess the severity of menopausal symptoms, including hot flashes, sweating, insomnia, mood changes, fatigue, and other climacteric symptoms. Higher total scores indicate greater symptom severity.	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	The Menopause-Specific Quality of Life (MENQOL) questionnaire is a validated self-reported instrument that assesses menopause-related quality of life across vasomotor, psychosocial, physical, and sexual domains. Scores will be calculated according to the validated scoring manual used in this study. Higher scores indicate poorer menopause-specific quality of life.	Baseline; Week 2 (±3 days); Week 4 (±3 days); Week 8 (±3 days); or at early withdrawal, if applicable.
Heart Rate Variability	Heart rate variability (HRV) will be assessed using standardized electrocardiographic recordings as an objective measure of autonomic nervous system function. Time-domain and frequency-domain HRV parameters will be analyzed according to the predefined study protocol.	Baseline; Week 2 (±3 days); Week 4 (±3 days); Week 8 (±3 days); or at early withdrawal, if applicable.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Treatment-Emergent Adverse Events (TEAEs)	Treatment-emergent adverse events (AEs) and serious adverse events (SAEs) will be recorded throughout the study. Events will be classified according to severity, seriousness, and their relationship to the study intervention. Local adverse reactions related to auricular acupressure (including erythema, swelling, pruritus, skin irritation, infection, and allergic reactions) will also be recorded.	From Baseline through Week 12 (±3 days), assessed at each study visit and at early withdrawal, if applicable.
Incidence of Clinically Significant Laboratory Abnormalities	Clinically significant abnormalities identified from protocol-specified laboratory assessments, including hematology, blood biochemistry, and urinalysis, will be recorded.	Baseline and throughout the 12-week study period, with repeat assessments performed as clinically indicated.
Treatment Compliance	Treatment compliance will be evaluated using a predefined composite compliance assessment. Participants will be considered compliant if they complete scheduled auricular plaster replacement and, for the experimental group, perform self-acupressure according to the prescribed frequency and duration. Overall compliance will be reported as the proportion of participants meeting all predefined compliance criteria.	Week 2 (±3 days); Week 4 (±3 days); Week 8 (±3 days); Week 12 (±3 days); or at early withdrawal, if applicable.

Collaborators and Investigators

• Sponsor: The First Affiliated Hospital of Zhejiang Chinese Medical University

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): May 31, 2027
• Study Completion (Estimated): August 31, 2027

Study Registration Dates

• First Submitted: June 24, 2026
• First Submitted That Met QC Criteria: July 10, 2026
• First Posted (Actual): July 16, 2026

Study Record Updates

• Last Update Posted (Actual): July 16, 2026
• Last Update Submitted That Met QC Criteria: July 10, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: 2026-KLS-213-02

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No