Efficacy and Safety of Auricular Acupressure for Perimenopausal Insomnia

NCT07708324 | Not Yet Recruiting DMC

• 1 other identifier: 2026-KLS-213-02
• Study Type: interventional
• Target: 98
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Perimenopausal Insomnia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Pittsburgh Sleep Quality Index

  Baseline; Week 2 (±3 days); Week 4 (±3 days); Week 8 (±3 days); or at early withdrawal, if applicable

• Sleep Diary

  Daily throughout the study; summarized at Baseline, Week 2 (±3 days), Week 4 (±3 days), and Week 8 (±3 days).

• Kupperman Index

  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

  Baseline; Week 2 (±3 days); Week 4 (±3 days); Week 8 (±3 days); or at early withdrawal, if applicable.

• Heart Rate Variability

  Baseline; Week 2 (±3 days); Week 4 (±3 days); Week 8 (±3 days); or at early withdrawal, if applicable.

Other Outcomes (3)

• Incidence of Treatment-Emergent Adverse Events (TEAEs)

  From Baseline through Week 12 (±3 days), assessed at each study visit and at early withdrawal, if applicable.

• Incidence of Clinically Significant Laboratory Abnormalities

  Baseline and throughout the 12-week study period, with repeat assessments performed as clinically indicated.

• Treatment Compliance

  Week 2 (±3 days); Week 4 (±3 days); Week 8 (±3 days); Week 12 (±3 days); or at early withdrawal, if applicable.

Study Arms (2)

Treatment Group

OTHER

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

Control Group

SHAM COMPARATOR

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

Interventions

Auricular Acupressure OTHER

Auricular acupressure using adhesive plasters containing Vaccaria seeds.

Treatment Group

sham Auricular Acupressure OTHER

Sham auricular adhesive plasters without Vaccaria seeds or pressure stimulation.

Control Group

Eligibility Criteria

• Age: 40 Years - 55 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending Physician

Study Record Dates

• First Submitted: June 24, 2026
• First Posted: July 16, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): May 31, 2027
• Study Completion (Estimated): August 31, 2027
• Last Updated: July 16, 2026

Record last verified: 2026-06