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NCT Number: NCT07708324

Efficacy and Safety of Auricular Acupressure for Perimenopausal Insomnia

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.

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Key information

Conditions

Perimenopausal Insomnia

Age range

40 year–55 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

auricular acupressure

Other

Auricular acupressure using adhesive plasters containing Vaccaria seeds.

sham auricular acupressure

Other

Sham auricular adhesive plasters without Vaccaria seeds or pressure stimulation.

Primary outcomes

  1. 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.

    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.

Secondary outcomes

  1. 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

    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.

  2. Sleep Diary

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

    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.

  3. Kupperman Index

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

    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.

  4. 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.

    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.

  5. Heart Rate Variability

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

    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.

Other outcomes

  1. Incidence of Treatment-Emergent Adverse Events (TEAEs)

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

    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.

  2. Incidence of Clinically Significant Laboratory Abnormalities

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

    Clinically significant abnormalities identified from protocol-specified laboratory assessments, including hematology, blood biochemistry, and urinalysis, will be recorded.

  3. Treatment Compliance

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

    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.

Sponsors and collaborators

Lead sponsor

The First Affiliated Hospital of Zhejiang Chinese Medical University

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jul 16, 2026
Registry last updated
Jul 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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