Efficacy and Safety of Auricular Acupressure for Perimenopausal Insomnia

Официальное название

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

Обзор

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.

Вмешательства

• Другое Auricular Acupressure
  Auricular acupressure using adhesive plasters containing Vaccaria seeds.
• Другое sham Auricular Acupressure
  Sham auricular adhesive plasters without Vaccaria seeds or pressure stimulation.

Первичные конечные точки

• Insomnia Severity Index [Срок оценки: Baseline, Week 2 (±3 days), Week 4 (±3 days), Week 8 (±3 days), Week 12 (±3 days); or at early withdrawal if applicable.]

Вторичные конечные точки (5)

• Pittsburgh Sleep Quality Index [Срок оценки: Baseline; Week 2 (±3 days); Week 4 (±3 days); Week 8 (±3 days); or at early withdrawal, if applicable]
• Sleep Diary [Срок оценки: Daily throughout the study; summarized at Baseline, Week 2 (±3 days), Week 4 (±3 days), and Week 8 (±3 days).]
• Kupperman Index [Срок оценки: 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 [Срок оценки: Baseline; Week 2 (±3 days); Week 4 (±3 days); Week 8 (±3 days); or at early withdrawal, if applicable.]
• Heart Rate Variability [Срок оценки: Baseline; Week 2 (±3 days); Week 4 (±3 days); Week 8 (±3 days); or at early withdrawal, if applicable.]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Тройное слепое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07708324 · 2026-KLS-213-02

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗