Efficacy and Safety of Auricular Acupressure for Perimenopausal Insomnia: A Multicenter Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 98
- 主要终点
- Insomnia Severity Index
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 55 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Insomnia Severity Index
时间窗: 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.
次要结局
- 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.)
研究者
Chen Shao
Attending Physician
The First Affiliated Hospital of Zhejiang Chinese Medical University