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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
98
Auricular acupressure using adhesive plasters containing Vaccaria seeds.
Sham auricular adhesive plasters without Vaccaria seeds or pressure stimulation.
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.
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.
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline; Week 2 (±3 days); Week 4 (±3 days); Week 8 (±3 days); or at early withdrawal, if applicable.
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