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.
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.
Pregnancy or lactation.
Premature ovarian insufficiency.
Surgical menopause.
Insomnia secondary to neurological disease.
Parallel
Auricular Acupressure
Other interventionAuricular acupressure using adhesive plasters containing Vaccaria seeds.
sham Auricular Acupressure
Other interventionSham 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.
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.
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.
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.
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.
Incidence of Treatment-Emergent Adverse Events (TEAEs)
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.
Incidence of Clinically Significant Laboratory Abnormalities
Clinically significant abnormalities identified from protocol-specified laboratory assessments, including hematology, blood biochemistry, and urinalysis, will be recorded.
Treatment Compliance
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.
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options:
