An interventional study of Auricular Acupressure and sham Auricular Acupressure in Perimenopausal Insomnia, sponsored by The First Affiliated Hospital of Zhejiang Chinese Medical University. Not yet recruiting. Open to female participants aged 40 Years to 55 Years. Per ClinicalTrials.gov, last updated 2026-07-16.
Sponsored by The First Affiliated Hospital of Zhejiang Chinese Medical University · Not applicable, Interventional, and Treatment
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.
Exclusion Criteria:
Participants will receive auricular acupressure using adhesive auricular plasters containing Vaccaria seeds applied to the endocrine, sympathetic, Shenmen, and heart auricular acupoints. Participants will be instructed to press each seed for 30 seconds, three times daily, for 4 weeks. Adhesive plasters will be replaced twice weekly.
Other: Auricular Acupressure
Participants will receive sham auricular plasters applied to the same auricular locations without Vaccaria seeds and will not be instructed to apply pressure. Plasters will be replaced on the same schedule as the experimental group.
Other: sham Auricular Acupressure
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.
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.
Time frame: From Baseline through Week 12 (±3 days), assessed at each study visit and at early withdrawal, if applicable.
Incidence of Clinically Significant Laboratory Abnormalities
Clinically significant abnormalities identified from protocol-specified laboratory assessments, including hematology, blood biochemistry, and urinalysis, will be recorded.
Time frame: Baseline and throughout the 12-week study period, with repeat assessments performed as clinically indicated.
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.
Time frame: Week 2 (±3 days); Week 4 (±3 days); Week 8 (±3 days); Week 12 (±3 days); or at early withdrawal, if applicable.
No study locations are listed for this record.
This study is not yet recruiting, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
The First Affiliated Hospital of Zhejiang Chinese Medical University