[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100647324":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":24,"centralContacts":24,"locations":24,"responsibleParty":29,"collaborators":24,"id":33,"slug":34,"hasResults":35,"nctId":36,"briefTitle":37,"officialTitle":38,"acronym":24,"eligibilityCriteria":39,"healthyVolunteers":35,"sex":40,"minAge":41,"maxAge":42,"enrollmentInfo":43,"targetDuration":24,"studyType":46,"phases":47,"briefSummary":49,"conditions":50,"keywords":24,"overallStatus":52,"whyStopped":24,"lastUpdateSubmitDate":53,"lastUpdatePostDateStruct":54,"startDateStruct":57,"completionDateStruct":59,"leadSponsor":61,"locationsCount":24},{"fullName":5,"class":6},"The First Affiliated Hospital of Zhejiang Chinese Medical University","OTHER",[8,13],{"label":9,"type":6,"description":10,"interventionNames":11},"Treatment Group","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.",[12],"Other: Auricular Acupressure",{"label":14,"type":15,"description":16,"interventionNames":17},"Control Group","SHAM_COMPARATOR","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.",[18],"Other: sham Auricular Acupressure",[20,25],{"type":6,"name":21,"description":22,"armGroupLabels":23,"otherNames":24},"Auricular Acupressure","Auricular acupressure using adhesive plasters containing Vaccaria seeds.",[9],null,{"type":6,"name":26,"description":27,"armGroupLabels":28,"otherNames":24},"sham Auricular Acupressure","Sham auricular adhesive plasters without Vaccaria seeds or pressure stimulation.",[14],{"type":30,"investigatorFullName":31,"investigatorTitle":32,"investigatorAffiliation":5,"oldNameTitle":24,"oldOrganization":24},"PRINCIPAL_INVESTIGATOR","Chen Shao","Attending Physician","100647324","efficacy-and-safety-of-auricular-acupressure-for-perimenopausal-insomnia-100647324",false,"NCT07708324","Efficacy and Safety of Auricular Acupressure for Perimenopausal Insomnia","Efficacy and Safety of Auricular Acupressure for Perimenopausal Insomnia: A Multicenter Randomized Controlled Trial","Inclusion Criteria:\n\n* Female, aged 40-55 years.\n* Meets the STRAW criteria for perimenopause.\n* Meets DSM-5 diagnostic criteria for insomnia disorder.\n* Insomnia symptoms have persisted for at least 4 weeks.\n* Has not used insomnia medication or has received a stable dose for at least 2 months.\n* Has not previously received auricular acupressure.\n* Able to comply with study procedures.\n* Provides written informed consent.\n\nExclusion Criteria:\n\n* Pregnancy or lactation.\n* Premature ovarian insufficiency.\n* Surgical menopause.\n* Insomnia secondary to neurological disease.\n* Major psychiatric disorders.\n* Alcohol or substance abuse.\n* Skin infection at auricular sites.\n* Participation in another clinical trial within the previous 3 months.\n* Chronic pain disorders affecting sleep.","FEMALE","40 Years","55 Years",{"count":44,"type":45},98,"ESTIMATED","INTERVENTIONAL",[48],"NA","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.\n\nCurrently, 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.",[51],"Perimenopausal Insomnia","NOT_YET_RECRUITING","2026-07-10",{"date":55,"type":56},"2026-07-16","ACTUAL",{"date":58,"type":45},"2026-07-01",{"date":60,"type":45},"2027-08-31",{"name":5,"class":6}]