[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"perimenopausal-insomnia\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:perimenopausal-insomnia":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,53],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":23,"conditions":24,"keywords":33,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":41,"lastUpdatePostDateStruct":42,"startDateStruct":45,"completionDateStruct":47,"leadSponsor":49,"locationsCount":52},"100594705","a-trial-to-investigate-the-accuracy-of-a-wearable-device-in-collecting-data-related-to-perimenopausal-symptoms-in-women-100594705",false,"NCT07022925","A Trial to Investigate the Accuracy of a Wearable Device in Collecting Data Related to Perimenopausal Symptoms in Women","An Observational Virtual Trial to Investigate the Accuracy of a Wearable Device in Collecting Data Related to Perimenopausal Symptoms in Women","Inclusion Criteria:\n\n1. Females between 35-55 years of age, inclusive\n2. Self-reported perimenopausal women experiencing hot flushes or night sweats\n3. Individuals of child-bearing potential must confirm they are not pregnant, do not plan to become pregnant, and agree to use a medically approved method of birth control for the duration of the study. Acceptable methods of birth control include:\n\n   * Double-barrier method\n   * Intrauterine devices\n   * Non-heterosexual lifestyle or agrees to use contraception if planning on changing to heterosexual partner(s)\n   * Vasectomy of partner at least 6 months prior to screening\n   * Abstinence\n4. Agrees to maintain current lifestyle as much as possible throughout the study, including diet, exercise, supplements\u002Fmedications, and sleep\n5. Provided voluntary and informed consent to participate in the study\n6. Generally healthy as determined by medical history with no unstable diagnosed medical conditions\n\nExclusion Criteria:\n\n1. Allergy or sensitivity to adhesive used for wearing the investigational device\n2. Self-reported use of a pacemaker\n3. Self-reported unstable diagnosed anxiety disorder\n4. Self-reported sleep disorder requiring medical treatment\n5. Self-reported skin conditions or sensitive skin around the area of application\n6. Self-reported surgery in the past three months or individuals who have planned surgery during the course of the study\n7. Alcohol intake average of ˃1 standard drink per day\n8. Alcohol or drug abuse within the last 12 months that has required treatment\n9. Current use of prescribed and\u002For over-the-counter (OTC) medications\u002Fsupplements that may impact data recorded by the investigational device (see Section 7.3)\n10. Participation in other clinical research studies 30 days prior to screening\n11. Individuals who are unable to give informed consent\n12. Any other condition or lifestyle factor, that may adversely affect the participant's ability to complete the study or its measures or pose significant risk to the participant","FEMALE","35 Years","55 Years",{"count":20,"type":21},110,"ESTIMATED","OBSERVATIONAL","The goal of this observational study is to investigate the accuracy of the device in characterizing perimenopausal and menopausal symptoms including vasomotor symptoms, anxiety, sleep quality compared to self-reported symptoms via an app. The main question it aims to answer is:\n\nWhat is the accuracy of the developed algorithm from the investigational device compared to daily self-report via an app in characterizing perimenopausal symptoms?\n\nParticipants will be asked to wear IndentifyHer's wearable non-invasive sensor and complete a daily electronic diary and questionnaires on stress, anxiety, and sleep.",[25,26,27,28,29,30,31,32],"Perimenopause","Perimenopausal Depression","Perimenopausal Insomnia","Perimenopausal Women","Menopausal Depression","Menopausal Hot Flashes","Menopausal and Postmenopausal Disorders","Menopausal Vasomotor Symptoms",[34,25,35,36,37,38,39],"Menopause","Vasomotor symptoms","Hot flashes","IdentifyHer","Peri","Perimenopausal symptoms","RECRUITING","2025-09-17",{"date":43,"type":44},"2025-09-18","ACTUAL",{"date":46,"type":44},"2025-07-04",{"date":48,"type":21},"2025-10",{"name":50,"class":51},"IdentifyHer Limited","INDUSTRY",1,{"id":54,"slug":55,"hasResults":11,"nctId":56,"briefTitle":57,"officialTitle":58,"acronym":59,"eligibilityCriteria":60,"healthyVolunteers":11,"sex":16,"minAge":61,"maxAge":18,"enrollmentInfo":62,"targetDuration":4,"studyType":64,"phases":65,"briefSummary":67,"conditions":68,"keywords":69,"overallStatus":71,"whyStopped":4,"lastUpdateSubmitDate":72,"lastUpdatePostDateStruct":73,"startDateStruct":75,"completionDateStruct":77,"leadSponsor":79,"locationsCount":52},"100581908","auricular-acupressure-for-perimenopausal-insomnia-100581908","NCT06856421","Auricular Acupressure for Perimenopausal Insomnia","Auricular Acupressure for Perimenopausal Insomnia: A Multicenter Randomized Controlled Clinical Trial","Acupressure","Inclusion Criteria:\n\n* Age between 45 and 55 years;\n\n  * Meetingperimenopause defined by the Staging of Reproductive Aging Workshop (STRAW);\n\n    * Patients must satisfy at least one diagnostic criterion for insomnia in the Diagnostic and Statistical Manual of Mental Disorders (DSM-5); ④ Nighttime sleep disturbances and associated perimenopausal symptoms persisting for at least 4 weeks; ⑤ No use, or stable long-term use (\\>2 months) of medications for treating insomnia;\n\n      * No prior auricular acupuncture therapy, good compliance, understanding of the study protocol, and signed informed consent.\n\nExclusion Criteria:\n\n* Does not meet inclusion criteria;\n\n  * Non-natural menopausal transition due to premature ovarian failure, drug intake, or surgeries (e.g., oophorectomy);\n\n    * Currently pregnant or breastfeeding;\n\n      * Insomnia caused by systemic diseases (e.g., stroke, Parkinson's disease, surgery, etc.);\n\n        * Presence of insomnia symptoms before the perimenopausal period;\n\n          * Infection in the areas near selected acupoints; ⑦ History of alcohol or substance abuse\u002Faddiction；\n\n            * Co-existing mental or psychological disorders (e.g., depression, generalized anxiety disorder, bipolar disorder, obsessive-compulsive disorder, etc.) or suicidal tendencies, in addition to insomnia; ⑨ Receipt of auricular acupuncture therapy within the past 3 months; ⑩ Participation in other clinical trials in the past 3 months;\n\n              * Any known chronic pain disorders that could affect sleep.","45 Years",{"count":63,"type":21},160,"INTERVENTIONAL",[66],"NA","This clinical trial aims to determine whether auricular Acupressure therapy can improve symptomatic insomnia in perimenopausal women.\n\nCan ear acupressure therapy significantly improve sleep quality in perimenopausal women with insomnia? What medical issues or adverse reactions might participants experience during the treatment? Researchers will compare ear acupressure therapy with traditional treatments in a control group to assess its effectiveness and safety.\n\nParticipants will:\n\nReceive auricular acupressure on Monday and Thursday, applying pressure for 3 consecutive days each week. This process will continue for 4 weeks, totaling 8 sessions.\n\nRecord assessment points as follows: Baseline (2 weeks before treatment to Week 0), mid-treatment (2 weeks after treatment begins), end of treatment (4 weeks after treatment begins), and follow-up (4 weeks after treatment ends) for primary and secondary outcome indicators. Eight weeks after treatment concludes, only the primary outcome indicator (Insomnia Severity Index) will be recorded.\n\nThis trial seeks to evaluate the potential benefits and safety profile of auricular acupressure therapy for managing insomnia in perimenopausal women.",[27],[27,70],"Auricular point","NOT_YET_RECRUITING","2025-04-26",{"date":74,"type":44},"2025-04-30",{"date":76,"type":21},"2025-06-01",{"date":78,"type":21},"2026-12-30",{"name":80,"class":81},"The First Affiliated Hospital of Zhejiang Chinese Medical University","OTHER"]