[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100539635":3},{"organization":4,"armGroups":7,"interventions":27,"overallOfficials":40,"centralContacts":48,"locations":17,"responsibleParty":57,"collaborators":17,"id":60,"slug":61,"hasResults":62,"nctId":63,"briefTitle":64,"officialTitle":65,"acronym":17,"eligibilityCriteria":66,"healthyVolunteers":62,"sex":67,"minAge":68,"maxAge":69,"enrollmentInfo":70,"targetDuration":17,"studyType":73,"phases":74,"briefSummary":76,"conditions":77,"keywords":17,"overallStatus":80,"whyStopped":17,"lastUpdateSubmitDate":81,"lastUpdatePostDateStruct":82,"startDateStruct":85,"completionDateStruct":87,"leadSponsor":89,"locationsCount":17},{"fullName":5,"class":6},"VU University of Amsterdam","OTHER",[8,14,18,23],{"label":9,"type":10,"description":11,"interventionNames":12},"MHT","EXPERIMENTAL","Participants will receive the standard care menopausal hormone therapy.",[13],"Drug: Estrogens and Progestogens",{"label":15,"type":10,"description":16,"interventionNames":17},"Sleep modules","Participants will receive the sleep modules, which includes cognitive behavioral therapy for insomnia, and circadian rhythm therapy.",null,{"label":19,"type":10,"description":20,"interventionNames":21},"MHT and Sleep modules","Participants will receive both the sleep modules, which includes cognitive behavioral therapy for insomnia, and circadian rhythm therapy, and the standard care menopausal hormone therapy.",[13,22],"Behavioral: Cognitive behavioral therapy for insomnia (CBTi), and circadian rhythm therapy",{"label":24,"type":25,"description":26,"interventionNames":17},"No intervention","NO_INTERVENTION","The control group.",[28,35],{"type":29,"name":30,"description":31,"armGroupLabels":32,"otherNames":33},"DRUG","Estrogens and Progestogens","Menopausal Hormone Therapy, formerly known as Hormone Replacement Therapy (HRT), is a medical treatment that involves the use of hormones to relieve the symptoms of menopause and to reduce the risk of certain long-term health conditions associated with menopause. Menopause is a natural biological process that occurs when a women's ovaries stop producing effects, and her estrogen and progesteron hormone levels subsequently decrease. MHT typically involves administration of a combination of sec steroids.\n\nIn this study MHT consists of estradiol transdermal patches (50 mcg (Systen), which provide a stable release of estradiol and lead to more stable blood levels. This is combined with 200 mg progesterone (Utrogestan tablets for 2 weeks) adjusted to the menstrual cycle to prevent endometrium carcinoma according to the international MHT guidelines.",[9,19],[34],"Hormone replacement therapy",{"type":36,"name":37,"description":38,"armGroupLabels":39,"otherNames":17},"BEHAVIORAL","Cognitive behavioral therapy for insomnia (CBTi), and circadian rhythm therapy","CBTi is a guided, internet-based cognitive behavioral therapy program for insomnia, containing information and exercises on sleep. It consists of five online sessions:\n\n1. Psycho-education on sleep, disordered sleep and sleep hygiene (i.e. general guidelines about health and environmental factors influencing sleep),\n2. Sleep restriction (i.e. restrict time in bed to the average sleep time) and stimulus control training (i.e. reinforce association of bed with sleeping),\n3. Rumination and relaxation techniques,\n4. Cognitive restructuring (i.e. changing misconceptions about sleep),\n5. Relapse prevention.",[19],[41,45],{"name":42,"affiliation":43,"role":44},"Birit Broekman, Prof.","OLVG and Amsterdam UMC, VU","PRINCIPAL_INVESTIGATOR",{"name":46,"affiliation":47,"role":44},"Eus van Someren, Prof.","Netherlands Institute for Neuroscience",[49,54],{"name":50,"role":51,"phone":52,"phoneExt":17,"email":53},"Anne-Sophie Koning, Dr.","CONTACT","+31 20 566 5500","a.koning@nin.knaw.nl",{"name":55,"role":51,"phone":52,"phoneExt":17,"email":56},"Francesca van Baarzel, MSc.","f.van.baarzel@nin.knaw.nl",{"type":44,"investigatorFullName":58,"investigatorTitle":59,"investigatorAffiliation":5,"oldNameTitle":17,"oldOrganization":17},"Birit Broekman","Prof. dr. MD","100539635","phase-4-sleeping-through-menopause-100539635",false,"NCT06306404","Sleeping Through Menopause","The Role of Online Sleep Intervention and Hormone Therapy on Sleep, Climacteric Symptoms and Mood in the Perimenopause","Inclusion Criteria:\n\n* Age between 40-55 years old\n* Insomnia severity index score =\\>10\n* Green Climacteric Score =\\>13\n* Self-considered capability of completing online questionnaires and diaries in Dutch\u002FEnglish\n* Presence of a menstruation (whether regular or not) and the last menstruation must be less than 12 months ago\n\nExclusion Criteria:\n\n* CBTi treatment in past year\n* Bipolar disorder or psychotic disorder\n* Contra-indication for Menopausal Hormone Therapy\n* Alcohol or drugs dependency (scores of ≥ 20 on the AUDIT and ≥25 on the DUDIT)\n* Women using thyroid medication, lamotrigine, aromatase, tamoxifen, because of interaction effects with MHT\n* Use of drugs known to interfere with cytochrome P450 enzyme (CYP) 3A4\n* Known hypersensitivity to the excipients in the estradiol patch: acrylate copolymer, polyethylene terephthalate, alfa-tocopherol, soy allergy (component of progesterone capsule).\n* All women on hormonal contraceptives will be excluded.\n* All women already on MHT will be excluded.","FEMALE","40 Years","55 Years",{"count":71,"type":72},222,"ESTIMATED","INTERVENTIONAL",[75],"PHASE4","Sleepless nights during the menopausal period: what treatment works? About half of the women have trouble sleeping during the years around the menopause, the perimenopause. This is a period characterised by fluctuating sex hormones. Insomnia during the perimenopause can make women more likely to develop more severe climacteric symptoms and other mental health problems. It is therefore important to find the right treatment to treat insomnia. Currently, we do not know what the best treatment is for managing insomnia during the perimenopause. The Sleeping Through Menopause study is the first to evaluate, side by side, two interventions: menopausal hormone therapy (MHT) and combined cognitive behavioural and circadian therapy for insomnia (CBCTi). The study aims to evaluate how well these treatments alleviate insomnia and climacteric symptoms including hot flashes, and by doing so alleviate or prevent other mental health issues. It will also explore how personal factors might affect treatment success.\n\nIn the study, 222 women with both insomnia and climacteric symptoms will be randomly assigned to one of four groups: MHT, CBCTi, a combination of both MHT and CBCTi, or a group with no treatment. The main goal is to evaluate how each treatment alleviates insomnia after 8 and 15 weeks. Secondary outcomes are sleep quality, climacteric symptoms including hot flashes, mental health, and daily functioning.\n\nThis study will help us understand the best ways to treat sleep problems during menopause and whether better sleep can improve other mental health and menopausal symptoms as well.",[78,79],"Menopause","Insomnia","NOT_YET_RECRUITING","2025-08-18",{"date":83,"type":84},"2025-08-24","ACTUAL",{"date":86,"type":72},"2025-10-01",{"date":88,"type":72},"2030-01-01",{"name":5,"class":6}]