[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Heart and Brain Research Group, Germany\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":152},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,48,84,105,130],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":22,"conditions":23,"keywords":28,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":4},"100639710","prospective-neuropsychological-evaluation-of-the-implementation-of-a-heart-valve-unit-hvu-neuro-100639710",false,"NCT07626567","Prospective Neuropsychological Evaluation of the Implementation of a Heart Valve Unit (HVU-NEURO)","HVU-NEURO","Inclusion Criteria:\n\n* Severe aortic valve stenosis\n* Indication for transcatheter valve therapy according to current guideline recommendations and\u002For Heart-Team consensus\n* Sufficient German language proficiency, as study-related tests, questionnaires, and instructions are administered in German\n* Age ≥18 years\n* Willingness to participate voluntarily with written informed consent\n\nExclusion Criteria:\n\n* Known pregnancy at the time of study inclusion\n* Life expectancy \\\u003C1 year due to non-cardiac disease\n* Pre-interventional psychiatric and neurological disorders (known and diagnosed dementia, depression, history of stroke or transient ischemic attack \\[TIA\\], migraine, epilepsy) with acute symptoms that may interfere with data collection","ALL","18 Years",{"count":19,"type":20},500,"ESTIMATED","OBSERVATIONAL","Transcatheter aortic valve implantation (TAVI) is an established treatment for severe aortic stenosis. Despite improved procedural outcomes, neurocognitive complications such as postoperative delirium (POD) and postoperative cognitive decline (POCD) remain clinically relevant.\n\nHeart Valve Units (HVU) are specialized interdisciplinary care structures designed to improve treatment pathways and healthcare quality. However, their impact on neuropsychological outcomes has not been sufficiently investigated.\n\nHVU-NEURO is a prospective observational cohort study evaluating neuropsychological outcomes before and after implementation of an HVU. Approximately 500 patients undergoing transcatheter valve therapy will be included.\n\nNeurocognitive function will be assessed before intervention, at hospital discharge, and three months after intervention. POD will be assessed using the Intensive Care Delirium Screening Checklist (ICDSC). The primary objective is to evaluate the effect of HVU implementation on postoperative cognitive decline at discharge from acute hospital care.",[24,25,26,27],"Aortic Valve Stenosis","Postoperative Cognitive Dysfunction (POCD)","Delirium - Postoperative","Neurocognitive Disorders",[29,30,31,32,33,34,35],"TAVI","HVU","Postoperative Cognitive Decline","Postoperative Delirium","Neuropsychology","Transcatheter Aortic Valve Implantation","Intensive Care Delirium Screening Checklist","NOT_YET_RECRUITING","2026-05-29",{"date":39,"type":40},"2026-06-04","ACTUAL",{"date":42,"type":20},"2026-05-25",{"date":44,"type":20},"2028-02",{"name":46,"class":47},"Heart and Brain Research Group, Germany","OTHER",{"id":49,"slug":50,"hasResults":11,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":54,"eligibilityCriteria":55,"healthyVolunteers":56,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":57,"targetDuration":4,"studyType":59,"phases":60,"briefSummary":62,"conditions":63,"keywords":68,"overallStatus":74,"whyStopped":4,"lastUpdateSubmitDate":75,"lastUpdatePostDateStruct":76,"startDateStruct":78,"completionDateStruct":80,"leadSponsor":82,"locationsCount":83},"100622706","decreasing-stress-via-virtual-reality-and-binaural-beats-in-non-clinical-adults-100622706","NCT07387107","Decreasing Stress Via Virtual Reality and Binaural Beats in Non-Clinical Adults","Decreasing Stress Via Virtual Reality and Binaural Beats in Non-Clinical Adults: A Randomized Controlled Study.","DESTUD","Inclusion Criteria:\n\n1\\. Adults aged 18 years or older 2. Ability to understand study procedures and provide written informed consent 3. Sufficient proficiency in the German language to complete questionnaires and follow study instructions 4. Willingness to participate in a single approximately 60-minute study session\n\nExclusion Criteria:\n\n1\\. Current or history of neurological or psychiatric disorders that may interfere with data collection (e.g., dementia, major depressive disorder, stroke, epilepsy) 2. Severe visual or hearing impairments that would limit the use of virtual reality equipment or headphones 3. History of adverse reactions to virtual reality",true,{"count":58,"type":20},52,"INTERVENTIONAL",[61],"NA","This study is a non-clinical substudy conducted within the DESTRESS research program (NCT05036538), which investigates the effects of relaxation interventions on physiological and psychological parameters. While the main DESTRESS trial focuses on cardiac surgical patients, this additional study arm examines the same interventions in a non-clinical adult population under controlled conditions, independent of disease-, surgery-, or medication-related influences.\n\nParticipants are randomly assigned to one of several experimental conditions and take part in a single approximately 30-minute session. Depending on group allocation, the session may include exposure to natural soundscapes, natural soundscapes combined with binaural beats, virtual reality-based natural environments, virtual reality combined with binaural beats, or a control condition without a relaxation intervention.\n\nThe primary aim of the DESTUD-Study is to assess the feasibility and potential stress-reducing effects of these non-pharmacological relaxation approaches in a non-clinical setting and to support the interpretation of findings from the clinical DESTRESS trial. Physiological responses, including heart rate variability and electrodermal activity, as well as self-reported stress measures, are collected before, during and after the conditions.",[64,65,66,67],"Stress","Relaxation","Virtual Reality","Binaural Beats",[66,67,69,70,71,72,73],"Heart Rate Variability","Stress Reduction","Relaxation Intervention","Non-Clinical Population","Electrodermal Activity","RECRUITING","2026-03-11",{"date":77,"type":40},"2026-03-13",{"date":79,"type":40},"2026-03-05",{"date":81,"type":20},"2026-07-15",{"name":46,"class":47},1,{"id":85,"slug":86,"hasResults":11,"nctId":87,"briefTitle":88,"officialTitle":89,"acronym":90,"eligibilityCriteria":91,"healthyVolunteers":56,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":92,"targetDuration":4,"studyType":59,"phases":94,"briefSummary":95,"conditions":96,"keywords":97,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":98,"lastUpdatePostDateStruct":99,"startDateStruct":101,"completionDateStruct":102,"leadSponsor":104,"locationsCount":4},"100626152","effects-of-nature-based-virtual-reality-and-binaural-beats-on-heart-rate-variability-and-relaxation-100626152","NCT07431918","Effects of Nature-Based Virtual Reality and Binaural Beats on Heart Rate Variability and Relaxation","Effects of Nature-Based Virtual Reality and Binaural Beats on Heart Rate Variability and Relaxation: A Controlled Within-Subject Study","VRELAX","Inclusion Criteria:\n\n* Adults aged 18 years or older\n* Ability to understand study procedures and provide written informed consent\n* Sufficient proficiency in the German language to complete questionnaires and follow study instructions\n* Willingness to participate in a single approximately 60-minute study session\n\nExclusion Criteria:\n\n* Current or history of neurological or psychiatric disorders that may interfere with data collection (e.g., dementia, major depressive disorder, stroke, epilepsy)\n* Severe visual or hearing impairments that would limit the use of virtual reality equipment or headphones\n* History of adverse reactions to virtual reality",{"count":93,"type":20},18,[61],"The VRELAX study is a non-clinical sub-study within the \"Decreasing Preoperative Stress to Prevent Postoperative Delirium and Postoperative Cognitive Decline in Cardiac Surgical Patients\"- research program (DESTRESS; NCT05036538), which investigates non-pharmacological relaxation interventions using virtual reality and binaural auditory stimulation. In a randomized counterbalanced within-subject design, non-clinical adult participants complete two sessions separated by a 1 day intervention-free interval. A 30-minute immersive nature-based virtual reality exposure combined with gradually decreasing binaural beats (10-1 Hertz (Hz)), and a control condition without relaxation. Heart rate variability (HRV) is recorded continuously, and subjective stress is assessed before and after each condition. The primary outcome is parasympathetic activation operationalized as high-frequency (HF) power of heart rate variability. Secondary outcomes include additional HRV parameters and self-reported stress ratings. The study aims to characterize short-term relaxation effects and evaluate the feasibility of independent use in everyday settings, supporting interpretation of clinical findings of the DESTRESS trial.",[64,65,66,67],[66,67,69,70,71,72],"2026-02-18",{"date":100,"type":40},"2026-02-25",{"date":100,"type":20},{"date":103,"type":20},"2026-12-20",{"name":46,"class":47},{"id":106,"slug":107,"hasResults":11,"nctId":108,"briefTitle":109,"officialTitle":110,"acronym":111,"eligibilityCriteria":112,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":113,"targetDuration":4,"studyType":59,"phases":115,"briefSummary":116,"conditions":117,"keywords":120,"overallStatus":74,"whyStopped":4,"lastUpdateSubmitDate":122,"lastUpdatePostDateStruct":123,"startDateStruct":125,"completionDateStruct":127,"leadSponsor":129,"locationsCount":83},"100442065","decreasing-preoperative-stress-to-prevent-postoperative-delirium-and-postoperative-cognitive-decline-in-cardiac-surgical-patients-100442065","NCT05036538","Decreasing Preoperative Stress to Prevent Postoperative Delirium and Postoperative Cognitive Decline in Cardiac Surgical Patients.","Decreasing Preoperative Stress to Prevent Postoperative Delirium and Postoperative Cognitive Decline in Cardiac Surgical Patients. A Randomized Controlled Trial on Relaxation Interventions Via Virtual Reality and Binaural Beats.","DESTRESS-SURG","Inclusion Criteria:\n\n1. Elective cardiac surgery (coronary artery bypass surgery, aortic or mitral valve replacement\u002Freconstruction, or combination surgery) with standardized extracorporeal circulation.\n2. A sufficiently good knowledge of German is necessary as neuropsychological tests are language-dependent.\n\nExclusion Criteria:\n\n1. History of acute clinically relevant cognitive impairment of any cause (e.g., dementia, depression, stroke, multiple sclerosis) that may impair neuropsychological evaluation.\n2. Contraindications to the presentation of binaural beats or visual stimuli (e.g., epilepsy),\n3. Significant hearing loss or astigmatism, which may interfere with optimal perception of auditory and visual stimuli.\n4. Taking sedatives on the day of surgery.\n5. Unwilling to participate in the relaxation procedure or neuropsychological testing due to deteriorating health, lack of motivation, or other reasons.\n6. Participation in interventions that aim to change cognitive or emotional functioning which cannot be systematically controlled by our study team.\n7. Participation in an interventional study according to AMG\u002FMPG will also be excluded.\n8. Patients with missing informed consent.",{"count":114,"type":20},125,[61],"Patients undergoing cardiac surgery often complain of anxiety before a major operation and the resulting stress. This circumstance is a risk factor for mental problems that may occur after the operation (e.g., delirium or memory deficits). This study aims to prevent these discomforts by a preoperative relaxation intervention.",[118,119,32],"Preoperative Stress","Postoperative Cognitive Dysfunction",[121,31,32,118,71,66,67],"Cardiac Surgery","2026-02-13",{"date":124,"type":40},"2026-02-17",{"date":126,"type":40},"2023-07-27",{"date":128,"type":20},"2028-11",{"name":46,"class":47},{"id":131,"slug":132,"hasResults":11,"nctId":133,"briefTitle":134,"officialTitle":135,"acronym":136,"eligibilityCriteria":137,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":138,"targetDuration":4,"studyType":59,"phases":140,"briefSummary":141,"conditions":142,"keywords":143,"overallStatus":74,"whyStopped":4,"lastUpdateSubmitDate":122,"lastUpdatePostDateStruct":146,"startDateStruct":147,"completionDateStruct":149,"leadSponsor":151,"locationsCount":83},"100400420","increasing-preoperative-cognitive-reserve-to-prevent-postoperative-cognitive-dysfunction-in-cardiac-surgical-patients-100400420","NCT04493996","Increasing Preoperative Cognitive Reserve to Prevent Postoperative Cognitive Dysfunction in Cardiac Surgical Patients","Increasing Preoperative Cognitive Reserve to Prevent Postoperative Delirium and Postoperative Cognitive Decline in Cardiac Surgical Patients. A Randomized Controlled Trial on Cognitive Training","INCORE","Inclusion Criteria:\n\n* Elective cardiac surgery (coronary artery bypass surgery, aortic or mitral valve replacement\u002Freconstruction, or combination surgery) with standardized extracorporeal circulation\n* A sufficiently good knowledge of German is necessary as cognitive training and neuropsychological tests are language-dependent\n\nExclusion Criteria:\n\n* History of stroke and preexisting psychiatric or neurological disorders that may impair the neuropsychological performance",{"count":139,"type":20},100,[61],"Postoperative delirium (POD) and postoperative cognitive decline (POCD) can be observed after cardiosurgical interventions. Taken together, these postoperative neurocognitive dysfunctions contribute to increased morbidity and mortality and higher economic costs. Preoperative risk factors of postoperative neurocognitive dysfunctions, such as decreased neuropsychometric performance or decreased cognitive daily activities, can be interpreted as reduced cognitive reserve. The aim of this study is to build up cognitive reserves to protect against the development of POD and POCD through preoperative, home-based, cognitive training.",[31,32,119],[121,31,32,144,145,119],"Cognitive Training","Cognitive Reserve",{"date":124,"type":40},{"date":148,"type":40},"2020-08-14",{"date":150,"type":20},"2026-03",{"name":46,"class":47},""]