[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"isolated-rem-sleep-behavior-disorder\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:isolated-rem-sleep-behavior-disorder":24},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":17,"targetDuration":4,"studyType":20,"phases":4,"briefSummary":21,"conditions":22,"keywords":25,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":42},"100631267","unmet-needs-among-patients-with-isolated-rem-sleep-behavior-disorder-irbd-and-their-significant-others-100631267",false,"NCT07498452","Unmet Needs Among Patients With Isolated REM Sleep Behavior Disorder (iRBD) and Their Significant Others","Exploring Unmet Needs Among Patients With Isolated REM Sleep Behavior Disorder (iRBD) and Their Significant Others: A Multicenter Cross-Sectional Survey Study","Inclusion Criteria:\n\n* Patients diagnosed with iRBD according to the International Classification of Sleep Disorders, 3rd Edition (ICSD-3) criteria.\n* Patients who have had a follow-up visit within the previous 12 months.\n* Patients who provide informed consent to participate in the study.\n* Partners\u002Ffamily members of patients with iRBD who accept to participate.\n\nExclusion Criteria:\n\n* Patients with RBD who have already phenoconverted to a neurodegenerative disorder.\n* Patients or partners\u002Ffamily members without access to an email address.","ALL",{"count":18,"type":19},150,"ESTIMATED","OBSERVATIONAL","The goal of this observational study is to explore the unmet needs and the psychosocial impact of isolated REM Sleep Behavior Disorder (iRBD) on patients and their significant others. Isolated REM Sleep Behavior Disorder is a sleep disorder characterized by dream-enactment behaviors during REM sleep and is increasingly recognized as a prodromal condition associated with neurodegenerative diseases. Despite growing clinical attention, little is known about the informational, emotional, and practical needs experienced by patients and their caregivers.\n\nThe main questions this study aims to answer are:\n\nWhat are the main unmet informational, psychological, and clinical needs reported by patients with isolated REM Sleep Behavior Disorder?\n\nWhat are the main challenges and support needs experienced by their significant others or caregivers?\n\nHow does the diagnosis of iRBD affect quality of life, emotional well-being, and perceptions of future health risks for both patients and caregivers?\n\nThis is a multicenter cross-sectional observational study conducted in several sleep and movement disorders centers. The study aims to collect structured information directly from patients and their significant others in order to better understand their experiences, concerns, and expectations regarding the disease and its management.\n\nParticipants will be asked to:\n\ncomplete an online questionnaire about their experience with isolated REM Sleep Behavior Disorder, including perceived needs, access to information, and interactions with healthcare services;\n\nreport information about emotional well-being, quality of life, and concerns related to the possible future progression of the disorder;\n\ncaregivers or significant others will complete a parallel questionnaire focused on their experiences, caregiving burden, informational needs, and perceived support.\n\nThe information collected in this study will help clinicians and researchers better understand the real-world needs of individuals living with isolated REM Sleep Behavior Disorder and their families. The results may contribute to improving patient education, clinical care pathways, and support services for this population.",[23,24],"REM Sleep Behavior Disorder","Isolated REM Sleep Behavior Disorder",[26,23,27,28,29],"iRBD","Prodromal Parkinsonism","Patient Needs","Sleep Disorders","RECRUITING","2026-03-25",{"date":33,"type":34},"2026-03-27","ACTUAL",{"date":36,"type":34},"2025-05-06",{"date":38,"type":19},"2026-08",{"name":40,"class":41},"Universita di Verona","OTHER",8]