[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100544080":3},{"organization":4,"outcomesModule":7,"designInfo":46,"detailedDescription":59,"studyPopulation":51,"armGroups":60,"interventions":79,"overallOfficials":104,"centralContacts":108,"locations":117,"responsibleParty":140,"collaborators":51,"id":142,"slug":51,"hasResults":143,"nctId":144,"briefTitle":145,"officialTitle":145,"acronym":51,"eligibilityCriteria":146,"healthyVolunteers":147,"sex":148,"minAge":149,"maxAge":51,"enrollmentInfo":150,"targetDuration":51,"studyType":153,"phases":154,"briefSummary":156,"conditions":157,"keywords":159,"overallStatus":120,"whyStopped":51,"lastUpdateSubmitDate":166,"lastUpdatePostDateStruct":167,"startDateStruct":170,"completionDateStruct":172,"leadSponsor":174,"locationsCount":175},{"fullName":5,"class":6},"University of Nebraska","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":21},[9],{"measure":10,"description":11,"timeFrame":12},"Chronic Stress Level in the Past Thirty Days","Participant's chronic ctress levels in the past thirty Days will be assessed by the Perceived Stress Scale (PSS) which asks ten questions about participant stress within the last 30 days. The questions are scored from 0 (\"never\") to 4 (\"very often) with specific items needing to be reverse scored. Higher scores indicate higher levels of perceived stress (a worse outcome). The instrument takes about 5 minutes to complete.","Baseline (Visit 1) and Post-intervention (Visit 2)",[14,17],{"measure":15,"description":16,"timeFrame":12},"Participant Quality of Life","Participant quality of life will be assessed by the Health Organization Quality of Life- Short version (WHO-QOL-BREF) survey which measures general perceptions about quality of life in four aspects: physical health, psychological health, social relationships, and environment. The aspects are scored from 1 ('very poor') to 5 ('very good'). Aspect scores are totaled with higher scores indicating a better outcome. The instrument takes about 15 minutes to complete.",{"measure":18,"description":19,"timeFrame":20},"Blood Oxygen Level Dependent (BOLD) responses in neural areas during the Affective Stroop task (AS) and Empathy and Theory of Mind(EmpaToM) task","Neural level changes will be measured by Functional Magnetic Resonance Imaging (fMRI).","Baseline (Visit 1) and Post-intervention (Visit 2) It will take about 60 minutes to complete at each time point.",[22,26,30,34,37,40,43],{"measure":23,"description":24,"timeFrame":25},"Cognitive Orientation Screening","Participants will complete a brief cognitive orientation screening tool, called the Mini-Mental Status Exam. This will be administered by the research assistant. If the participant scores below 26 on this measure, they will be excluded from the study, as it may indicate potential cognitive issues. The scale ranges from 0 to 30, with higher scores indicating better cognitive performance (better outcomes).","Visit 1 (Baseline visit). It will take about 10 minutes.",{"measure":27,"description":28,"timeFrame":29},"Geriatric Anxiety Scale (GAS-10)","Geriatric Anxiety Scale (GAS-10) will assess 10 Items. The rating scale ranges from 0 to 30 points. Higher scores indicate more severe anxiety (worse outcomes).","Baseline (Visit 1) and Post-intervention (Visit 2) It will take about 5 minutes to complete at each time point.",{"measure":31,"description":32,"timeFrame":33},"Geriatric Depression Scale Short Form (GDS-SF)","Geriatric Depression Scale Short Form (GDS-SF) is a rating scale from 0 to 15 points. Higher scores indicate more likelihood of depression symptoms and need for further assessment of depression (worse outcomes).","Baseline (Visit 1) and Post-intervention (Visit 2) It will take about 7 minutes to complete at each time point.",{"measure":35,"description":36,"timeFrame":12},"Alcohol Use Disorders Identification Test","The Alcohol Use Disorders Identification Test (AUDIT Alcohol Screening Tool) assesses 10 items about alcohol consumption, drinking behaviors, and alcohol-related problems of the caregiver. Total scores range from 0 to 40. Higher scores indicate a greater likelihood of harmful alcohol consumption (worse outcomes). Caregivers will complete the instrument twice, each time taking about 10 minutes to finish.",{"measure":38,"description":39,"timeFrame":12},"Neuropsychiatric Inventory-Questionnaire","The Neuropsychiatric Inventory-Questionnaire (NPI-Q) measures 12 domains. The caregiver selects present or absent for symptoms in each domain of the individual with dementia, then rates the severity of symptoms present in the past month. Each domain is scored from 0 to 3 and all domain scores are totaled. Higher scores indicating more severe symptoms (worse outcomes). This instrument also rates impact of the symptoms of individual with dementia on the caregiver (Distress) in each domain. The Distress of each domain is scored from 0 to 5 and all domain scores are totaled. Higher scores indicating more extreme levels of distress (worse outcomes). Caregivers will complete the instrument twice, each time taking about 5 minutes to finish.",{"measure":41,"description":42,"timeFrame":12},"Quick Dementia Rating Scale","The Quick Dementia Rating Scale (QDRS) measures 10 different domains of daily functioning, mood, and behavior. Caregivers rate the severity of dementia symptoms in each domain about the individual for whom they are providing care. Total scores range from 0 to 30, with higher scores indicating more impairment (worse outcomes). Caregivers will complete the instrument twice, each time taking about 5 minutes to finish.",{"measure":44,"description":45,"timeFrame":12},"The Interpersonal Reactivity Index","The Interpersonal Reactivity Index (IRI) is a multidimensional measure of empathy of the caregiver. This instrument has four subscales: Perspective Taking, Empathic Concern, Personal Distress, and Fantasy. Each subscale has 7 items scored from 0 to 4 with specific items needing to be reverse scored. Higher scores indicate greater empathy (better outcomes). Caregivers will complete the instrument twice, each time taking about 10 minutes to finish.",{"allocation":47,"interventionModel":48,"interventionModelDescription":49,"primaryPurpose":50,"observationalModel":51,"timePerspective":51,"maskingInfo":52},"RANDOMIZED","PARALLEL","Randomized, double-blind, placebo-controlled trial","BASIC_SCIENCE",null,{"masking":53,"maskingDescription":54,"whoMasked":55},"TRIPLE","Double-blind",[56,57,58],"PARTICIPANT","CARE_PROVIDER","INVESTIGATOR","More than 15 million family caregivers provide support for individuals with Alzheimer's disease (AD) or related dementias. This number is expected to grow with the increasing population of persons with dementia (PWD). Stress in caregivers to older adults with chronic diseases is already a significant public health issue because it is associated with multiple negative physical and mental health outcomes for the caregiver (e.g., depression, cardiovascular disease) and can negatively impact the health of the PWD as well. Importantly, stress levels are even higher in female than male caregivers and in caregivers to a PWD than other chronic conditions that affect older adults. One promising candidate to reduce stress and improve quality of life is the endogenous neuropeptide oxytocin (OXT). Intranasal OXT interventions have been shown to successfully reduce stress and increase quality of life in other populations, including patients with borderline personality disorder, Post-traumatic Stress Disorder (PTSD), Anxiety Disorder, and Depressive Disorder. However, currently there is no comprehensive study examining its role in the caregivers to chronic medical\u002Fpsychiatric illnesses including dementia for potential beneficial impact as well as reducing chronic stress levels.\n\nEligible females who are family caregivers to a PWD for a least five hours a week for six consecutive months will be randomly enrolled to one of three groups: 12 IU intranasal oxytocin, 24 IU intranasal oxytocin or placebo. The study drug will be administered daily for 21 days. Surveys and questionnaires that evaluate mental and emotional health and functional magnetic resonance imaging (fMRI) will be administered before and after the study treatment to see if oxytocin will help improve quality of life better and lower stress levels in caregivers to people who have dementia. Additionally, the study will find out if the brain responds to oxytocin.",[61,68,74],{"label":62,"type":63,"description":64,"interventionNames":65},"Intranasal Spray Placebo","PLACEBO_COMPARATOR","Nasal spray of placebo liquid solution is administered as 2 puffs of daily dose (every morning) for 3 weeks. Functional magnetic resonance imaging (fMRI) scan will be done pre- and post-administration.",[66,67],"Drug: Placebo","Procedure: Functional MRI",{"label":69,"type":70,"description":71,"interventionNames":72},"Oxytocin Intranasal Spray 12 International Units","ACTIVE_COMPARATOR","Nasal spray of Oxytocin 12 International Units (12IU) liquid solution as 2 puffs of daily dose (every morning) for 3 weeks. Functional magnetic resonance imaging (fMRI) scan pre- and post-administration.",[73,67],"Drug: Oxytocin Intranasal Spray 12 International Unit (12IU)",{"label":75,"type":70,"description":76,"interventionNames":77},"Oxytocin Intranasal Spray 24 International Units","Nasal spray of Oxytocin 24 International Units (24IU) liquid solution as 2 puffs of daily dose (every morning) for 3 weeks. Functional magnetic resonance imaging (fMRI) scan pre- and post-administration.",[78,67],"Drug: Oxytocin Intranasal Spray 24 International Unit (24IU)",[80,85,91,97],{"type":81,"name":82,"description":83,"armGroupLabels":84,"otherNames":51},"DRUG","Placebo","Placebo intranasal spray liquid with no oxytocin will be delivered in 2 puffs to each nostril daily for 21 days. The first single dose will be administered at the clinic (Visit 1).",[62],{"type":81,"name":86,"description":87,"armGroupLabels":88,"otherNames":89},"Oxytocin Intranasal Spray 12 International Unit (12IU)","Participants weighing less than 40 kg (88 pounds) will receive 12 IU of oxytocin delivered as 1 puff (6 IU) to each nostril daily for 21 days. The first single dose will be administered at the clinic (Visit 1).",[69],[90],"Oxytocin 12IU",{"type":81,"name":92,"description":93,"armGroupLabels":94,"otherNames":95},"Oxytocin Intranasal Spray 24 International Unit (24IU)","Participants weighing more than 40 kg (880 pounds) will receive 24 IU of oxytocin delivered as 2 puffs (12 IU) to each nostril daily for 21 days. The first single dose will be administered at the clinic (Visit 1).",[75],[96],"Oxytocin 24IU",{"type":98,"name":99,"description":100,"armGroupLabels":101,"otherNames":102},"PROCEDURE","Functional MRI","Functional MRI (fMRI) scan with affective Stroop and Empathy and Theory of Mind task (EmpaTom task will administered pre- and post-administration of oxytocin.",[62,69,75],[103],"fMRI",[105],{"name":106,"affiliation":5,"role":107},"Soonjo Hwang, MD","PRINCIPAL_INVESTIGATOR",[109,113],{"name":106,"role":110,"phone":111,"phoneExt":51,"email":112},"CONTACT","402-552-6351","soonjo.hwang@unmc.edu",{"name":114,"role":110,"phone":115,"phoneExt":51,"email":116},"Minjoo Kang, MEd","402-552-6239","mkang@unmc.edu",[118],{"facility":119,"status":120,"city":121,"state":122,"zip":123,"country":124,"countryCode":125,"cosmosGeoPoint":126,"geoPoint":131,"contacts":132},"University of Nebraska Medical Center, Department of Psychiatry","RECRUITING","Omaha","Nebraska","61898-5581","United States","US",{"type":127,"coordinates":128},"Point",[129,130],-95.94043,41.25626,{"lat":130,"lon":129},[133,136,137],{"name":134,"role":110,"phone":115,"phoneExt":51,"email":135},"Chase Brice, B.S.","cbrice@unmc.edu",{"name":106,"role":107,"phone":51,"phoneExt":51,"email":51},{"name":138,"role":139,"phone":51,"phoneExt":51,"email":51},"Janelle N Beadle, PhD","SUB_INVESTIGATOR",{"type":141,"investigatorFullName":51,"investigatorTitle":51,"investigatorAffiliation":51,"oldNameTitle":51,"oldOrganization":51},"SPONSOR","100544080",false,"NCT06364228","Intranasal Oxytocin Intervention for Caregivers to Persons With Dementia","Inclusion Criteria:\n\n* Females 50 years of age or older\n* Currently an unpaid family caregiver to an older adult (50 years and older) with dementia for at least five hours a week for at least six months\n* Normal or corrected to normal vision and hearing\n* Mobility to travel to University of Nebraska Medical Center (UNMC) for study procedures including brain imaging\n* Right-handed\n* Capacity to read and write English\n\nExclusion Criteria:\n\n* Major medical illness that contraindicates oxytocin (OXT) administration (e.g., severe liver disease, seizure disorder, metabolic disorder)\n* History of allergic reaction to oxytocin (OXT) and its nasal spray product\n* History of central nervous system (CNS) disease, including history of seizure, epilepsy, CNS tumor, CNS hemorrhage, or serious CNS infection including meningitis or encephalitis\n* Currently pregnant or planning to become pregnant during the course of the study\n* Metal in the body (i.e., hearing aid, cardiac pacemaker, bone plates, braces, non-removable piercing\u002Fimplants, etc.), claustrophobia, or any other condition that would preclude magnetic resonance imaging (MRI) scanning\n* Mini-mental status exam score of 25 or lower which suggests possible cognitive issues\n* History of or current neurological disease (e.g., stroke, traumatic brain injury, brain tumor, dementia)\n* History of or current severe psychiatric disease (e.g., schizophrenia, bipolar disorder, autism, severe post-traumatic stress disorder)\n* History of, or current drug or alcohol abuse\n* Currently breastfeeding\n* Current coronavirus disease-19 (COVID-19) illness\n* Left-handed due to brain structural difference between right and left-handed individuals\n* Currently taking antipsychotic medications, selective serotonin reuptake inhibitors (SSRIs) or corticosteroid creams\u002Fpills",true,"FEMALE","50 Years",{"count":151,"type":152},32,"ESTIMATED","INTERVENTIONAL",[155],"PHASE2","More than 15 million family caregivers provide support for individuals with Alzheimer's disease (AD) or related dementias. This number is expected to grow with the increasing population of persons with dementia (PWD). Stress in caregivers to older adults with chronic diseases is already a significant public health issue because it is associated with multiple negative physical and mental health outcomes for the caregiver (e.g., depression, cardiovascular disease) and can negatively impact the health of the PWD as well. Importantly, stress levels are even higher in female than male caregivers and in caregivers to PWD than other chronic conditions that affect older adults.\n\nThere are numerous interventions to improve well-being in caregivers to PWD, but only two have been shown to moderately improve caregiver depression and quality of life in the PWD. However, both of the interventions are time and energy intensive. One promising candidate to reduce stress and improve quality of life is the endogenous neuropeptide oxytocin (OXT). Intranasal OXT interventions have been shown to successfully reduce stress and increase quality of life in other populations, including patients with borderline personality disorder, Post-traumatic Stress Disorder (PTSD), Anxiety Disorder, and Depressive Disorder. This study will assess the efficacy and safety of intranasal oxytocin (OXT) to improve the quality of life and reduce chronic stress levels in the caregivers to PWD. Participants will be randomly enrolled to one of three groups: 12 IU intranasal oxytocin, 24 IU intranasal oxytocin or placebo. The study drug will be administered daily for 21 days.",[158],"Stress",[160,161,162,163,103,164,165],"Oxytocin","Stress level","Caregivers","Dementia","Neuroimaging","Quality of Life","2026-04-30",{"date":168,"type":169},"2026-05-05","ACTUAL",{"date":171,"type":152},"2026-06-20",{"date":173,"type":152},"2027-06",{"name":5,"class":6},1]