[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"syncope-and-collapse\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:syncope-and-collapse":28},{"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":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":29,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":4},"100576707","phase-2-effectiveness-of-a-wearable-hydration-device-100576707",false,"NCT06788795","Effectiveness of a Wearable Hydration Device","Clinical Effectiveness of a Wearable Hydration Device","DRINK","Inclusion Criteria:\n\n* adult patients aged 55 and over\n* rresenting to the emergency department\n* clinical suspicion of dehydration\n* treatment of dehydration\u002Fsyncope with fluid resuscitation\n* English speaking\n\nExclusion Criteria:\n\n* Refusal or inability to give informed consent,\n* severe clinical symptom requiring escalation of care beyond fluid resuscitation (ex. vasopressors, invasive blood pressure monitoring)\n* presumed\u002Fconfirmed diagnosis of syncope secondary to a non-dehydration cause (ex. arrhythmia, stroke, pulmonary embolism, sepsis, valvular heart disease)\n* inability to lay flat for the test\n* body weight greater than 350 lbs\n* inability to fit measurement devices around the participant wrist\n* abnormal bodily fluid retention (lymphedema, ascites, pleural effusions, peripheral edema)\n* neuromotor disorders\n* current congestive heart failure exacerbation or heart attack\u002Fmyocardial infarction\n* any implantable electronic devices\n* skin on limbs in poor condition (excessively, dry or rough or abrasions or wounds that would preclude application of electrode adhesive)","ALL","55 Years",{"count":20,"type":21},150,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","Dehydration among older adults a costs billions of dollars in US healthcare every year because no robust solution exists to detect changes in hydration and prevent negative outcomes. In this project, TritonX Technologies Inc. and academic research partners plan to test whether a newly created wearable sensor that measures hydration in real time can promote hydration and prevent the dehydration illnesses.\n\nThe investigators will conduct a randomized controlled trial to examine the effectiveness of continuous home monitoring of fluid levels in a cohort of vulnerable older adult patients seen in the emergency care setting.\n\nThe goal of this randomized control trial is to examine the effectiveness of continuous home monitoring of fluid levels in older patients presenting to the emergency department for dehydration. The main questions it aims to answer:\n\n1. Can a wearable device accurately determine the severity of dehydration at home and\n2. can a wearable device and continuous feedback from the device change behavior in the outpatient setting that can lead to improved outcomes in the treatment of dehydration in the elderly?\n\nInvestigators will compare device readings, hydration diaries, vital signs, blood samples, return visits to the emergency department, and to see if feedback from the device decreases signs and symptoms of dehydration and changes home management of dehydration.\n\nParticipants will be asked to:\n\n* wear the device and monitor hydration status\n* record the amount of home hydration\n* return in 7-10 days for reassessment of dehydration\n\nThe successful outcome of this study will include evidence for the effectiveness of the home, wearable hydration monitoring device, data necessary for the FDA 510(k) and related regulatory processes and substantial enhancements to both our knowledge of older adult needs and device functionality.",[27,28],"Dehydration","Syncope and Collapse",[30,31,32,33],"dehydration","total body water","bioimpedence","emergency department","NOT_YET_RECRUITING","2025-03-10",{"date":37,"type":38},"2025-03-13","ACTUAL",{"date":40,"type":21},"2025-04-01",{"date":42,"type":21},"2026-12-31",{"name":44,"class":45},"MetroHealth Medical Center","OTHER"]