[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"hypoactive-delirium\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:hypoactive-delirium":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,41],{"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":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"100319420","phase-4-the-basel-bomp-aid-randomized-trial-100319420",false,"NCT03438526","The Basel BOMP-AID Randomized Trial","Better Outcome With Melatonin Compared to Placebo Administered to Normalize Sleep-wake Cycle and Treat Hypoactive ICU Delirium The Basel BOMP-AID Randomized Trial","BOMP-AID","Inclusion Criteria:\n\nParticipants fulfilling all of the following inclusion criteria are eligible for the study:\n\n* Adult patients (aged 55 years or older)\n* Current delirium (hypoactive type) detected by a specialised assessment method: ICDSC score \\>2 and RASS score \\\u003C 0\n\nExclusion Criteria:\n\nParticipants meeting the following criteria are excluded from the study:\n\n* Delirium prior to ICU admission\n* Sleep disorder not caused by hypoactive delirium\n* Sedation in the ICU\n* Hypersensitivity to the studied substances (i.e., melatonin, placebo content)\n* Age \\\u003C55 years\n* Terminal state\n* Status epilepticus or postictal states following seizures on electroencephalogram (EEG)\n* Active psychosis\n* Substance abuse in current medical history\n* Dementia\n* Pregnancy","ALL","55 Years",{"count":20,"type":21},190,"ESTIMATED","INTERVENTIONAL",[24],"PHASE4","Delirium is a neurobehavioural syndrome that frequently develops in the postoperative and\u002For ICU setting. The incidence of elderly patients who develop delirium during hospital stay ranges from 11-82%. Delirium was first described more than half a century ago in the cardiac surgery population, where it was already discovered as a state that might be accompanied by serious complications such as prolonged ICU and hospital stay, reduced quality of life and increased mortality. Furthermore, the duration of delirium is associated with worse long-term cognitive function in the general ICU population. This long-term experience with delirium suggests a high socioeconomic liability and has been a focus of many studies. The aforementioned consequences of delirium are observed in all of three subtypes: hypoactive, hyperactive, and mixed. Pharmacological treatment options for hypoactive delirium are lacking. Since patients in hypoactive delirium suffer from disturbed circadian rhythm, the investigators suggest that the administration of melatonin as a promising possibility in these patients to shorten delirium duration and to lower its severity. Previous investigations confirmed loss of melatonin rhythm in patients that had developed delirium thus reasoning the study hypothesis.\n\nIn this randomized study, the investigators aim to test the hypothesis that the reinstitution of a normal circadian rhythm by the administration of melatonin compared to placebo after diagnosis of hypoactive delirium, decreases the duration of delirium and reduces the transmission to a form of agitated delirium. The administration might have to be repeated several times to achieve resolution of delirium.",[27],"Hypoactive Delirium","RECRUITING","2026-06-10",{"date":31,"type":32},"2026-06-11","ACTUAL",{"date":34,"type":32},"2022-01-03",{"date":36,"type":21},"2027-12",{"name":38,"class":39},"University Hospital, Basel, Switzerland","OTHER",1,{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":45,"acronym":4,"eligibilityCriteria":46,"healthyVolunteers":11,"sex":17,"minAge":47,"maxAge":4,"enrollmentInfo":48,"targetDuration":4,"studyType":50,"phases":4,"briefSummary":51,"conditions":52,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":53,"lastUpdatePostDateStruct":54,"startDateStruct":56,"completionDateStruct":58,"leadSponsor":60,"locationsCount":40},"100503575","a-comparison-of-healthcare-provider-and-caregiver-perception-of-discomfort-in-advanced-cancer-patients-who-have-a-hypoactive-delirium-100503575","NCT05837039","A Comparison of Healthcare Provider and Caregiver Perception of Discomfort in Advanced Cancer Patients Who Have a Hypoactive Delirium","Patient Inclusion Criteria:\n\n1. Patients with advanced cancer. Advanced cancer is defined as locally invasive, metastatic or recurrent cancer. Hematologic malignancies will also be included.\n2. Patients who are admitted to the acute palliative care unit (APCU) at MD Anderson Cancer Center.\n3. Patients who are unable to respond to questioning in the past 24 hours as determined by the attending physician, fellow physicians, or nursing staff of the APCU.\n4. Patients who are considered to be actively dying, as defined as likely to die during the admission and not regain consciousness. The physical exam findings that will be utilized to help define those patients who are actively dying may include one but not limited to one of the following symptoms: pulseless of the radial artery, Cheyne-stokes breathing, peripheral cyanosis, apnea periods, respiration with mandibular movement, turbulent airway noise produced on inspiration and\u002For expiration due to airway secretions commonly known as the \"death rattle\", and loss of nasolabial folds The presence of these signs will be based on the reporting of the attending physician, fellow physicians or nursing staff of the APCU.\n5. Patients who have an unpaid adult caregiver at bedside age 18 years or older, who is willing and able to provide informed consent and who has been present at bedside for at least 3 hours a day.\n\nPatient Exclusion Criteria:\n\n1. Patients who had a hyperactive or mixed delirium in which they either had high level of arousal due to delirium or had mixed episodes of arousal and agitation with periods of unresponsiveness.\n2. A family member or caregiver who cannot provide informed consent, or who cannot speak and read English.\n\nCaregiver Inclusion Criteria:\n\n1\\. Unpaid adult caregiver at bedside age 18 years or older, who is willing and able to provide informed consent, able to speak and read English, and who has been present at bedside for at least 3 hours a day.\n\nNursing Provider Inclusion Criteria:\n\n1\\. Nursing providers in the acute palliative care unit who are providing direct patient care to eligible patients.","18 Years",{"count":49,"type":21},100,"OBSERVATIONAL","To learn about your feelings as a caregiver about the level of discomfort of patients who have hypoactive delirium (loss of contact and response to reality) and who are at the end of life",[27],"2026-03-02",{"date":55,"type":32},"2026-03-04",{"date":57,"type":32},"2024-03-25",{"date":59,"type":21},"2027-12-31",{"name":61,"class":39},"M.D. Anderson Cancer Center"]