[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07137949":3,"trial-entities:NCT07137949":106,"trial-summary:NCT07137949":114},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":6,"overall_status":7,"completion_date":8,"status_verified_date":9,"last_update_date":10,"start_date":11,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":15,"detailed_description":16,"conditions":17,"keywords":19,"study_type":23,"primary_purpose":24,"phases":25,"enrollment_info":27,"interventions":30,"primary_outcomes":35,"secondary_outcomes":44,"sex":55,"minimum_age":56,"maximum_age":16,"healthy_volunteers":14,"eligibility_criteria":57,"std_ages":77,"locations":80,"central_contacts":94,"overall_officials":100,"references":104,"see_also_links":105},"NCT07137949","H-46190","Delirium in Neurodegenerative Disease Patients: A Music Therapy Intervention for Hospital Care","RECRUITING","2026-12","2026-03","2026-04-01","2026-03-11","Boston Medical Center","OTHER",false,"In this pilot study a new kind of music therapy will be created and tested to help prevent confusion, called delirium, that can happen in the hospital. This can affect people with brain diseases like Alzheimer's disease and Parkinson's disease.\n\nEach of the anticipated 30 participants will have up to five music therapy sessions. The sessions will be made just for them and may include live music, playing instruments, or listening to recorded music. Surveys will be used to learn how easy the therapy is to do in the hospital and what people think about how helpful the sessions may be for future patients.",null,[18],"Delirium",[20,21,22],"Music therapy","Hospital acquired delirium","Neurodegenerative disease patients","INTERVENTIONAL","TREATMENT",[26],"NA",{"count":28,"type":29},30,"ESTIMATED",[31],{"type":32,"name":20,"description":33,"armGroupLabels":34},"BEHAVIORAL","Live music therapy (MT) sessions will occur 3 times\u002Fweek, up to 5 sessions. Sessions will be responsive to patient preferences, culture, and identity using information gained from medical record review, intake assessment, and in the moment therapeutic assessments.",[20],[36,40],{"measure":37,"description":38,"timeFrame":39},"Delirium scores","The 3-Minute Diagnostic Interview for the Confusion Assessment Method (3D-CAM) will be used to assess presence and severity of delirium. For participants who cannot complete the 3D-CAM due to non-verbal status, the CAM-ICU will be used in its place.","every 24 hours until discharge (on average 7 days)",{"measure":41,"description":42,"timeFrame":43},"Number of music therapy sessions successfully completed","Based on data from study records.","during hospitalization, on average 7 days",[45,48,51,53],{"measure":46,"description":47,"timeFrame":43},"Number of days that participants screen CAM-positive","The 3-Minute Diagnostic Interview for the Confusion Assessment Method (CAM) will be used to assess delirium. It will provide a binary outcome: delirium present (CAM positive) or absent (CAM negative).",{"measure":49,"description":50,"timeFrame":43},"Number of participants given antipsychotic medications","Based on data from the electronic medical record.",{"measure":52,"description":50,"timeFrame":43},"Number of participants requiring physical restraints",{"measure":54,"description":50,"timeFrame":43},"Number of participants with one-to-one sitter orders","ALL","60 Years",{"inclusion":58,"exclusion":67,"raw_text":76},[59,60,61,62,63,64,65,66],"Admitted as inpatient to Boston Medical Center.","Cognitive impairment or neurodegenerative diseases as defined by either:","Diagnosis of Parkinson's Disease, Dementia with Lewy Bodies (ICD-10 G20 and G31.83 respectively), Alzheimer's Disease-related dementias (ICD-10 6D80), vascular dementia (F01), or other cognitive impairment (R41) on active problem list or past medical history","\"Cognitive impairment\" on active problem list or past medical history","Documentation elsewhere in the electronic medical record (e.g. notes) of any of these conditions","Participants with cognitive impairment will be included. If unable to consent, legally authorized representative (LAR) based on HRP-013-SOP-LARs, Children, and Guardians will be contacted to consent.","Spanish speaking participants will be included. Screening and informed consent procedures will be conducted using a certified medical interpreter. All intervention sessions and study team interactions will be conducted using these interpreter services.","Patients admitted to an intensive care unit will be included as long as they are not receiving continuous intravenous sedative medications. Potential participants in the intensive care unit setting will be discussed with a PI\u002Fco-I to ensure participation is appropriate on a case-by-case basis. The PI\u002FCo-I will confirm with the treating physician that there are no reasons as to why the potential participant should not be enrolled in the study.",[68,69,70,71,72,73,74,75],"Admitted to observation status (as these patients would not be expected to remain inpatient long enough to undergo the MT intervention)","Patients who will be discharged within 24 hours of eligibility based on discussion with primary admitting team","Self-reported history of musicogenic seizures","Hearing loss: unable to hear a recorded sound \\\u003C70 decibels (dB)","Dislike of music: Barcelona Music Reward Questionnaire score of \\\u003C40","Patients who are currently prisoners","Patients in the intensive care unit receiving continuous intravenous sedative medication","Pregnant women","Inclusion Criteria:\n\n* Admitted as inpatient to Boston Medical Center.\n* Cognitive impairment or neurodegenerative diseases as defined by either:\n\n  * Diagnosis of Parkinson's Disease, Dementia with Lewy Bodies (ICD-10 G20 and G31.83 respectively), Alzheimer's Disease-related dementias (ICD-10 6D80), vascular dementia (F01), or other cognitive impairment (R41) on active problem list or past medical history\n  * \"Cognitive impairment\" on active problem list or past medical history\n  * Documentation elsewhere in the electronic medical record (e.g. notes) of any of these conditions\n* Participants with cognitive impairment will be included. If unable to consent, legally authorized representative (LAR) based on HRP-013-SOP-LARs, Children, and Guardians will be contacted to consent.\n* Spanish speaking participants will be included. Screening and informed consent procedures will be conducted using a certified medical interpreter. All intervention sessions and study team interactions will be conducted using these interpreter services.\n* Patients admitted to an intensive care unit will be included as long as they are not receiving continuous intravenous sedative medications. Potential participants in the intensive care unit setting will be discussed with a PI\u002Fco-I to ensure participation is appropriate on a case-by-case basis. The PI\u002FCo-I will confirm with the treating physician that there are no reasons as to why the potential participant should not be enrolled in the study.\n\nExclusion Criteria:\n\n* Admitted to observation status (as these patients would not be expected to remain inpatient long enough to undergo the MT intervention)\n* Patients who will be discharged within 24 hours of eligibility based on discussion with primary admitting team\n* Self-reported history of musicogenic seizures\n* Hearing loss: unable to hear a recorded sound \\\u003C70 decibels (dB)\n* Dislike of music: Barcelona Music Reward Questionnaire score of \\\u003C40\n* Patients who are currently prisoners\n* Patients in the intensive care unit receiving continuous intravenous sedative medication\n* Pregnant women",[78,79],"ADULT","OLDER_ADULT",[81],{"facility":12,"status":7,"city":82,"state":83,"zip":84,"country":85,"contacts":86,"geoPoint":91},"Boston","Massachusetts","02118","United States",[87],{"name":88,"role":89,"email":90},"Kara M Smith, MD MSCI FAAN","CONTACT","kara.smith@bmc.org",{"lat":92,"lon":93},42.35843,-71.05977,[95,97],{"name":88,"role":89,"phone":96,"email":90},"617-638-5351",{"name":98,"role":89,"email":99},"Amber Payne, MS","amber.payne@bmc.org",[101],{"name":88,"affiliation":102,"role":103},"Boston Medical Center, Neurology","PRINCIPAL_INVESTIGATOR",[],[],{"nct_id":4,"conditions":107,"biomarkers":113},[108,109,110,111,112],"Alzheimer's Disease","Cognitive Dysfunction","Lewy Body Dementia","Parkinson Disease","Vascular Dementia",[],{"nct_id":4,"found":115,"summary":116,"prompt_version":126},true,{"design":117,"status":118,"heading":119,"summary":120,"follow_up":121,"word_count":122,"commitments":123,"compensation":124,"drugs_mentioned":125},"This is an interventional study with a planned enrollment of 30 participants. It is a pilot study to create and test a new kind of music therapy.","completed","Music Therapy for Delirium in Neurodegenerative Disease Patients","This study is testing a new type of music therapy to help prevent delirium (confusion) in hospitalized patients with neurodegenerative diseases like Alzheimer's and Parkinson's. The music therapy sessions will be personalized for each patient, potentially including live music, playing instruments, or listening to recordings. Researchers want to see if this music therapy can reduce delirium scores and how many sessions patients can successfully complete. You might be able to join if you are 60 or older, admitted to Boston Medical Center, and have a diagnosis of a cognitive impairment or neurodegenerative disease. The study aims to enroll 30 participants, but its current recruitment status is unclear.","Delirium scores will be measured until discharge, which is on average 7 days. The number of music therapy sessions completed will also be tracked during hospitalization.",107,"You would participate in up to five live music therapy sessions, 3 times per week, during your hospitalization. Delirium scores will be measured every 24 hours until discharge.","Not stated in the trial record.",[20],"v2"]