Status:
NOT_YET_RECRUITING
Delirium in Neurodegenerative Disease Patients: A Music Therapy Intervention for Hospital Care
Lead Sponsor:
Boston Medical Center
Conditions:
Delirium
Eligibility:
All Genders
60+ years
Phase:
NA
Brief Summary
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 ...
Eligibility Criteria
Inclusion
- 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/co-I to ensure participation is appropriate on a case-by-case basis. The PI/Co-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.
Exclusion
- 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 \<70 decibels (dB)
- Dislike of music: Barcelona Music Reward Questionnaire score of \<40
- Patients who are currently prisoners
- Patients in the intensive care unit receiving continuous intravenous sedative medication
- Pregnant women
Key Trial Info
Start Date :
February 1 2026
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2026
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT07137949
Start Date
February 1 2026
End Date
December 1 2026
Last Update
December 31 2025
Active Locations (1)
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1
Boston Medical Center
Boston, Massachusetts, United States, 02118