NCT07137949 Delirium in Neurodegenerative Disease Patients: A Music Therapy Intervention for Hospital Care
| NCT ID | NCT07137949 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Boston Medical Center |
| Condition | Delirium |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2026-03-11 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 30 participants in total. It began in 2026-03-11 with a primary completion date of 2026-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 Alzheimer's disease and Parkinson's disease. Each 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.
Eligibility Criteria
Inclusion Criteria: * 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 Criteria: * 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
Contact & Investigator
Kara M Smith, MD MSCI FAAN
PRINCIPAL INVESTIGATOR
Boston Medical Center, Neurology
Frequently Asked Questions
Who can join the NCT07137949 clinical trial?
This trial is open to participants of all sexes, aged 60 Years or older, studying Delirium. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07137949 currently recruiting?
Yes, NCT07137949 is actively recruiting participants. Contact the research team at kara.smith@bmc.org for enrollment information.
Where is the NCT07137949 trial being conducted?
This trial is being conducted at Boston, United States.
Who is sponsoring the NCT07137949 clinical trial?
NCT07137949 is sponsored by Boston Medical Center. The principal investigator is Kara M Smith, MD MSCI FAAN at Boston Medical Center, Neurology. The trial plans to enroll 30 participants.