Personalized music therapy to help prevent hospital delirium in people with Alzheimer’s, Parkinson’s, and related conditions.
Delirium in Neurodegenerative Disease Patients: A Music Therapy Intervention for Hospital Care
This pilot tests whether up to five personalized music therapy sessions can help prevent confusion (delirium) in hospitalized people with Alzheimer's, Parkinson's, or similar brain diseases.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 60 Years and up |
| Sex | All |
| Sponsor | Boston Medical Center Academic / other |
| Locations | 1 site (Boston, Massachusetts) |
| Trial ID | NCT07137949 on ClinicalTrials.gov |
What this trial studies
This pilot interventional program will enroll about 30 inpatients with neurodegenerative disease or documented cognitive impairment at Boston Medical Center. Each participant will receive up to five personalized music therapy sessions that may include live music, guided instrument play, or listening to recordings tailored to the individual. Study staff will collect surveys and feasibility metrics to learn how practical the intervention is in a hospital setting and how patients and caregivers perceive its helpfulness. Spanish-speaking participants are included with certified interpreter support, and legally authorized representatives may consent if participants cannot.
Who should consider this trial
Good fit: Ideal candidates are inpatients at Boston Medical Center with a diagnosis or documentation of Parkinson's disease, dementia with Lewy bodies, Alzheimer's-related dementias, vascular dementia, or other cognitive impairment, including Spanish speakers and those who require LAR consent.
Not a fit: Patients who are not hospitalized at Boston Medical Center, do not have neurodegenerative disease or cognitive impairment, or who have severe hearing loss or cannot participate in music sessions may not receive benefit from this intervention.
Why it matters
Potential benefit: If successful, the intervention could reduce episodes of hospital delirium and improve comfort and recovery for patients with neurodegenerative diseases.
How similar studies have performed: Previous smaller studies of music therapy in dementia and hospital settings have shown promising but mixed results, so personalized music approaches merit further testing in this specific patient group.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Boston, Massachusetts
- Boston Medical Center — Boston, Massachusetts, United States (Recruiting)
Study contacts
- Principal investigator: Kara M Smith, MD MSCI FAAN — Boston Medical Center, Neurology
- Study coordinator: Kara M Smith, MD MSCI FAAN
- Email: kara.smith@bmc.org
- Phone: 617-638-5351
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.