Personalized music therapy to help prevent hospital delirium in people with Alzheimer’s, Parkinson’s, and related conditions.

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.