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Delirium in Neurodegenerative Disease Patients: A Music Therapy Intervention for Hospital Care

Delirium in Neurodegenerative Disease Patients: A Music Therapy Intervention for Hospital Care

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07137949
Acronym
DyNamic
Enrollment
30
Registered
2025-08-22
Start date
2026-03-11
Completion date
2026-12-01
Last updated
2026-04-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Delirium

Keywords

Music therapy, Hospital acquired delirium, Neurodegenerative disease patients

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.

Interventions

BEHAVIORALMusic therapy

Live music therapy (MT) sessions will occur 3 times/week, 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.

Sponsors

Boston Medical Center
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Delirium scoresevery 24 hours until discharge (on average 7 days)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.
Number of music therapy sessions successfully completedduring hospitalization, on average 7 daysBased on data from study records.

Secondary

MeasureTime frameDescription
Number of days that participants screen CAM-positiveduring hospitalization, on average 7 daysThe 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).
Number of participants given antipsychotic medicationsduring hospitalization, on average 7 daysBased on data from the electronic medical record.
Number of participants requiring physical restraintsduring hospitalization, on average 7 daysBased on data from the electronic medical record.
Number of participants with one-to-one sitter ordersduring hospitalization, on average 7 daysBased on data from the electronic medical record.

Countries

United States

Contacts

CONTACTKara M Smith, MD MSCI FAAN
kara.smith@bmc.org617-638-5351
CONTACTAmber Payne, MS
amber.payne@bmc.org
PRINCIPAL_INVESTIGATORKara M Smith, MD MSCI FAAN

Boston Medical Center, Neurology

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 2, 2026