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

NCT07137949 | Recruiting

• 1 other identifier: H-46190
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Delirium

Keywords

Music therapy; Hospital acquired delirium; Neurodegenerative disease patients

Outcome Measures

Primary Outcomes (2)

• Delirium scores

  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.

  every 24 hours until discharge (on average 7 days)

• Number of music therapy sessions successfully completed

  Based on data from study records.

  during hospitalization, on average 7 days

Secondary Outcomes (4)

• Number of days that participants screen CAM-positive

  during hospitalization, on average 7 days

• Number of participants given antipsychotic medications

  during hospitalization, on average 7 days

• Number of participants requiring physical restraints

  during hospitalization, on average 7 days

• Number of participants with one-to-one sitter orders

  during hospitalization, on average 7 days

Study Arms (1)

Music therapy

EXPERIMENTAL

Participants will undergo one-on-one music therapy (MT) sessions of approximately 30 minutes duration conducted by a board-certified music therapist. Sessions will be customized to address patient needs but will consistently adhere to the four principal MT methods of re-creation, composition, improvisation, and therapeutic listening experiences.

Behavioral: Music therapy

Interventions

Music therapy BEHAVIORAL

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.

Music therapy

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Boston Medical Center: lead

Study Sites (1)

Boston Medical Center

Boston, Massachusetts, 02118, United States

RECRUITING

MeSH Terms

Conditions

Delirium

Interventions

Music Therapy

Condition Hierarchy (Ancestors)

Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Sensory Art Therapies; Complementary Therapies; Therapeutics; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Kara M Smith, MD MSCI FAAN

  Boston Medical Center, Neurology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kara M Smith, MD MSCI FAAN

CONTACT

617-638-5351; kara.smith@bmc.org

Amber Payne, MS

CONTACT

amber.payne@bmc.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 15, 2025
• First Posted: August 22, 2025
• Study Start: March 11, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: April 1, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)