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

Not Applicable

Not yet recruiting

• Conditions: Delirium

• Registration Number: NCT07137949
• Lead Sponsor: Boston Medical Center

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-08
• Study First Submitted: 2025-08-15
• Study First Submitted QC: 2025-08-15
• Last Update Submitted: 2025-08-15
• Study First Posted: 2025-08-22
• Last Update Posted: 2025-08-22
• Study Start: 2025-10-01
• Primary Completion: 2026-10
• Study Completion: 2026-10-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Delirium scores	every 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 completed	during hospitalization, on average 7 days

Secondary Outcome Measures

Name	Time	Method
Number of days that participants screen CAM-positive	during hospitalization, on average 7 days	The 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 medications	during hospitalization, on average 7 days	Based on data from the electronic medical record.
Number of participants requiring physical restraints	during hospitalization, on average 7 days	Based on data from the electronic medical record.
Number of participants with one-to-one sitter orders	during hospitalization, on average 7 days	Based on data from the electronic medical record.

Trial Locations

Locations (1)

Boston Medical Center; 🇺🇸 Boston, Massachusetts, United States