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NCT Number: NCT07137949

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

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.

Recruiting

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Key information

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Boston Medical Center

Boston, Massachusetts, 02118, United States

Location status: Recruiting

Location contact

Kara M Smith, MD MSCI FAAN

CONTACT

[email protected]

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Delirium scores

    Time frame: 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.

  2. Number of music therapy sessions successfully completed

    Time frame: during hospitalization, on average 7 days

    Based on data from study records.

Secondary outcomes

  1. Number of days that participants screen CAM-positive

    Time frame: 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).

  2. Number of participants given antipsychotic medications

    Time frame: during hospitalization, on average 7 days

    Based on data from the electronic medical record.

  3. Number of participants requiring physical restraints

    Time frame: during hospitalization, on average 7 days

    Based on data from the electronic medical record.

  4. Number of participants with one-to-one sitter orders

    Time frame: during hospitalization, on average 7 days

    Based on data from the electronic medical record.

Study contacts

Contact information is provided by the study sponsor or research team.

Amber Payne, MS

CONTACT

[email protected]

Kara M Smith, MD MSCI FAAN

CONTACT

[email protected]

617-638-5351

Sponsors and collaborators

Lead sponsor

Boston Medical Center

Other

Registry information

Acronym: DyNamic

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Aug 22, 2025
Registry last updated
Apr 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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