DeliriumDyNamicNCT07137949
Delirium in Neurodegenerative Disease Patients: A Music Therapy Intervention for Hospital Care
A study testing Music therapy in people with Delirium, run by Boston Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Delirium
- What is being tested?
- Music therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Mar 2026to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Amber Payne, MS contact
United States1 site, 1 recruiting
- Recruiting
Boston Medical Center
Boston, Massachusetts, 02118
Kara M Smith, MD MSCI FAAN, kara.smith@bmc.org
About this study
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
- Being tested
- Music therapy
- Keywords
- Music therapy, Hospital acquired delirium, Neurodegenerative disease patients
- Medical subject headings
- Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Music therapyBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Music therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: every 24 hours until discharge (on average 7 days)
Number of music therapy sessions successfully completed
Based on data from study records.
Measured: during hospitalization, on average 7 days
Secondary outcomes (4)
Number of days that participants screen CAM-positive
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).
Measured: during hospitalization, on average 7 days
Number of participants given antipsychotic medications
Based on data from the electronic medical record.
Measured: during hospitalization, on average 7 days
Number of participants requiring physical restraints
Based on data from the electronic medical record.
Measured: during hospitalization, on average 7 days
Number of participants with one-to-one sitter orders
Based on data from the electronic medical record.
Measured: during hospitalization, on average 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2025
- Study start11 Mar 2026
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DeliriumStudies of the same condition, open and under way.
- More trials run by Boston Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Boston Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kara M Smith, MD MSCI FAAN, Principal investigator, Boston Medical Center, Neurology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07137949
- Sponsor's protocol ID
- H-46190
- Acronym
- DyNamic
- Status last verified
- Mar 2026
- First submitted
- 15 Aug 2025
- Last updated
- 1 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Delirium in Neurodegenerative Disease Patients: A Music Therapy Intervention for Hospital Care
- ClinicalTrials.gov ID
- NCT07137949
- Acronym / sponsor ID
- DyNamic / H-46190
- Conditions
- Delirium
- Keywords
- Music therapy, Hospital acquired delirium, Neurodegenerative disease patients
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Boston Medical CenterUniversity, hospital or other
- Study start
- 11 Mar 2026 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 22 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Music therapy | Experimental | Behavioral: Music therapyParticipants 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. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Admitted as inpatient to Boston Medical Center.
- Cognitive impairment or neurodegenerative diseases as defined by either:
- 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.
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Music therapyLive 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. | Behavioural | Music therapy |
Primary outcome
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.
Number of music therapy sessions successfully completed
Time frame: during hospitalization, on average 7 days
Based on data from study records.
4 secondary outcomes
Number of days that participants screen CAM-positive
Time frame: during hospitalization, on average 7 days
Number of participants given antipsychotic medications
Time frame: during hospitalization, on average 7 days
Number of participants requiring physical restraints
Time frame: during hospitalization, on average 7 days
Number of participants with one-to-one sitter orders
Time frame: during hospitalization, on average 7 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Amber Payne, MS contact
Kara M Smith, MD MSCI FAAN principal investigator
Boston Medical Center, Neurology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Music therapy in people with Delirium, run by Boston Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kara M Smith, MD MSCI FAAN (617-638-5351, kara.smith@bmc.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Delirium scores (time frame: every 24 hours until discharge (on average 7 days)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2026.