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Behavioral Intervention

Music Therapy for Parkinson's Disease and Lewy Body Dementia

N/A

Waitlist Available

Research Sponsored by University of Massachusetts, Worcester

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Admitted as inpatient to UMass Memorial Medical Center University Campus

Diagnosis of PD or DLB (ICD-10 G20 and G31.83 respectively) on active problem list or past medical history OR carbidopa/levodopa on active medication list or ordered in admission orders.

Must not have

Patients in the intensive care unit receiving continuous intravenous sedative medication (as they would not be expected to be able to meaningfully participate in the study activities).

Admitted to observation status or to Clinical Decision Unit (as these patients would not be expected to remain inpatient long enough to undergo the MT intervention)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from enrollment up to 30 days after enrollment.

Summary

This trial is testing whether music therapy can prevent hospital-acquired delirium in patients with Parkinson's and Dementia with Lewy Bodies during hospitalization.

Who is the study for?

This trial is for inpatients at UMass Memorial Medical Center with Parkinson's Disease or Dementia with Lewy Bodies. Candidates must be able to hear and enjoy music, not have a history of music-induced seizures, and should not be sedated in intensive care or expected to leave the hospital within 24 hours.

What is being tested?

The study tests if music therapy can prevent confusion and memory problems (delirium) in patients hospitalized with Parkinson's or Lewy Body Dementia. Participants will receive either guided music therapy, listen to their own choice of music, or get standard care without added music intervention.

What are the potential side effects?

Music therapy is generally safe but may include discomfort from headphones/earbuds use during listening sessions. There are no significant side effects expected from this non-invasive intervention.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am currently an inpatient at UMass Memorial Medical Center University Campus.

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I have been diagnosed with Parkinson's Disease or Dementia with Lewy Bodies, or I am taking carbidopa/levodopa.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am not in the ICU on continuous IV sedation.

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I am admitted for a short hospital stay, not expected to stay long.

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I cannot hear sounds quieter than 71dB.

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I was admitted and discharged from the hospital within 24 hours.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from enrollment up to 30 days after enrollment.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from enrollment up to 30 days after enrollment.

This trial's timeline: 3 weeks for screening, Varies for treatment, and from enrollment up to 30 days after enrollment. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Confusion Assessment Measure (CAM)

Secondary study objectives

Medication Administration Records and Orders

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Placebo Group

Group I: Music TherapyExperimental Treatment1 Intervention

Music therapy intervention will be administered for 30 minutes 3 times per week between Day 0 and Day 15 of inpatient hospitalization. Daily passive music listening will be required for 30 minutes twice a day, at least 4 days per week. This daily listening experience will consist of personalized playlists developed by the music therapist with specific purpose and goal.

Group II: Active ControlActive Control1 Intervention

Daily passive music listening will be required for 30 minutes twice a day, at least 4 days per week. This daily listening experience will consist of non-personalized, auto-generated playlists based on popular genres. No interaction with a music therapist will occur.

Group III: Standard of carePlacebo Group1 Intervention

Usual standard of care.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Music therapy intervention

2023

N/A

~110

0 / 6Eligibility criteria met