Neurophysiological Benefits of Live Music for Early Alzheimer's Patients and Their Caregivers
NCT ID: NCT06940687
Last Updated: 2025-04-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
60 participants
INTERVENTIONAL
2025-01-28
2025-08-31
Brief Summary
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Detailed Description
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The primary objective of this study is to investigate the neurophysiological effects of live music concert experiences on people living with early AD and their caregivers using EEG and HR monitoring.
The secondary objectives of this study are to:
* Understand whether the live concert experience reduces state anxiety and enhances connection between individuals with early AD and their caregivers.
* Determine what role the physical characteristics of the concert music have on the wellbeing, behavior, connectedness, and autonomic function of people with early AD and their caregivers.
In-person sessions of the study will be conducted at a music / event venue in either the Greater New Haven, CT area, with possible expansion to venue(s) in the Washington, DC area, and/or the Nashville, TN area. The Yale IRB-approved study team may conduct the study at additional locations (including in the Washington, DC area and the Nashville, TN area) with permission from the venue(s).
Each participant will take part in two sessions. Both sessions will last up to 3 hours.
Participants will attend a series of live music performances and pre-recorded control session performances. Physiological and survey data will be collected to assess the impact of live versus pre-recorded music on anxiety, social motivation, parasympathetic activity, and neural synchrony.
Conditions
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Study Design
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NA
SINGLE_GROUP
SUPPORTIVE_CARE
NONE
Study Groups
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AD / Dementia / MCI participants and caregivers dyads with music
Each participant will take part in two sessions. Both sessions will last up to 3 hours.
Participants will attend a series of live music performances and pre-recorded control session performances. Physiological and survey data will be collected to assess the impact of live versus pre-recorded music on anxiety, social motivation, parasympathetic activity, and neural synchrony.
Pre-recorded Music Session
A pre-recorded concert session
Live Music Session
A 45-minute live music performance
Interventions
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Pre-recorded Music Session
A pre-recorded concert session
Live Music Session
A 45-minute live music performance
Eligibility Criteria
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Inclusion Criteria
* Be a person with or caregiver to a person with a diagnosis of early Alzheimer's Disease, mild dementia, and/or mild cognitive impairment (MCI)
* Able to provide informed consent
* Willing to wear an EEG headset and heart rate monitoring devices
* Willing to possibly have small patches of body / facial hair shaved to accommodate administration of heart rate monitoring devices
* Willing to answer survey questions about topics related to the study
* Willing to be audio / video recorded
Exclusion Criteria
* Unable to provide informed consent
* Endorsing suicidal ideation (SI), self-injurious behavior, or homicidal ideation (HI) above the threshold defined in the "Risk Reduction and Safety Plan"
* Participating in another clinical trial studying AD and/or Dementia
* Starting a new prescription medication in the last 6 months
* Prescribed Benzodiazepines on an as needed basis
50 Years
80 Years
ALL
No
Sponsors
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Renée Fleming Foundation
UNKNOWN
Yale University School of Medicine, Department of Psychiatry
UNKNOWN
Howard University
OTHER
NeuroArts Blueprint Initiative
UNKNOWN
Yale University
OTHER
Responsible Party
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Principal Investigators
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AZA Allsop, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Yale University
Locations
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Firehouse 12 Studios
New Haven, Connecticut, United States
Musical Intervention Studios
New Haven, Connecticut, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2000038702
Identifier Type: -
Identifier Source: org_study_id
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