Clinical trial NCT06940687: Neurophysiological Benefits of Live Music for Early Alzheimer's Patients and Their Caregivers
Official title: Neurophysiological Benefits of Live Music for Early Alzheimer's Patients and Their Caregivers
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Alzheimer Disease
Dementia
Mild Cognitive Impairment
Peer-bonded Caregiver
Caregiver
Keywords: Live Music
EEG
EKG/ECG
Anxiety
Connectedness
Social Connection
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: Renée Fleming Foundation
name: Yale University School of Medicine, Department of Psychiatry
name: Howard University
name: NeuroArts Blueprint Initiative
First posted: 2025-04-23
Enrollment: 60
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Investigators aim to enroll 30 early Alzheimer's (AD) / Dementia / Mild Cognitive Impairment (MCI) participants and their 30 caregivers (30 dyads). A target sample size of 60 participants is proposed with an upper limit of 120 participants enrolled to allow for the possibility of losing a portion of the sample to follow-up.
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study aims to investigate the neurophysiological effects of live music on individuals with early Alzheimer's Disease (AD), dementia, and/or mild cognitive impairment (MCI) and their caregivers. Heart rate (HR), heart rate variability (HRV), and brain activity will be measured as participant-caregiver dyads listen to preferred and improvised music performed by professional musicians. Investigators will leverage various measurement techniques including, but not limited to, electroencephalography (EEG), behavioral, surveys, and physiological monitoring to study the impact of live music on anxiety in AD and inter-dyad synchrony.

Detailed description: Analysis of recordings captured during live concerts will be conducted using music information retrieval, pulse clarity, psychological ethnography, and similar methods. Investigators hypothesize that live music will reduce anxiety, increase social motivation, elevate parasympathetic activity, and enhance neural synchrony yielding increased interpersonal coordination, harmony, and emotional connection within dyads, indicating a positive impact on their autonomic nervous system and emotional well-being.

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.

Eligibility criteria: Inclusion Criteria:

* Clinical Dementia Rating 0.5 - 2
* 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:

* Clinical Dementia Rating \<0.5 or \> 2
* 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

Primary outcomes:
measure: Change in EEG activity during live music vs pre-recorded music conditions
timeFrame: Day 1 and Day 2, an average of 1 week apart
measure: motion capture
timeFrame: Day 1 and Day 2, an average of 1 week apart
measure: facial action units
timeFrame: Day 1 and Day 2, an average of 1 week apart
measure: eye gaze
timeFrame: Day 1 and Day 2, an average of 1 week apart
measure: Changes in Standard Deviation of Normal-to-Normal (SDNN) Interval via electrocardiography (ECG, EKG).
timeFrame: Day 1 and Day 2, an average of 1 week apart
measure: Changes in Root Mean Square of Successive Differences (RMSSD) via electrocardiography (ECG, EKG).
timeFrame: Day 1 and Day 2, an average of 1 week apart
measure: Changes in Very low frequency (VLF) via electrocardiography (ECG, EKG).
timeFrame: Day 1 and Day 2, an average of 1 week apart
measure: Changes in the ratio of low frequency and high frequency (LF/HF) via electrocardiography (ECG, EKG).
timeFrame: Day 1 and Day 2, an average of 1 week apart
Secondary outcomes:
measure: music information retrieval (MIR) methods
timeFrame: Day 1 and Day 2, an average of 1 week apart
measure: Change in social connection using State Motivation to Foster Social Connections (SMFSCS)Scale
timeFrame: Day 1 and Day 2, an average of 1 week apart
measure: Change in absorption in music using the Absorption in Music Scale (AIMS)
timeFrame: Day 1 and Day 2, an average of 1 week apart
measure: Change in absorption in music using the Geriatric Anxiety Scale (GAS)
timeFrame: Day 1 and Day 2, an average of 1 week apart
measure: Change in absorption in music using the State-Trait Anxiety Inventory (STAI)
timeFrame: Day 1 and Day 2, an average of 1 week apart
measure: Change in absorption in music using the Patient Health Questionnaire-9 (PHQ-9)
timeFrame: Day 1 and Day 2, an average of 1 week apart
measure: Change in absorption in music using the Zarit Burden Interview (ZBI)
timeFrame: Day 1 and Day 2, an average of 1 week apart
measure: Change in absorption in music using the Quality of Life Scale (QOLS)
timeFrame: Day 1 and Day 2, an average of 1 week apart
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Firehouse 12 Studios
state: Connecticut
city: New Haven
country: United States
facility: Musical Intervention Studios
state: Connecticut
Study officials:
affiliation: Yale University
name: AZA Allsop, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: