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Enrolling By InvitationNCT06940687

Neurophysiological Benefits of Live Music for Early Alzheimer's Patients and Their Caregivers

Status
Enrolling By Invitation
Phase
N/A
Study type
Interventional
Enrollment
60 (estimated)
Sponsor
Yale University · Academic / Other
Sex
All
Age
50 Years – 80 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
BEHAVIORALPre-recorded Music SessionA pre-recorded concert session
BEHAVIORALLive Music SessionA 45-minute live music performance

Timeline

Start date
2025-01-28
Primary completion
2026-03-22
Completion
2026-03-22
First posted
2025-04-23
Last updated
2026-02-11

Locations

2 sites across 1 country: United States

Source: ClinicalTrials.gov record NCT06940687. Inclusion in this directory is not an endorsement.

Neurophysiological Benefits of Live Music for Early Alzheimer's Patients and Their Caregivers (NCT06940687) · Clinical Trials Directory