Trials / Enrolling By Invitation
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
| Type | Name | Description |
|---|---|---|
| BEHAVIORAL | Pre-recorded Music Session | A pre-recorded concert session |
| BEHAVIORAL | Live Music Session | A 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.