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

Обзор

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.

Подробное описание

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.

Вмешательства

• Поведенческое Pre-recorded Music Session
  A pre-recorded concert session
• Поведенческое Live Music Session
  A 45-minute live music performance

Первичные конечные точки

• Change in EEG activity during live music vs pre-recorded music conditions [Срок оценки: Day 1 and Day 2, an average of 1 week apart]
• motion capture [Срок оценки: Day 1 and Day 2, an average of 1 week apart]
• facial action units [Срок оценки: Day 1 and Day 2, an average of 1 week apart]
• eye gaze [Срок оценки: Day 1 and Day 2, an average of 1 week apart]
• Changes in Standard Deviation of Normal-to-Normal (SDNN) Interval via electrocardiography (ECG, EKG). [Срок оценки: Day 1 and Day 2, an average of 1 week apart]
• Changes in Root Mean Square of Successive Differences (RMSSD) via electrocardiography (ECG, EKG). [Срок оценки: Day 1 and Day 2, an average of 1 week apart]
• Changes in Very low frequency (VLF) via electrocardiography (ECG, EKG). [Срок оценки: Day 1 and Day 2, an average of 1 week apart]
• Changes in the ratio of low frequency and high frequency (LF/HF) via electrocardiography (ECG, EKG). [Срок оценки: Day 1 and Day 2, an average of 1 week apart]

Вторичные конечные точки (8)

• music information retrieval (MIR) methods [Срок оценки: Day 1 and Day 2, an average of 1 week apart]
• Change in social connection using State Motivation to Foster Social Connections (SMFSCS)Scale [Срок оценки: Day 1 and Day 2, an average of 1 week apart]
• Change in absorption in music using the Absorption in Music Scale (AIMS) [Срок оценки: Day 1 and Day 2, an average of 1 week apart]
• Change in absorption in music using the Geriatric Anxiety Scale (GAS) [Срок оценки: Day 1 and Day 2, an average of 1 week apart]
• Change in absorption in music using the State-Trait Anxiety Inventory (STAI) [Срок оценки: Day 1 and Day 2, an average of 1 week apart]
• Change in absorption in music using the Patient Health Questionnaire-9 (PHQ-9) [Срок оценки: Day 1 and Day 2, an average of 1 week apart]
• Change in absorption in music using the Zarit Burden Interview (ZBI) [Срок оценки: Day 1 and Day 2, an average of 1 week apart]
• Change in absorption in music using the Quality of Life Scale (QOLS) [Срок оценки: Day 1 and Day 2, an average of 1 week apart]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Поддерживающая терапия

Центры проведения

США · 2 центра

• Firehouse 12 Studios — New Haven
• Musical Intervention Studios — New Haven

Идентификаторы

NCT: NCT06940687 · 2000038702

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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