Pre-recorded Music Session
BehavioralA pre-recorded concert session
NCT Number: NCT06940687
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.
Interested in participating?
Request Info50 year–80 year
All sexes
Interventional
Not applicable
Firehouse 12 Studios, New Haven, Connecticut, United States
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:
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
A pre-recorded concert session
A 45-minute live music performance
Time frame: Day 1 and Day 2, an average of 1 week apart
EEG gamma measured by the Post Spectral Density measures in the gamma range (>30Hz) and theta (4-8Hz) frequency ranges during live music vs pre-recorded music conditions
Time frame: Day 1 and Day 2, an average of 1 week apart
Capturing motion allows the researchers to investigate if patterns of bodily and stylistic characteristics of motion are associated with different emotional states in participants with Dementia and their caregivers. We will thematically analyze motion characteristics of and between individual participants during and between live and recorded music experiences using Laban Movement Analysis.
Time frame: Day 1 and Day 2, an average of 1 week apart
Capturing facial expressions (i.e. facial action units) allows the researchers to study behavioral differences in emotion and arousal of and between individual participants exhibited during and between live and recorded music experiences.
Time frame: Day 1 and Day 2, an average of 1 week apart
Capturing eye gaze allows the researchers to study behavioral differences in attention and arousal of and between individual participants exhibited during and between live and recorded music experiences.
Time frame: Day 1 and Day 2, an average of 1 week apart
Acquiring heart rate variability data via electrocardiography (ECG, EKG) allows the researchers to measure the standard deviation of Normal-to-Normal (SDNN) Interval in people with dementia, mild cognitive impairment, and/or Alzheimer's disease. SDNN Intervals measure both sympathetic and parasympathetic nervous system (SNS & PNS) responses (primarily sympathetic) in milliseconds.
Time frame: Day 1 and Day 2, an average of 1 week apart
Acquiring heart rate variability data via electrocardiography (ECG, EKG) allows the researchers to measure the Root Mean Square of Successive Differences (RMSSD) in people with dementia, mild cognitive impairment, and/or Alzheimer's disease. RMSSD measure parasympathetic responses in milliseconds.
Time frame: Day 1 and Day 2, an average of 1 week apart
Acquiring heart rate variability data via electrocardiography (ECG, EKG) allows the researchers to measure Very low frequency (VLF) in people with dementia, mild cognitive impairment, and/or Alzheimer's disease. VLF measure sympathetic responses in milliseconds squared.
Time frame: Day 1 and Day 2, an average of 1 week apart
Acquiring heart rate variability data via electrocardiography (ECG, EKG) allows the researchers to measure the ratio of low frequency (sympathetic response) and high frequency (parasympathetic response). This unitless measure is abbreviated as LF/HF and informs the researchers about the relationship between the SNS and PNS.
Time frame: Day 1 and Day 2, an average of 1 week apart
Analyzing the physical characteristics of the music played during the sessions via music information retrieval (MIR) methods help the researchers make inferences about what music is effective in modulating wellbeing, connectedness, and behavior in this population.
Time frame: Day 1 and Day 2, an average of 1 week apart
SMFSCS is a self-report questionnaire that measures the motivation individuals feel to form new connections and foster existing connection with others. 10 items on a 7-point Likert scale, from 1 (strongly disagree) to 7 (strongly agree). Total score is achieved by summing all items with total score range from 10-100. Higher scores indicate a greater motivation to create new connections and foster existing connections with others.
Time frame: Day 1 and Day 2, an average of 1 week apart
SMFSCS is a self-report questionnaire that measures an individual's tendency to have strong emotional responses to music. 35 items on a 5-point Likert scale, from 1 (strongly disagree) to 5 (strongly agree). Total score is achieved by summing all items with total score range from 35-175. Higher scores indicate a greater tendency to have strong emotional responses to music.
Time frame: Day 1 and Day 2, an average of 1 week apart
GAS is a self-report questionnaire that serves as a measure of anxiety for use with older adults. 30 items on a 5-point Likert scale, from 0 (not at all) to 3 (all of the time). Total score is achieved by summing items 1-25 with total score range from 0-75. Items 26 through 30 are used to help clinicians identify areas of concern for the respondent. Higher scores indicate more feelings of anxiety or stress.
Time frame: Day 1 and Day 2, an average of 1 week apart
STAI is a self-report questionnaire that measures transient and enduring levels of anxiety. 20 items on a 5-point Likert scale, from 1 (not at all) to 4 (very much so). Ten items are formed to record the presence of anxiety symptoms and the other 10 items are scored to record the absence of anxiety symptoms. Total score is achieved by summing all presence of anxiety items and inverting the absence of anxiety items with total score range from 20-80. Higher scores indicate higher levels transient and enduring anxiety.
Time frame: Day 1 and Day 2, an average of 1 week apart
PHQ-9 is a self-report questionnaire that assesses 8 DSM-IV diagnoses, divided into threshold disorders and subthreshold disorders. 9 items on a 4-point Likert scale, from 0 (not at all) to 3 (nearly everyday). An item was also added to the end of the diagnostic portion of the PHQ-9 asking patients who checked off any problems on the questionnaire how difficult these symptoms make the respondent's life. Total score is achieved by summing all items with total score range from 0-27. Higher scores indicate higher depression severity.
Time frame: Day 1 and Day 2, an average of 1 week apart
ZBI is a self-report questionnaire that measures the level of burden experienced by caregivers of patients with dementia. 22 items on a 5-point Likert scale, from 0 (never) to 4 (nearly always). Total score is achieved by summing all items with total score range from 0-88. Higher scores indicate greater burden.
Time frame: Day 1 and Day 2, an average of 1 week apart
QOLS is a self-report questionnaire that measures 5 conceptual domains of quality of life: material and physical well-being, relationships with other people, social, community and civic activities, personal development and fulfillment, and recreation. 16 items on a 7-point Likert scale, from 1 (terrible) to 7 (delighted). Total score is achieved by summing all items with total score range from 16-112. Higher scores indicate a greater satisfaction with life.
Yale University
Other
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