AzTrials
AzTrials

Alzheimer DiseaseNCT06940687

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

A study testing Pre-recorded Music Session and Live Music Session in people with Alzheimer Disease and Dementia, run by Yale University at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 50 to 80 years
What is being tested?
Pre-recorded Music Session and Live Music Session
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10 participants
Where
2 sitesUnited States
Study dates
28 Jan 2025to 27 Aug 2026
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • Firehouse 12 Studios

    New Haven, Connecticut, 06510

  • Musical Intervention Studios

    New Haven, Connecticut, 06520

Other trials in United States

About this study

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.

Read the 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.

Being tested
Pre-recorded Music Session, Live Music Session
Keywords
Live Music, EEG, EKG/ECG, Anxiety, Connectedness, Social Connection
Medical subject headings
Alzheimer Disease, Dementia, Cognitive Dysfunction, Anxiety Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Pre-recorded Music SessionBehavioural

    A pre-recorded concert session

  • Live Music SessionBehavioural

    A 45-minute live music performance

Study groups in NCT06940687
Study groupRoleWhat they receive
AD / Dementia / MCI participants and caregivers dyads with musicExperimentalEach 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.
Receives: Behavioral: Pre-recorded Music Session; Behavioral: Live Music Session

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in EEG activity during live music vs pre-recorded music conditions

    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

    Measured: Day 1 and Day 2, an average of 1 week apart

  2. motion capture

    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.

    Measured: Day 1 and Day 2, an average of 1 week apart

  3. facial action units

    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.

    Measured: Day 1 and Day 2, an average of 1 week apart

  4. eye gaze

    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.

    Measured: Day 1 and Day 2, an average of 1 week apart

  5. Changes in Standard Deviation of Normal-to-Normal (SDNN) Interval via electrocardiography (ECG, EKG).

    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.

    Measured: Day 1 and Day 2, an average of 1 week apart

  6. Changes in Root Mean Square of Successive Differences (RMSSD) via electrocardiography (ECG, EKG).

    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.

    Measured: Day 1 and Day 2, an average of 1 week apart

  7. Changes in Very low frequency (VLF) via electrocardiography (ECG, EKG).

    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.

    Measured: Day 1 and Day 2, an average of 1 week apart

  8. Changes in the ratio of low frequency and high frequency (LF/HF) via electrocardiography (ECG, EKG).

    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.

    Measured: Day 1 and Day 2, an average of 1 week apart

Secondary outcomes (8)

  1. music information retrieval (MIR) methods

    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.

    Measured: Day 1 and Day 2, an average of 1 week apart

  2. Change in social connection using State Motivation to Foster Social Connections (SMFSCS)Scale

    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.

    Measured: Day 1 and Day 2, an average of 1 week apart

  3. Change in absorption in music using the Absorption in Music Scale (AIMS)

    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.

    Measured: Day 1 and Day 2, an average of 1 week apart

  4. Change in absorption in music using the Geriatric Anxiety Scale (GAS)

    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.

    Measured: Day 1 and Day 2, an average of 1 week apart

  5. Change in absorption in music using the State-Trait Anxiety Inventory (STAI)

    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.

    Measured: Day 1 and Day 2, an average of 1 week apart

  6. Change in absorption in music using the Patient Health Questionnaire-9 (PHQ-9)

    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.

    Measured: Day 1 and Day 2, an average of 1 week apart

  7. Change in absorption in music using the Zarit Burden Interview (ZBI)

    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.

    Measured: Day 1 and Day 2, an average of 1 week apart

  8. Change in absorption in music using the Quality of Life Scale (QOLS)

    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.

    Measured: Day 1 and Day 2, an average of 1 week apart

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Apr 2025
  2. Study start28 Jan 2025
  3. Primary completion27 Aug 2026
  4. Study completion27 Aug 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Single group
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.
Masking
None (open label)
Enrolment
10 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06940687
Sponsor's protocol ID
2000038702
Other IDs
4U24AT012601-03
Status last verified
Oct 2026
First submitted
19 Feb 2025
Last updated
19 Oct 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Pre-recorded Music Session and Live Music Session in people with Alzheimer Disease and Dementia, run by Yale University at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in EEG activity during live music vs pre-recorded music conditions (time frame: Day 1 and Day 2, an average of 1 week apart). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06940687.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in