NCT06940687

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

Enrolling by Invitation
NAAges 50–80InterventionalSupportive care
Yale University
~60 participants
Updated 2026-02-11 on ClinicalTrials.gov
What's tested:Pre-recorded Music SessionLive Music Session

At a glance

Recruiting sites
0 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in EEG activity during live music vs pre-recorded music conditions
Measured over Day 1 and Day 2, an average of 1 week apart
+7 more outcomes measured
Alzheimer Disease
Dementia
Mild Cognitive Impairment
Peer-bonded Caregiver
Caregiver
2 sites across 1 states
Connecticut2
  • AZA Allsop, MD, PhD · PRINCIPAL_INVESTIGATOR · Yale University

This trial hasn't published a contact. View it on ClinicalTrials.gov

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Eligibility criteria

Inclusion

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

Exclusion

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
  • Change in EEG activity during live music vs pre-recorded music conditionsDay 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

  • motion captureDay 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.

  • facial action unitsDay 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.

  • eye gazeDay 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.

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

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

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

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