Music-Based Interventions, Aging, Alzheimer's Disease

Using Music-Based Interventions to Improve the Quality of Life and Wellbeing of Older Adults With or at Risk of Alzheimer's Disease

Using a randomized controlled trial design, the investigators will examine the effects of music engagement through choir training on the hearing, communication, and psychosocial well-being of older adults, particularly those at heightened risk of developing dementia.

Study Overview

• Status: Recruiting
• Conditions: Anxiety; Social Behavior; Speech Perception
• Intervention / Treatment: Behavioral: Choir; Behavioral: Group Music Listening

Detailed Description

Major demographic transitions are underway in the developed world and adults aged 65 and over are the fastest growing segment of the United States population. Aging is associated with the deterioration of sensory and perceptual processes as well as a decline in cognitive functioning including attention and working memory. Advancing age is also associated with an increased risk of developing dementia including Alzheimer's disease (AD), a progressive neurodegenerative condition. The ε4 allele of APOE is one of three common alleles generated by cysteine/arginine substitutions. Although multiple genetic and environmental risk factors are involved in AD, the possession of the ɛ4 allele is recognized as the most common identifiable genetic risk factor for late-onset AD. The proportion of patients with AD that is attributable to the APOE ε4 is estimated to be 20% in people aged ≥ 55 years 5. Although the APOE 4 allele increases the risk of developing AD by three to fifteen times, recent studies have shown that the risk can be modified by non-genetic factors, including high education and leisure activities.

Another significant and related problem of aging is a decline in hearing abilities. Age-related hearing loss is a common problem for older adults, leading to communication difficulties, isolation, and cognitive decline. The difficulty understanding speech in noisy environments is one consequence of hearing loss that is particularly difficult to restore with hearing aids. Speech-in-noise (SIN) perception appears to be supported by both the efficiency of bottom-up sound encoding and the influence of higher-level top-down processes such as auditory working memory and selective attention. Decline in hearing and reduction in communication are associated with an increased rate of cognitive decline and the development of dementia in older adults. Decline in SIN perception can also make it difficult for aging individuals to engage socially and maintain relationships and has been linked to loneliness and depression. Indeed, poor SIN perception may contribute to cognitive decline and increased risk of dementia both through taxing cognitive load and decreasing social engagement. As a result, there is a critical need for effective and accessible interventions that target hearing, particularly interventions that are motivating and engaging and can be applied to the expanding population of older adults, especially those at higher risk of AD. The investigators will conduct an individually randomized group treatment trial to investigate the effects of choir training and its underlying neurobiological mechanisms on SIN perception and psychosocial well-being in adults ages 65 and older half carriers of APOE ε4 and the other half of non-carriers. The investigators will randomly assign approximately 66 older adults to a 16-week: (1) community choir program or (2) a group music listening program.

• Study Type: Interventional
• Enrollment (Estimated): 66
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Assal Habibi, PhD; Phone Number: 2137403588; Email: ahabibi@usc.edu

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90089
      • Recruiting
      • University of Southern California
      • Contact: Assal Habibi; Phone Number: 213-740-3588; Email: ahabibi@usc.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Visual and Auditory Acuity: Adequate visual and auditory acuity, with correction if necessary.
• Language Proficiency: Fluency in English to ensure complete testing.

Exclusion Criteria:

• Hearing Loss: Severe hearing loss not correctable with aids.
• Neurological and Otologic Conditions: History of known neurological or otologic conditions.
• Psychiatric Disorders: Current severe psychiatric disorders (past disorders not included).
• Medical Conditions: Unstable or serious medical conditions that could limit participation in assessments or weekly meetings.
• Cognitive Function: Impaired cognitive function, indicated by a score of less than 26 on the Montreal Cognitive Assessment (MoCA).
• Music Training: Current or past professional music training, defined as 3 years of regular, formal practice, excluding typical educational curriculum music classes or singing in worship services.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Choir; For each choir session, the choir director will be supported by an accompanist who will provide the music accompaniment for the songs and four section leaders who will provide musical leadership for choral sections (soprano, alto tenor & bass). At the beginning of each choir group, participants will be asked about their favorite songs to help ensure that the music will be appropriate for the participants' interest and cultural background. Each choir group will rehearse once a week for two hours with a short break in the middle for snacks for a total of 16 consecutive weeks. The choir rehearsals will follow a general routine, beginning with announcements and warm-ups, work on the repertoire, a break, additional work on the repertoire in sections, and a short group practice at the end. Participants will also be given at-home activities, in the form of pre-recorded videos and music theory exercises to complete outside of class for an estimated 1.5 hours per week.	Behavioral: Choir; A choir for older adults is a musical/singing ensemble composed of individuals aged 65 and above. The choir rehearsals are weekly, 2 hours each and the length of the intervention is 16 weeks total.; Other Names: Group Singing
Active Comparator: Music Listening; Over the course of 16-weeks, the group will meet for two hours per week to talk about a set of musical recordings. Recorded music will be previously assigned and provided as a playlist via a web platform to track the time duration of engagement. Regular attendance will be required. The discussion group will meet as a full group each week to listen to a subset of that week's recordings, with a guided and brief discussion after each of the six selected songs. The group will then pause for a brief break and will divide into four smaller discussion groups where a volunteer facilitator from that group would guide a discussion about the selected music, to include personal reflections, its cultural context, and ideas around societal impacts.	Behavioral: Group Music Listening; A weekly collective music listening, 2 hours each for 16 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Speech in Noise Perception ( SIN) as measured by QuickSIN	The ability to understand speech in noisy environments	16 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Self-Efficacy as measured by NIH Toolbox Self-Efficacy Short Form	Belief in one's capacity to have control over life events	16 weeks
Interest in Life as measured by Apathy Short Form measure from NIH Toolbox	Interest and engagement in life	16 weeks
Loneliness as measured by NIH Toolbox Loneliness Short Form	The degree to which a person is socially isolated from others	16 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Anxiety as measured by State Trait Anxiety Inventory for Adults	anxiety symptoms	16 weeks
Auditory Encoding as measured by auditory evoked potentials N1, P2 and P3 (EEG)	Strength of encoding auditory stimulus	16 weeks

Collaborators and Investigators

• Sponsor: University of Southern California

Study record dates

Study Major Dates

• Study Start (Estimated): October 1, 2024
• Primary Completion (Estimated): December 30, 2025
• Study Completion (Estimated): December 30, 2025

Study Registration Dates

• First Submitted: November 21, 2023
• First Submitted That Met QC Criteria: November 21, 2023
• First Posted (Actual): November 30, 2023

Study Record Updates

• Last Update Posted (Actual): August 2, 2024
• Last Update Submitted That Met QC Criteria: July 31, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Keywords: music, choir, aging, dementia, APOE ε4
• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Neurodegenerative Diseases; Dementia; Tauopathies; Alzheimer Disease
• Other Study ID Numbers: APP-23-05720

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All study protocols and analysis plans will be shared. Raw EEG data will be made available in its original format that can be accessed and imported to different analysis software. A supplement document with additional information about protocol design and relevant triggers and responses will also be provided in the data dictionary.
• IPD Sharing Time Frame: Following the NIH Data Sharing Policy and Implementation Guidelines, we plan to make the datasets available for sharing at the time that the main project findings are accepted for publication. That is, the raw data files and analysis scripts, which will initially be used for internal study team purposes, will be available for public use after our main intervention effects paper is published; within one year of the final year of funding.
• IPD Sharing Access Criteria: Individual researchers can contact the PIs for data and through filling out a data request and use form that we will create for the purposes of data sharing
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No