Music-Based Interventions, Aging, Alzheimer's Disease

Sponsor
University of Southern California (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06152211
Collaborator
(none)
66
2
24

Study Details

Study Description

Brief Summary

Using a randomized controlled trial design, we 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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Choir
  • Behavioral: Group Music Listening
N/A

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 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 AD4. 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. We 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. We will randomly assign approximately 66 older adults to a 16-week: (1) community choir program or (2) a group music listening program.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
66 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
An individually randomized group treatment trial where adults ages 65 and older half of carriers of APOE ε4 and the other half of non-carriers will be randomly assigned to a 16-week: (1) community choir program or (2) a group music listening program.An individually randomized group treatment trial where adults ages 65 and older half of carriers of APOE ε4 and the other half of non-carriers will be randomly assigned to a 16-week: (1) community choir program or (2) a group music listening program.
Masking:
Double (Investigator, Outcomes Assessor)
Masking Description:
Participants will be masked to the hypothesis of the study. Outcome assessors and investigators will be masked to the group randomization. Randomization will be stratified on gender, age (<77, ≥77), APOE ε4 carrier status, and hearing aid use. The randomization list will be prepared by an expert statistician outside of the study team.One one research coordinator will have access to the randomization allocation.
Primary Purpose:
Treatment
Official Title:
Using Music-Based Interventions to Improve the Quality of Life and Wellbeing of Older Adults With or at Risk of Alzheimer's Disease
Anticipated Study Start Date :
Jan 1, 2024
Anticipated Primary Completion Date :
Dec 30, 2025
Anticipated Study Completion Date :
Dec 30, 2025

Arms and Interventions

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.

    Outcome Measures

    Primary Outcome Measures

    1. Speech in Noise Perception ( SIN) as measured by QuickSIN [16 weeks]

      The ability to understand speech in noisy environments

    Secondary Outcome Measures

    1. Self-Efficacy as measured by NIH Toolbox Self-Efficacy Short Form [16 weeks]

      Belief in one's capacity to have control over life events

    2. Interest in Life as measured by Apathy Short Form measure from NIH Toolbox [16 weeks]

      Interest and engagement in life

    3. Loneliness as measured by NIH Toolbox Loneliness Short Form [16 weeks]

      The degree to which a person is socially isolated from others

    Other Outcome Measures

    1. Anxiety as measured by State Trait Anxiety Inventory for Adults [16 weeks]

      anxiety symptoms

    2. Auditory Encoding as measured by auditory evoked potentials N1, P2 and P3 (EEG) [16 weeks]

      Strength of encoding auditory stimulus

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    65 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    (1) Adequate visual and auditory acuity (with correction) and (2) Fluency in English to ensure complete testing.

    Exclusion Criteria:

    (1) severe hearing loss (2) history of known neurological condition, otologic condition, current (but not prior) severe psychiatric disorder, unstable or serious medical condition that may limit participation in the assessments or weekly meetings; (3) impaired cognitive function as indicated by score < 26 on the Montreal Cognitive Assessment (MoCA); (4) current or prior professional music training defined as 3 years of any regular and formal music practice, excluding music classes as part of typical education curriculum or singing at worship services

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • University of Southern California

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Assal Habibi, Associate Professor, University of Southern California
    ClinicalTrials.gov Identifier:
    NCT06152211
    Other Study ID Numbers:
    • APP-23-05720
    First Posted:
    Nov 30, 2023
    Last Update Posted:
    Nov 30, 2023
    Last Verified:
    Nov 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Assal Habibi, Associate Professor, University of Southern California
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Nov 30, 2023