Music-Based Interventions, Aging, Alzheimer's Disease

NCT06152211 | Recruiting

• 1 other identifier: APP-23-05720
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Speech Perception; Anxiety; Social Behavior

Keywords

music, choir, aging, dementia, APOE ε4

Outcome Measures

Primary Outcomes (1)

• Speech in Noise Perception ( SIN) as measured by QuickSIN

  The ability to understand speech in noisy environments

  16 weeks

Secondary Outcomes (3)

• Self-Efficacy as measured by NIH Toolbox Self-Efficacy Short Form

  16 weeks

• Interest in Life as measured by Apathy Short Form measure from NIH Toolbox

  16 weeks

• Loneliness as measured by NIH Toolbox Loneliness Short Form

  16 weeks

Other Outcomes (2)

• Anxiety as measured by State Trait Anxiety Inventory for Adults

  16 weeks

• Auditory Encoding as measured by auditory evoked potentials N1, P2 and P3 (EEG)

  16 weeks

Study Arms (2)

Choir

EXPERIMENTAL

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

Music Listening

ACTIVE COMPARATOR

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

Interventions

Choir BEHAVIORAL

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.

Also known as: Group Singing

Choir

Group Music Listening BEHAVIORAL

A weekly collective music listening, 2 hours each for 16 weeks.

Music Listening

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Southern California: lead

Study Sites (1)

University of Southern California

Los Angeles, California, 90089, United States

RECRUITING

MeSH Terms

Conditions

Anxiety Disorders; Social Behavior; Dementia

Condition Hierarchy (Ancestors)

Mental Disorders; Behavior; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders

Central Study Contacts

Assal Habibi, PhD

CONTACT

2137403588; ahabibi@usc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: 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.

Study Record Dates

• First Submitted: November 21, 2023
• First Posted: November 30, 2023
• Study Start: October 1, 2024
• Primary Completion: December 30, 2025
• Study Completion: December 30, 2025
• Last Updated: August 2, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• 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.
• 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

Locations

US (1)