An interventional study of Choir and Group Music Listening in Speech Perception, Anxiety and Social Behavior, sponsored by University of Southern California. Status unknown at 1 site in United States. Open to participants aged 65 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-08-02.
Sponsored by University of Southern California · Not applicable, Interventional, and Treatment
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.
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.
5,063 studies on the registry are indexed under Anxiety Disorders; 1,408 are open to participants now.
This study's planned enrollment of 66 is below the median of 80 across 4,339 interventional studies indexed under Anxiety Disorders.
Browse Anxiety Disorders studies →University of Southern California is the lead sponsor of 789 studies on the registry; 136 are open to participants now.
Of its 69 completed or terminated interventional studies of FDA-regulated products, 32 (46%) have results posted.
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Exclusion Criteria:
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
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 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
A weekly collective music listening, 2 hours each for 16 weeks.
Speech in Noise Perception ( SIN) as measured by QuickSIN
The ability to understand speech in noisy environments
Time frame: 16 weeks
Self-Efficacy as measured by NIH Toolbox Self-Efficacy Short Form
Belief in one's capacity to have control over life events
Time frame: 16 weeks
Interest in Life as measured by Apathy Short Form measure from NIH Toolbox
Interest and engagement in life
Time frame: 16 weeks
Loneliness as measured by NIH Toolbox Loneliness Short Form
The degree to which a person is socially isolated from others
Time frame: 16 weeks
Anxiety as measured by State Trait Anxiety Inventory for Adults
anxiety symptoms
Time frame: 16 weeks
Auditory Encoding as measured by auditory evoked potentials N1, P2 and P3 (EEG)
Strength of encoding auditory stimulus
Time frame: 16 weeks
Plan to share: Yes — 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.
Supporting information: Study protocol, Statistical analysis plan, 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
No publications or documents are linked to this record.
Start is estimated for Oct 2024; primary completion for Dec 2025, 14 months later.
Of 2,720 non-industry interventional studies with no phase under Anxiety Disorders, half reached primary completion within 13 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 31. This study's planned 14 months is close to that.
Counting every sponsor, half of 2,789 studies reached it within 12 months; a quarter within 5 and three quarters within 30.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Jul 2024. You cannot join it, but the record below documents what was studied.
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