Music-Based Interventions, Aging, Alzheimer's Disease

Anxiety Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06152211
• Other study ID #: APP-23-05720
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 1, 2024
• Est. completion date: December 30, 2025

Study information

• Verified date: November 2023
• Source: University of Southern California
• Contact: Assal Habibi, PhD
• Phone: 2137403588
• Email: ahabibi[@]usc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 66
• Est. completion date: December 30, 2025
• Est. primary completion date: December 30, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 65 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Alzheimer Disease
• Anxiety
• Social Behavior
• Speech Perception

Intervention

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.
• Group Music Listening
A weekly collective music listening, 2 hours each for 16 weeks.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Southern California

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Anxiety as measured by State Trait Anxiety Inventory for Adults	anxiety symptoms	16 weeks
Other	Auditory Encoding as measured by auditory evoked potentials N1, P2 and P3 (EEG)	Strength of encoding auditory stimulus	16 weeks
Primary	Speech in Noise Perception ( SIN) as measured by QuickSIN	The ability to understand speech in noisy environments	16 weeks
Secondary	Self-Efficacy as measured by NIH Toolbox Self-Efficacy Short Form	Belief in one's capacity to have control over life events	16 weeks
Secondary	Interest in Life as measured by Apathy Short Form measure from NIH Toolbox	Interest and engagement in life	16 weeks
Secondary	Loneliness as measured by NIH Toolbox Loneliness Short Form	The degree to which a person is socially isolated from others	16 weeks