Speech PerceptionNCT06152211
Music-Based Interventions, Aging, Alzheimer's Disease
A study testing Choir and Group Music Listening in people with Speech Perception and Anxiety, run by University of Southern California at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Speech Perception, Anxiety, Social Behavior
- What is being tested?
- Choir and Group Music Listening
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2024to 30 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Visual and Auditory Acuity: Adequate visual and auditory acuity, with correction if necessary.
- Language Proficiency: Fluency in English to ensure complete testing.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
University of Southern California
Los Angeles, California, 90089
Assal Habibi, 213-740-3588, ahabibi@usc.edu
About this study
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
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.
Read the 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.
- Conditions
- Speech Perception, Anxiety, Social Behavior
- Being tested
- Choir, Group Music Listening
- Keywords
- music, choir, aging, dementia, APOE ε4
- Medical subject headings
- Anxiety Disorders, Social Behavior, Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ChoirBehavioural
Also called Group Singing
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 ListeningBehavioural
A weekly collective music listening, 2 hours each for 16 weeks.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Group Music Listening |
What is being measured
The primary outcome is the main question the study is designed to answer.
Speech in Noise Perception ( SIN) as measured by QuickSIN
The ability to understand speech in noisy environments
Measured: 16 weeks
Secondary outcomes (3)
Self-Efficacy as measured by NIH Toolbox Self-Efficacy Short Form
Belief in one's capacity to have control over life events
Measured: 16 weeks
Interest in Life as measured by Apathy Short Form measure from NIH Toolbox
Interest and engagement in life
Measured: 16 weeks
Loneliness as measured by NIH Toolbox Loneliness Short Form
The degree to which a person is socially isolated from others
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2023
- Study start1 Oct 2024 (estimated)
- Primary completion30 Dec 2025 (estimated)
- Study completion30 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Speech PerceptionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Southern California
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Assal Habibi, University of Southern California
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06152211
- Sponsor's protocol ID
- APP-23-05720
- Status last verified
- Jul 2024
- First submitted
- 21 Nov 2023
- Last updated
- 2 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06152211
- Acronym / sponsor ID
- APP-23-05720
- Conditions
- Speech Perception, Anxiety, Social Behavior
- Keywords
- music, choir, aging, dementia, APOE ε4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- University of Southern CaliforniaUniversity, hospital or other
- Study start
- 1 Oct 2024 (estimated)
- Primary completion
- 30 Dec 2025 (estimated)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 30 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Choir | Experimental | Behavioral: ChoirFor 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. |
| Music Listening | Active comparator | Behavioral: Group Music ListeningOver 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. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- Visual and Auditory Acuity: Adequate visual and auditory acuity, with correction if necessary.
- Language Proficiency: Fluency in English to ensure complete testing.
Key exclusion criteria (6 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ChoirAlso: Group SingingA 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. | Behavioural | Choir |
| Group Music ListeningA weekly collective music listening, 2 hours each for 16 weeks. | Behavioural | Music Listening |
Primary outcome
Speech in Noise Perception ( SIN) as measured by QuickSIN
Time frame: 16 weeks
The ability to understand speech in noisy environments
3 secondary outcomes
Self-Efficacy as measured by NIH Toolbox Self-Efficacy Short Form
Time frame: 16 weeks
Interest in Life as measured by Apathy Short Form measure from NIH Toolbox
Time frame: 16 weeks
Loneliness as measured by NIH Toolbox Loneliness Short Form
Time frame: 16 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2024.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Choir and Group Music Listening in people with Speech Perception and Anxiety, run by University of Southern California at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Assal Habibi, PhD (2137403588, ahabibi@usc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Speech in Noise Perception ( SIN) as measured by QuickSIN (time frame: 16 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Aug 2024.