Following the Sound of Music
14 de agosto de 2026 atualizado por: Susanne Jaeggi, Northeastern University
Comparing the Effects of Music vs. Non-Music Based Interventions on Auditory and Cognitive Processing in Older Adults
The proposed study will enroll healthy older adult participants to examine the effectiveness of music listening activities to promote hearing and cognition.
Participants will be randomized into one of four experimental groups and can expect to participate for up to 21 hours of research distributed over 20 weeks.
Visão geral do estudo
Status
Recrutamento
Condições
Tipo de estudo
Intervencional
Inscrição (Estimado)
216
Estágio
- Não aplicável
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Contato de estudo
- Nome: Audrey Carrillo, MA
- Número de telefone: 626-482-8091
- E-mail: a.carrillo@northeastern.edu
Locais de estudo
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Massachusetts
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Boston, Massachusetts, Estados Unidos, 02115
- Recrutamento
- Northeastern University
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Contato:
- Audrey Carrillo, MA
- Número de telefone: 626-482-8091
- E-mail: a.carrillo@northeastern.edu
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Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Sim
Descrição
Inclusion Criteria:
- Age: 60+
- No self-reported auditory difficulties and normal or near-normal hearing sensitivity as measured by SRTs.
- Should have no more than typical hearing loss for their age and no evidence of dementia.
- Fluent in English and/or Spanish
- No more than two years of formal music training in childhood OR in the past 20 years
Exclusion Criteria:
- Abnormal vision or hearing prohibitive of training
- History of seizures, focal brain lesion, or head injury with loss of consciousness
- Physical handicap (motor or perceptual) that would impede training procedures
- Social, educational or economic hardship prohibitive to training schedule Concurrent enrollment in other cognitive training studies
- History of major psychiatric illness, including psychosis, bipolar disorder, depression, alcohol or substance abuse, recent bereavement
- Geriatric Depression Scale-15 (GDS-15) score of 6 or higher, indicating clinically significant depressive symptoms
- Not being proficient enough in English or Spanish that would prevent following and understanding all instructions and completing all testing sessions
- Diagnosis of dementia or other neurological disease, including mild cognitive impairment (MCI)
- Telephone-Montreal Cognitive Assessment (t-MoCA) score of 16 or less
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Ciência básica
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Dobro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
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Experimental: Sound of Music Plus Attention
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Participants will listen to musical excerpts, and guided instructions will be provided to tell the participants what aspect of the music to pay attention to and how to respond.
Participants will log responses on an interactive tablet-based interface.
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Experimental: Sound of Music
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Participants will listen to musical excerpts and will be provided with guided instructions directing their attention to specific aspects of the music.
Participants will report when they perceive a noticeable change in the music (e.g., changes in instrumentation, rhythm, texture, or intensity).
Participants will log responses on an interactive tablet-based interface.
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Experimental: Sound of Tones Plus Attention
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Participants will be asked to attend to auditory stimuli and respond to them according to guided instructions.
Participants will log responses on an interactive tablet-based interface.
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Sem intervenção: Business as usual Control
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Digits-in-Noise Task
Prazo: Pre-test (week 1), Mid-test (week 5), Post-test (week 10), Follow-up (week 18)
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The Digits-in-Noise (DIN) test presents trials of three sequential spoken digits against a broad-band, speech-shaped masker.
Signal/noise ratio is varied adaptively to track 50% correct.
The dependent variable is the threshold noise tolerance in dB.
Lower scores indicate better performance.
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Pre-test (week 1), Mid-test (week 5), Post-test (week 10), Follow-up (week 18)
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Spatial Release From Masking Task
Prazo: Pre-test (week 1), Mid-test (week 5), Post-test (week 10), Follow-up (week 18)
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Tests the ability to distinguish speech from competing speech.
Collocated condition uses target and two competing maskers all located directly in front of the listener, and spatially separated condition uses two masking sentences sent from 45 degrees to the left and right of center.
Sentences are correctly identified as part of a series of test trials in which TMR progressively reduced every two trials.
The dependent variable is the threshold target-to-masker ratio (TMR) as estimated based on the number of sentences correctly identified.
Lower scores indicate better performance.
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Pre-test (week 1), Mid-test (week 5), Post-test (week 10), Follow-up (week 18)
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Dichotic Sentence Identification Task
Prazo: Pre-test (week 1), Mid-test (week 5), Post-test (week 10), Follow-up (week 18)
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The DSI test simultaneously presents two nonsense sentences, one to each ear.
Participants indicate two sentences heard from a list of alternatives.
DSI sentences are presented at a comfortable listening level, usually 50 dB above pure-tone average of each ear.
The dependent variable is the percentage of sentences correctly identified.
Higher scores indicate better performance.
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Pre-test (week 1), Mid-test (week 5), Post-test (week 10), Follow-up (week 18)
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Revised Hearing Handicap Inventory for the Elderly (RHHI)
Prazo: Pre-test (week 1), Post-test (week 10), Follow-up (week 18)
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Survey that assesses the perceived level of hearing ability under different environmental or social situations, and participants also self-report ear surgeries or known ear pathologies.
The dependent variable is total score (summed).
Higher scores indicate greater perceived handicap.
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Pre-test (week 1), Post-test (week 10), Follow-up (week 18)
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Speech Recognition Threshold using Coordinate Response Measure
Prazo: Pre-test (week 1), Mid-test (week 5), Post-test (week 10), Follow-up (week 18)
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SRT stimuli from the Coordinate Response Measure are sentences that participants hear that contain a color and number (e.g., "Ready Charlie, go to blue three now").
Participants select one of 36 colored/numbered squares that matches the color-number combination of the sentence.
The dependent variable is the threshold target-to-masker ratio (TMR) as estimated based on the number of sentences correctly identified as part of a series of 20 test trials in which TMR progressively reduced every two trials.
Lower scores indicate better performance.
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Pre-test (week 1), Mid-test (week 5), Post-test (week 10), Follow-up (week 18)
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Gap Detection Task
Prazo: Pre-test (week 1), Post-test (week 10)
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Temporal sensitivity to silent gaps between pairs of brief (4 ms) bandlimited stimuli.
The gap duration will start at 6 ms, and be reduced from there using a staircase procedure.
The dependent variable is the threshold (in ms) at which participants stop responding accurately.
Lower scores indicate better performance.
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Pre-test (week 1), Post-test (week 10)
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Spectrotemporal Sensitivity Task
Prazo: Pre-test (week 1), Post-test (week 10)
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Stimuli are either unmodulated or are spectrotemporally modulated in amplitude using two cycles/octave for the spectral modulation and 4 Hz for the temporal modulation.
Modulation depth in decibels (dB) will be adaptively varied to estimate threshold.
The dependent variable is the threshold (in dB) at which participants stop responding accurately.
Lower scores indicate better performance.
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Pre-test (week 1), Post-test (week 10)
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Monaural and Binaural Sensitivity to Frequency Modulation Task
Prazo: Pre-test (week 1), Post-test (week 10)
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The stimulus is a pure tone that is modulated sinusoidally and varies at a rate of 2 Hz.
The task is to detect differences between modulated and unmodulated tones, and the modulated "depth" in Hz is tracked adaptively.
The BFM stimuli are identical to MFM except for presentation to both ears with increasing frequency in one ear and decreasing in the other.
The dependent variable is the threshold (in Hz) at which participants stop responding accurately.
Lower scores indicate better performance.
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Pre-test (week 1), Post-test (week 10)
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Audio Visual Divided Attention Task
Prazo: Pre-test (week 1), Mid-test (week 5), Post-test (week 10), Follow-up (week 18)
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Participants are presented with auditory sequences of spoken digits and visual sequences of written letters.
Participants will be instructed to recall a particular sequence either in advance (assesses selective attention) or only afterwards (assesses divided attention).
The dependent variable is the fall-off of reaction time and accuracy across a the single-stream task.
Higher scores indicate better performance.
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Pre-test (week 1), Mid-test (week 5), Post-test (week 10), Follow-up (week 18)
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Paced Serial Addition Task
Prazo: Pre-test (week 1), Post-test (week 10), Follow-up (week 18)
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Participants are shown a series of numbers one at a time.
Their goal is to add the last two numbers presented and select the answer that correctly adds the two numbers.
Participants are shown single digit numbers and are required to answer on a number pad .
The dependent variable is the total number of correct responses.
Higher scores indicate better performance.
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Pre-test (week 1), Post-test (week 10), Follow-up (week 18)
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Letter-Number Sequencing Task
Prazo: Pre-test (week 1), Post-test (week 10), Follow-up (week 18)
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The participant is presented with a mixed order of letters and numbers and must remember and sort them numerically and alphabetically.
Set size starts at 2 and increases until the participants fail to recall both trials at a given set size.
The dependent variable is Score (total number of correct trials).
Higher scores indicate better performance.
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Pre-test (week 1), Post-test (week 10), Follow-up (week 18)
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Auditory N-back Task
Prazo: Pre-test (week 1), Post-test (week 10), Follow-up (week 18)
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Participants are presented with a consecutive stream of tones through headphones, and are asked to tap on the screen every time the currently presented item matches the one presented N items earlier.
The dependent variable consists of accuracy on each of the levels calculated as hits/(hits+misses+false alarms).
Higher scores indicate better performance.
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Pre-test (week 1), Post-test (week 10), Follow-up (week 18)
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Outras medidas de resultado
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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POMS 2-A
Prazo: Pre-test (week 1), Post-test (week 10), Follow-up (week 18)
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Self report measure assessing current mood states in adults.
Participants rate descriptive mood words according to how they feel during the specified assessment timeframe using a 5-point response scale.
The dependent variable is Total Mood Disturbance (TMD) score, with higher values indicating greater overall mood disturbance.
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Pre-test (week 1), Post-test (week 10), Follow-up (week 18)
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Ryff's Scale of Psychological Well-being Score
Prazo: Pre-test (week 1), Follow-up (week 18), Follow-up (week 18)
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Self-report questionnaire that assesses six domains of well-being (self-acceptance, environmental mastery, positive relations, purpose in life, personal growth, and autonomy).
Higher scores indicate greater perceived well-being.
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Pre-test (week 1), Follow-up (week 18), Follow-up (week 18)
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Short Warwick-Edinburgh Mental Wellbeing Scale (SWEMWBS)
Prazo: Pre-test (week 1), Follow-up (week 18), Follow-up (week 18)
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A 7-item self-report measure assessing positive mental well-being.
Participants rate statements about their thoughts and feelings over the specified assessment period using a 5-point response scale.
The dependent variable is the total well-being score, with higher values indicating greater mental well-being.
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Pre-test (week 1), Follow-up (week 18), Follow-up (week 18)
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Musicality Survey
Prazo: Pre-test (week 1), Follow-up (week 18)
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Self-report survey of participants' past musical experiences, with items including the Active Engagement, Perceptual Abilities, and Emotions factors from the Goldsmith's Music Sophistication Index, the Absorption factor from the Extended Barcelona Music Reward Questionnaire, and selected items from the Ollen Music Sophistication Index.
Higher scores indicate greater self-reported musical involvement and ability.
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Pre-test (week 1), Follow-up (week 18)
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Short-Musical Ear Test
Prazo: Pre-test (week 1), Post-test (week 10), Follow-up (week 18)
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Participants will listen to a series of short rhythmic and melodic sequences and determine whether each pair is identical or different from one another.
The dependent variable is percentage correct.
Higher scores indicate better performance.
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Pre-test (week 1), Post-test (week 10), Follow-up (week 18)
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Older Adult Cognitive Battery
Prazo: Pre-test (week 1), Post-test (week 10), Follow-up (week 18)
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This digitally administered battery includes a word list learning and complex figure drawing task, a revised version of the Boston Naming Task, a vocabulary task (Shipley), the Trail Making Task (parts A and B), and an older-adult version of the University of California Matrix Reasoning Task.
The dependent variables are percentage correct for Boston Naming Shipley, and Matrix Reasoning where, higher scores indicate better performance.
For the Trail Making Task, the dependent variable is the time difference between parts A and B, and lower scores indicate better performance.
For the word-list learning task, the dependent variable is the total number of words correctly recalled across the learning trials, with higher values indicating better performance.
For the complex figure task, the dependent variable is the total accuracy score based on correctly reproduced figure elements, with higher values indicating better performance.
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Pre-test (week 1), Post-test (week 10), Follow-up (week 18)
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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Investigadores
- Investigador principal: Susanne Jaeggi, PhD, Northeastern University
- Investigador principal: Aaron Seitz, PhD, Northeastern University
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Estimado)
14 de agosto de 2026
Conclusão Primária (Estimado)
31 de maio de 2027
Conclusão do estudo (Estimado)
31 de agosto de 2027
Datas de inscrição no estudo
Enviado pela primeira vez
14 de agosto de 2026
Enviado pela primeira vez que atendeu aos critérios de CQ
14 de agosto de 2026
Primeira postagem (Real)
19 de agosto de 2026
Atualizações de registro de estudo
Última Atualização Postada (Real)
19 de agosto de 2026
Última atualização enviada que atendeu aos critérios de controle de qualidade
14 de agosto de 2026
Última verificação
1 de agosto de 2026
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Outros números de identificação do estudo
- 26-06-08
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
SIM
Descrição do plano IPD
All individual participant data (anonymized)
Prazo de Compartilhamento de IPD
Data will be available persistently at the conclusion of the study.
Critérios de acesso de compartilhamento IPD
There are no access criteria.
Tipo de informação de suporte de compartilhamento de IPD
- SEIVA
- CIF
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Não
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Não
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .