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Following the Sound of Music

14 août 2026 mis à jour par: 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.

Aperçu de l'étude

Statut

Recrutement

Les conditions

Intervention / Traitement

Type d'étude

Interventionnel

Inscription (Estimé)

216

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

Lieux d'étude

  • États-Unis
    • Massachusetts
      • Boston, Massachusetts, États-Unis, 02115
        • Recrutement
        • Northeastern University
        • Contact:

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Adulte
  • Adulte plus âgé

Accepte les volontaires sains

Oui

La description

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

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Science basique
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Double

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: Sound of Music Plus Attention
Comportemental: Music Listening with Attentional prompts
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.
Expérimental: Sound of Music
Comportemental: Music Listening
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.
Expérimental: Sound of Tones Plus Attention
Comportemental: Tone listening with Attentional prompts
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.
Aucune intervention: Business as usual Control

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Digits-in-Noise Task
Délai: Pre-test (week 1), Mid-test (week 5), Post-test (week 10), Follow-up (week 18)
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.
Pre-test (week 1), Mid-test (week 5), Post-test (week 10), Follow-up (week 18)
Spatial Release From Masking Task
Délai: Pre-test (week 1), Mid-test (week 5), Post-test (week 10), Follow-up (week 18)
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.
Pre-test (week 1), Mid-test (week 5), Post-test (week 10), Follow-up (week 18)
Dichotic Sentence Identification Task
Délai: Pre-test (week 1), Mid-test (week 5), Post-test (week 10), Follow-up (week 18)
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.
Pre-test (week 1), Mid-test (week 5), Post-test (week 10), Follow-up (week 18)

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Revised Hearing Handicap Inventory for the Elderly (RHHI)
Délai: Pre-test (week 1), Post-test (week 10), Follow-up (week 18)
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.
Pre-test (week 1), Post-test (week 10), Follow-up (week 18)
Speech Recognition Threshold using Coordinate Response Measure
Délai: Pre-test (week 1), Mid-test (week 5), Post-test (week 10), Follow-up (week 18)
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.
Pre-test (week 1), Mid-test (week 5), Post-test (week 10), Follow-up (week 18)
Gap Detection Task
Délai: Pre-test (week 1), Post-test (week 10)
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.
Pre-test (week 1), Post-test (week 10)
Spectrotemporal Sensitivity Task
Délai: Pre-test (week 1), Post-test (week 10)
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.
Pre-test (week 1), Post-test (week 10)
Monaural and Binaural Sensitivity to Frequency Modulation Task
Délai: Pre-test (week 1), Post-test (week 10)
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.
Pre-test (week 1), Post-test (week 10)
Audio Visual Divided Attention Task
Délai: Pre-test (week 1), Mid-test (week 5), Post-test (week 10), Follow-up (week 18)
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.
Pre-test (week 1), Mid-test (week 5), Post-test (week 10), Follow-up (week 18)
Paced Serial Addition Task
Délai: Pre-test (week 1), Post-test (week 10), Follow-up (week 18)
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.
Pre-test (week 1), Post-test (week 10), Follow-up (week 18)
Letter-Number Sequencing Task
Délai: Pre-test (week 1), Post-test (week 10), Follow-up (week 18)
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.
Pre-test (week 1), Post-test (week 10), Follow-up (week 18)
Auditory N-back Task
Délai: Pre-test (week 1), Post-test (week 10), Follow-up (week 18)
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.
Pre-test (week 1), Post-test (week 10), Follow-up (week 18)

Autres mesures de résultats

Mesure des résultats
Description de la mesure
Délai
POMS 2-A
Délai: Pre-test (week 1), Post-test (week 10), Follow-up (week 18)
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.
Pre-test (week 1), Post-test (week 10), Follow-up (week 18)
Ryff's Scale of Psychological Well-being Score
Délai: Pre-test (week 1), Follow-up (week 18), Follow-up (week 18)
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.
Pre-test (week 1), Follow-up (week 18), Follow-up (week 18)
Short Warwick-Edinburgh Mental Wellbeing Scale (SWEMWBS)
Délai: Pre-test (week 1), Follow-up (week 18), Follow-up (week 18)
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.
Pre-test (week 1), Follow-up (week 18), Follow-up (week 18)
Musicality Survey
Délai: Pre-test (week 1), Follow-up (week 18)
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.
Pre-test (week 1), Follow-up (week 18)
Short-Musical Ear Test
Délai: Pre-test (week 1), Post-test (week 10), Follow-up (week 18)
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.
Pre-test (week 1), Post-test (week 10), Follow-up (week 18)
Older Adult Cognitive Battery
Délai: Pre-test (week 1), Post-test (week 10), Follow-up (week 18)
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.
Pre-test (week 1), Post-test (week 10), Follow-up (week 18)

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Northeastern University

Les enquêteurs

  • Chercheur principal: Susanne Jaeggi, PhD, Northeastern University
  • Chercheur principal: Aaron Seitz, PhD, Northeastern University

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Estimé)

14 août 2026

Achèvement primaire (Estimé)

31 mai 2027

Achèvement de l'étude (Estimé)

31 août 2027

Dates d'inscription aux études

Première soumission

14 août 2026

Première soumission répondant aux critères de contrôle qualité

14 août 2026

Première publication (Réel)

19 août 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

19 août 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

14 août 2026

Dernière vérification

1 août 2026

Plus d'information

Termes liés à cette étude

Mots clés

Autres numéros d'identification d'étude

  • 26-06-08

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

OUI

Description du régime IPD

All individual participant data (anonymized)

Délai de partage IPD

Data will be available persistently at the conclusion of the study.

Critères d'accès au partage IPD

There are no access criteria.

Type d'informations de prise en charge du partage d'IPD

  • SÈVE
  • CIF

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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