Following the Sound of Music
14 sierpnia 2026 zaktualizowane przez: 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.
Przegląd badań
Status
Rekrutacyjny
Warunki
Typ studiów
Interwencyjne
Zapisy (Szacowany)
216
Faza
- Nie dotyczy
Kontakty i lokalizacje
Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.
Kontakt w sprawie studiów
- Nazwa: Audrey Carrillo, MA
- Numer telefonu: 626-482-8091
- E-mail: a.carrillo@northeastern.edu
Lokalizacje studiów
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Massachusetts
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Boston, Massachusetts, Stany Zjednoczone, 02115
- Rekrutacyjny
- Northeastern University
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Kontakt:
- Audrey Carrillo, MA
- Numer telefonu: 626-482-8091
- E-mail: a.carrillo@northeastern.edu
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-
Kryteria uczestnictwa
Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.
Kryteria kwalifikacji
Wiek uprawniający do nauki
- Dorosły
- Starszy dorosły
Akceptuje zdrowych ochotników
Tak
Opis
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 studiów
Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Podstawowa nauka
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Podwójnie
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
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Eksperymentalny: 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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Eksperymentalny: 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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Eksperymentalny: 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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Brak interwencji: Business as usual Control
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Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Digits-in-Noise Task
Ramy czasowe: 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)
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Spatial Release From Masking Task
Ramy czasowe: 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)
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Dichotic Sentence Identification Task
Ramy czasowe: 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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Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Revised Hearing Handicap Inventory for the Elderly (RHHI)
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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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Inne miary wyników
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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POMS 2-A
Ramy czasowe: 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
Ramy czasowe: 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)
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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.
|
Pre-test (week 1), Post-test (week 10), Follow-up (week 18)
|
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Older Adult Cognitive Battery
Ramy czasowe: 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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Współpracownicy i badacze
Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.
Sponsor
Śledczy
- Główny śledczy: Susanne Jaeggi, PhD, Northeastern University
- Główny śledczy: Aaron Seitz, PhD, Northeastern University
Daty zapisu na studia
Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.
Główne daty studiów
Rozpoczęcie studiów (Szacowany)
14 sierpnia 2026
Zakończenie podstawowe (Szacowany)
31 maja 2027
Ukończenie studiów (Szacowany)
31 sierpnia 2027
Daty rejestracji na studia
Pierwszy przesłany
14 sierpnia 2026
Pierwszy przesłany, który spełnia kryteria kontroli jakości
14 sierpnia 2026
Pierwszy wysłany (Rzeczywisty)
19 sierpnia 2026
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
19 sierpnia 2026
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
14 sierpnia 2026
Ostatnia weryfikacja
1 sierpnia 2026
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Inne numery identyfikacyjne badania
- 26-06-08
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
TAK
Opis planu IPD
All individual participant data (anonymized)
Ramy czasowe udostępniania IPD
Data will be available persistently at the conclusion of the study.
Kryteria dostępu do udostępniania IPD
There are no access criteria.
Typ informacji pomocniczych dotyczących udostępniania IPD
- SOK ROŚLINNY
- ICF
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Nie
Bada produkt urządzenia regulowany przez amerykańską FDA
Nie
Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .