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Cochlear Implantation and Social Outcomes

17 czerwca 2026 zaktualizowane przez: Janet Choi, University of Southern California

The goal of this clinical trial is to learn if hearing devices, like cochlear implants, affect social and cognitive function of older adults. The main questions the researchers want to answer are:

  • How social are older adults with hearing loss before and after using hearing devices?
  • How well do older adults with hearing loss think before and after using hearing devices?
  • For older adults who have hearing loss and use hearing devices, do changes in social interaction explain changes in how well they think (cognitive function)?
  • Do brainwaves (EEGs) in older adults with hearing loss change after using hearing devices?
  • Are there differences in how social older adults with hearing loss are compared to older adults without hearing loss?

What Participants Will Do:

  • Participants will take questionnaires for around 60 minutes. Questionnaires will ask participants about their background, health, hearing, and how social they are. Another set of questionnaires will check their thinking ability or cognition.
  • Participants will wear an audio sensor (TILES Audio Recorder on Jelly Mobile phone) for 2 weeks. The sensor will collect and store information about a participant's voice during conversations. Once the device has information about a participant's voice such as pitch and tone it will store this information and delete the audio recording. Words spoken during conversations will be deleted.
  • (Optional) Participants can choose to participate in a 45-60-minute EEG (electroencephalogram) recording session. Participants will have sensors placed on top of their heads. Sensors will record the participants' brainwaves. Sounds will be played to see how participants' brainwaves change when they hear sounds. Eligible participants will be invited to participate in 4-month follow-up study.

Przegląd badań

Status

Jeszcze nie rekrutacja

Warunki

Interwencja / Leczenie

Typ studiów

Obserwacyjny

Zapisy (Szacowany)

40

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Kontakt w sprawie studiów

Lokalizacje studiów

  • Stany Zjednoczone
    • California
      • Los Angeles, California, Stany Zjednoczone, 90033
        • University of Southern California
        • Kontakt:

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

Metoda próbkowania

Próbka bez prawdopodobieństwa

Badana populacja

Individuals meeting the inclusion criteria will be recruited from the affiliated tertiary hospitals.

Opis

Inclusion Criteria:

  • Age >= 60 years
  • English or Spanish speaking
  • older adults with bilateral moderate to profound sensorineural hearing loss who are candidates for cochlear implants or have undergone cochlear implantation.

Exclusion Criteria:

  • Age <60 years
  • Unable to complete questionnaires in English or Spanish

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

Kohorty i interwencje

Grupa / Kohorta
Interwencja / Leczenie
Adults with bilateral hearing loss (cochlear implant users or candidates)
Participants with bilateral moderate to profound hearing loss who are candidates for cochlear implant or currently using cochlear implants
Procedura: Cochlear implant
Participants will undergo or have previously undergone cochlear implantation as part of routine clinical care, independent of this research study.

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Audio sensor- speech arousal
Ramy czasowe: Baseline, optional 4-month follow-up
The audio sensor employs deep-learning-based multimodal speech pattern modeling of participants' own voice activities to extract speech arousal and speech activities. Speech arousal measures include the percentage of strong arousals, serving as a proxy of enhanced engagement in conversations.
Baseline, optional 4-month follow-up
Audio sensor- speech activity
Ramy czasowe: Baseline, optional 4-month follow-up
The audio sensor employs deep-learning-based multimodal speech pattern modeling of participants' own voice activities to extract speech arousal and speech activities. Speech activity measures include the intersession time (the interval between speech sessions, representing the frequency of conversation engagement).
Baseline, optional 4-month follow-up

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
UCLA Loneliness Scale
Ramy czasowe: Baseline, optional 4 months follow-up
The UCLA Loneliness Scale is a 20-item self-report measure assessing subjective feelings of loneliness and social isolation. Total scores range from 20 to 80, with higher scores indicating greater loneliness and worse outcomes. Minimum score: 20; maximum score: 80. Higher scores represent worse outcomes.
Baseline, optional 4 months follow-up
Lubben Social Network Scale (LSNS-6)
Ramy czasowe: Baseline, optional 4 months follow-up
The Lubben Social Network Scale (LSNS-6) is a 6-item self-report measure assessing social engagement and perceived social support from family and friends. Total scores range from 0 to 30, with higher scores indicating larger and more supportive social networks (better outcomes). Minimum score: 0; maximum score: 30. Higher scores represent better outcomes.
Baseline, optional 4 months follow-up
Hearing Handicap Inventory for the Elderly - Screening Version (HHIE-S)
Ramy czasowe: Baseline, optional 4 months follow-up
The HHIE-S is a 10-item self-report questionnaire assessing the emotional and social/situational effects of hearing loss in older adults. Total scores range from 0 to 40, with higher scores indicating greater perceived hearing handicap and worse hearing-related quality of life. Minimum score: 0; maximum score: 40. Higher scores represent worse outcomes.
Baseline, optional 4 months follow-up
Generalized Anxiety Disorder 7-item (GAD-7) Scale
Ramy czasowe: Baseline, optional 4 months follow-up
The GAD-7 is a 7-item self-report questionnaire assessing the severity of generalized anxiety symptoms over the past two weeks. Total scores range from 0 to 21, with higher scores indicating greater anxiety severity and worse outcomes. Minimum score: 0; maximum score: 21. Higher scores represent worse outcomes.
Baseline, optional 4 months follow-up
Center for Epidemiologic Studies Depression Scale (CES-D)
Ramy czasowe: Baseline, optional 4 months follow-up
The CES-D is a 20-item self-report questionnaire assessing depressive symptoms in the general population over the past week. Total scores range from 0 to 60, with higher scores indicating greater depressive symptom severity and worse outcomes. Minimum score: 0; maximum score: 60. Higher scores represent worse outcomes.
Baseline, optional 4 months follow-up
Cognitive test- MoCA
Ramy czasowe: Baseline, optional 4-month follow-up
Montreal Cognitive Assessment (MoCA) The MoCA is a brief cognitive screening tool assessing multiple domains including memory, attention, executive function, language, visuospatial skills, and orientation. The standard MoCA total score ranges from 0 to 30, with higher scores indicating better cognitive function (better outcomes).
Baseline, optional 4-month follow-up
Duke Social Support Index (DSSI-11)
Ramy czasowe: Baseline, optional 4-months follow-up
The DSSI-11 is an 11-item self-report measure assessing social support across social interaction and subjective support domains. Total scores range from 10 to 30, with higher scores indicating greater perceived social support (better outcomes). Minimum score: 10; maximum score: 30. Higher scores represent better outcomes.
Baseline, optional 4-months follow-up
Short Form Health Survey - 12 Item (SF-12)
Ramy czasowe: Baseline, optional 4-months follow-up
The SF-12 is a 12-item self-report measure assessing overall health-related quality of life across physical and mental domains. Scores are typically summarized into Physical Component Summary (PCS) and Mental Component Summary (MCS) scores. When reported as a combined or transformed total score ranging from 0 to 200, higher scores indicate better health-related quality of life (better outcomes). Minimum score: 0; maximum score: 200. Higher scores represent better outcomes.
Baseline, optional 4-months follow-up
Short Assessment of Health Literacy (SAHL)
Ramy czasowe: Baseline, optional 4-months follow-up
The SAHL is an 18-item word recognition and comprehension test assessing health literacy. Total scores range from 0 to 18, with higher scores indicating better health literacy (better outcomes). Minimum score: 0; maximum score: 18. Higher scores represent better outcomes.
Baseline, optional 4-months follow-up
EEG Measure - Mismatch negativity amplitude
Ramy czasowe: Baseline, optional 4-month follow-up
Mismatch Negativity (MMN) amplitude is an event-related potential (ERP) measure of automatic auditory change detection and sensory discrimination. EEG recordings will be obtained while participants complete an auditory oddball task. MMN amplitude will be quantified as the mean negative deflection (µV) elicited by deviant auditory stimuli relative to standard stimuli within the predefined MMN time window.
Baseline, optional 4-month follow-up
EEG Measure - Mismatch negativity latency
Ramy czasowe: Baseline, optional 4-month follow-up4-month follow-up
Mismatch Negativity (MMN) latency is an event-related potential (ERP) measure of the timing of automatic auditory change detection and sensory discrimination. EEG recordings will be obtained while participants complete an auditory oddball task. MMN latency will be quantified as the time interval (milliseconds [ms]) from stimulus onset to the peak negative MMN response elicited by deviant auditory stimuli within the predefined MMN time window.
Baseline, optional 4-month follow-up4-month follow-up
EEG Measure - P300 amplitude
Ramy czasowe: Baseline, optional 4-month follow-up
P300 amplitude is an event-related potential (ERP) measure of attentional resource allocation and cognitive processing of task-relevant stimuli. EEG recordings will be obtained while participants complete an auditory oddball task. P300 amplitude will be quantified as the peak positive deflection (microvolts [µV]) elicited by target stimuli within the predefined P300 time window following stimulus presentation.
Baseline, optional 4-month follow-up
EEG Measure - P300 latency
Ramy czasowe: Baseline, optional 4-month follow-up
P300 latency is an event-related potential (ERP) measure of the speed of cognitive processing and stimulus evaluation. EEG recordings will be obtained while participants complete an auditory oddball task. P300 latency will be quantified as the time interval (milliseconds [ms]) from stimulus onset to the peak positive P300 response elicited by target stimuli within the predefined P300 time window.
Baseline, optional 4-month follow-up

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

University of Southern California

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)

1 lipca 2027

Zakończenie podstawowe (Szacowany)

31 grudnia 2029

Ukończenie studiów (Szacowany)

31 grudnia 2030

Daty rejestracji na studia

Pierwszy przesłany

6 maja 2026

Pierwszy przesłany, który spełnia kryteria kontroli jakości

6 maja 2026

Pierwszy wysłany (Rzeczywisty)

13 maja 2026

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

22 czerwca 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

17 czerwca 2026

Ostatnia weryfikacja

1 czerwca 2026

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • APP-26-02104

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

NIE

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 .

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