Набор скоро начнётся NCT07584837

Cochlear Implantation and Social Outcomes

— Наблюдательное Hearing Loss, Bilateral Sensorineural

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: Cochlear implant.
Кому может быть актуально: Состояния в реестре: Hearing Loss, Bilateral Sensorineural. Базовые параметры: от 60 лет · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: США
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Не всё понятно в терминах? Прочитайте наш гид для пациентов →

Обзор

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.

Вмешательства

Процедура Cochlear implant
Participants will undergo or have previously undergone cochlear implantation as part of routine clinical care, independent of this research study.

Первичные конечные точки

Audio sensor- speech arousal [Срок оценки: Baseline, optional 4-month follow-up]
Audio sensor- speech activity [Срок оценки: Baseline, optional 4-month follow-up]

Вторичные конечные точки (12)

Cognitive test- MoCA [Срок оценки: Baseline, optional 4-month follow-up]
UCLA Loneliness Scale [Срок оценки: Baseline, optional 4 months follow-up]
Lubben Social Network Scale (LSNS-6) [Срок оценки: Baseline, optional 4 months follow-up]
Duke Social Support Index (DSSI-11) [Срок оценки: Baseline, optional 4-months follow-up]
Hearing Handicap Inventory for the Elderly - Screening Version (HHIE-S) [Срок оценки: Baseline, optional 4 months follow-up]
Generalized Anxiety Disorder 7-item (GAD-7) Scale [Срок оценки: Baseline, optional 4 months follow-up]
Center for Epidemiologic Studies Depression Scale (CES-D) [Срок оценки: Baseline, optional 4 months follow-up]
Short Form Health Survey - 12 Item (SF-12) [Срок оценки: Baseline, optional 4-months follow-up]
Short Assessment of Health Literacy (SAHL) [Срок оценки: Baseline, optional 4-months follow-up]
EEG Measure - Mismatch negativity amplitude [Срок оценки: Baseline, optional 4-month follow-up]
EEG Measure - Mismatch negativity latency [Срок оценки: Baseline, optional 4-month follow-up4-month follow-up]
EEG Measure - P300 amplitude [Срок оценки: Baseline, optional 4-month follow-up]

Критерии участия

Критерии включения

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.