Идёт набор NCT06781749

New Approach to Objectively Measure Social Engagement in Older Adults With Hearing Loss

— Наблюдательное Hearing Loss, Bilateral (Causes Other Than Tumors)

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: Hearing aid use.
Кому может быть актуально: Состояния в реестре: Hearing Loss, Bilateral (Causes Other Than Tumors). 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 →

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Обзор

The goal of this clinical trial is to learn if hearing devices, like hearing aids, 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

Устройство Hearing aid use
Hearing aid use will be discussed with all eligible participants with hearing loss and will be encouraged to pursue hearing aid fitting through standard clinical indications via participants' insurance and audiologists.

Первичные конечные точки

Audio sensor- speech activity [Срок оценки: Baseline and 4-month after hearing aid use]
Audio sensor- speech arousal [Срок оценки: Baseline, 4-month after hearing aid use]

Вторичные конечные точки (10)

EEG Measures [Срок оценки: Baseline, 4-month after hearing aid use]
Cognitive test- MoCA [Срок оценки: Baseline and 4-month after hearing aid use]
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]

Критерии участия

Критерии включения

Age >= 60 years
English or Spanish speaking
Group 1- older adults with normal hearing defined as speech frequency PTA <25dB HL in bilateral ears
Group 2- older adults with bilateral hearing loss who are not using hearing aids
Group 3- older adults with bilateral hearing loss, who are currently using hearing aids