OTC Hearing Aid and MCI

Официальное название

Over-the-counter Hearing Aids and Mild Cognitive Impairment

Обзор

The goal of this study is to better understand if, in patients with mild to moderate hearing loss who are also experiencing mild cognitive impairment (MCI) or Alzheimer's disease and related dementias (ADRD), Over-the-Counter (OTC) hearing aids: 1. improve communication 2. Whether the magnitude of benefit depends on the patient's level of cognitive disability, 3. Whether alternative remediation (such as targeted communication strategies) offer similar benefits. Participants and a communication partner will be randomized into an OTC first or Communication Strategies first arm, where participants will receive communication strategy information customized for those with cognitive impairment.

Подробное описание

This is a single blind cross-over study comparing OTC Hearing Aids to communication strategies information/counseling and their impact on communication between a person who has hearing loss and MCI and a communication partner. Due to the nature of the study, it will not be possible to blind the participants to which arm they are in, but the scorers will be blinded.

Вмешательства

• Устройство Over the counter hearing aid
  An over the counter hearing aid is a device that provides amplification appropriate for individuals with mild to moderate hearing loss. Participants will receive the devices with typical directions and have one scheduled remote visit one week after receiving devices with an audiologist.
• Поведенческое Communication Strategies Information/Counseling
  Communication Strategies provide information meant to help an individual compensate for hearing loss. The information provides tips both for the individual with hearing loss and for those communicating. People who choose not to pursue hearing aids will typically be given communication strategies information to help them manage their hearing loss. Participants will receive the counseling information in the mail and then have a 1 week follow-up appointment with an audiologist.

Первичные конечные точки

• Perception of Conversation Index - Dementia Alzheimer's Type (PCI-DAT) [Срок оценки: Baseline at enrollment, then after 4 weeks of using each intervention]

Вторичные конечные точки (1)

• Hearing Handicap Inventory for the Elderly (HHIE) [Срок оценки: Baseline at enrollment, then after 4 weeks of using each intervention]

Критерии участия

Критерии включения

• Over 60 years of age
• Mild dementia or mild cognitive impairment. Diagnosis will be made at participating memory evaluation centers (see recruitment).
• Mild to moderate bilateral hearing loss and no current hearing aid use.
• A communication partner who is able and willing to participate in the study.
• No vision impairment that would interfere with the ability to complete study tasks (i.e., legally blind, severe cataracts, or macular degeneration)
• Able to provide own consent as evaluated by the Consent Assessment

Критерии исключения

• Clinically significant unstable or progressive medical conditions, or conditions which, in the opinion of the investigator(s) places the participant at unacceptable risk if he or she were to participate in the study.
• History of unresolved communication difficulties following another neurological problem (i.e., stroke or brain tumor), neurodevelopmental disorder (i.e., Down's syndrome), or head/neck cancer
• Positive history of major psychiatric disorder (i.e., schizophrenia, significant untreated depression)
• Co-enrolled in other intervention studies targeting hearing, language, or communication strategies.
• History or current fluctuating hearing loss

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Перекрёстный дизайн

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

США · 3 центра

• Northwestern University HA Lab — Evanston
• La Crosse Mayo Clinic — La Crosse
• UW Madison — Madison

Идентификаторы

NCT: NCT06112860 · STU00219514

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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