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Идёт набор NCT06689865

Innovations in Hearing Accessibility and Technology (IHAT) Study

Без фазы С лечением Hearing Loss Hearing Aids OTC Hearing Aids

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: HA-HCP, OTC-HCP, OTC-R, OTC-SF.
Кому может быть актуально
Состояния в реестре: Hearing Loss, Hearing Aids, OTC Hearing Aids. Базовые параметры: от 40 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
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Официальное название

Effectiveness Trial to Examine the Emerging Service Delivery Models for Over-the-Counter (OTC) Hearing Aids

Обзор

The research will explore outcomes of different service delivery models of over-the-counter (OTC) hearing aids by comparing them to prescription hearing aids fitted by specialists in individuals with mild to moderate hearing loss. The investigators will examine how each type affects users' experiences, behavior, thinking skills, and brain activity related to hearing. Additionally, the study will focus on what types of people prefer each hearing aid option, what helps or hinders these choices, and compare the costs of four different service options. This approach will help transition from research findings into real-world practice, providing useful information for healthcare providers and policymakers about OTC hearing aid options.

Подробное описание

The aim of the proposed project is to evaluate the effectiveness of emerging over-the-counter (OTC) service delivery models with the gold standard traditional prescription hearing aids fit by hearing care professionals (HCP) using audiology best practices. OTC service delivery models include OTC HA fit to individual users using best practices with in person HCP support (OTC-HPC), via remote consultation (OTC-R) and self-fit OTC HAs without any clinical support (OTC-SF). The study will use a prospective four-arm randomized controlled trial design with longitudinal repeated measures.

Вмешательства

  • Устройство HA-HCP
    Prescription hearing aid fit by a hearing healthcare professional using audiology best practices.
  • Устройство OTC-HCP
    Over-the-counter hearing aids fit by a hearing care professional using audiology best practices.
  • Устройство OTC-R
    OTC fit to an individual using some best practices via remote consultation.
  • Устройство OTC-SF
    Self-fit OTC hearing aids without any clinical support from HCPs.

Первичные конечные точки

  • Abbreviated Profile of Hearing Aid Benefit (APHAB) [Срок оценки: T0 = Baseline, T1 = 6 months post intervention, T2 = 12 months post intervention]
Вторичные конечные точки (5)
  • Satisfaction with Amplification in Daily Living (SADL) [Срок оценки: T0= Baseline, T1= 6 months post intervention, T2= 12 months post intervention]
  • Revised Hearing Handicap Inventory -Screening (RHHI-S) [Срок оценки: T0= Baseline, T1= 6 months post intervention, T2= 12 months post intervention]
  • Patient Global Impression of Change (PGI-C) [Срок оценки: T1= 6 months post intervention, T2= 12 months post intervention]
  • Connected Speech Test (CST) [Срок оценки: T0= Baseline, T1= 6 months post intervention, T2= 12 months post intervention]
  • Quick Speech in Noise (QuickSIN) [Срок оценки: T0= Baseline, T1= 6 months post intervention, T2= 12 months post intervention]

Критерии участия

Критерии включения

  • Adult onset, bilateral, mild-to-moderate sensorineural hearing loss documented by audiological evaluation
  • Aged 40 years or older
  • No previous HA experience greater than 3 months
  • Able to read and understand patient education materials
  • Willing to be randomized to one of the four groups, and
  • Owns a smartphone

Критерии исключения

  • Hearing loss that is too severe for OTC HAs
  • Middle ear disorders or conductive pathology present
  • Asymmetrical hearing loss
  • Diagnosed neurological condition such as dementia or Parkinson's disease or a score lower than 25 on the MOCA
  • Non-English speaking as it may impact the ability to complete our test battery

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Открытое
Основная цель
Лечение

Центры проведения

США · 2 центра
  • University of Colorado School of Medicine — Aurora
  • University of Colorado Boulder — Boulder

Публикации

  • De Sousa KC, Manchaiah V, Moore DR, Graham MA, Swanepoel W. Effectiveness of an Over-the-Counter Self-fitting Hearing Aid Compared With an Audiologist-Fitted Hearing Aid: A Randomized Clinical Trial. JAMA Otolaryngol Head Neck Surg. 2023 Jun 1;149(6):522-530. doi: 10.1001/jamaoto.2023.0376. PMID 37052929
  • De Sousa KC, Manchaiah V, Moore DR, Graham MA, Swanepoel W. Long-Term Outcomes of Self-Fit vs Audiologist-Fit Hearing Aids. JAMA Otolaryngol Head Neck Surg. 2024 Sep 1;150(9):765-771. doi: 10.1001/jamaoto.2024.1825. PMID 38990557
  • Knoetze M, Manchaiah V, De Sousa K, Moore DR, Swanepoel W. Comparing Self-Fitting Strategies for Over-the-Counter Hearing Aids: A Crossover Clinical Trial. JAMA Otolaryngol Head Neck Surg. 2024 Sep 1;150(9):784-791. doi: 10.1001/jamaoto.2024.2007. PMID 39052241

Идентификаторы

NCT: NCT06689865 · 23-2351 · R01DC021653

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗