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Идёт набор NCT05365646

Fall Risk Assessment and Speech Intelligibility Enhancement Using In-ear Device

Без фазы С лечением Hearing Loss Dizziness Vertigo Fall Related Injury Risk

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 aids equipped with motion sensing abilities.
Кому может быть актуально
Состояния в реестре: Hearing Loss, Dizziness, Vertigo, Fall Related Injury Risk. Базовые параметры: от 55 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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Обзор

The purpose of this study is to develop and validate methods to use hearing aids equipped with embedded sensors and artificial intelligence to assist in the assessment of fall risk and in the implementation of interventions aimed at reducing the risk of falling, as well as to improve speech intelligibility in quiet and in background noise, track physical activity, and social engagement. The investigators hope is that the knowledge that is generated through this study will ultimately translate to the clinical setting and will help reduce the likelihood that individuals experience a fall, and improve the quality of hearing in individuals who wear hearing aids.

Вмешательства

  • Устройство Hearing aids equipped with motion sensing abilities
    Participants will wear hearing aids that will assess their movement, and fall risk.

Первичные конечные точки

  • Fall risk assessment using CDC's STEADI protocol [Срок оценки: approximately 15 minutes to assess]
  • Timed Up and Go Test [Срок оценки: approximately 15 minutes to assess]
  • 30-Second Chair Stand Test [Срок оценки: approximately 15 minutes to assess]
  • 4-Stage Balance Test [Срок оценки: approximately 15 minutes to assess]
  • Consonant-Nucleus-Consonant (CNC) [Срок оценки: Approximately 10-15 minutes.]
  • Quick Speech-in-Noise (QuickSIN) [Срок оценки: Approximately 10-15 minutes.]
  • Words-in-Noise (WIN) [Срок оценки: Approximately 10-15 minutes.]
  • Nonsense Syllable Test (NST) [Срок оценки: Approximately 10-15 minutes.]
Вторичные конечные точки (10)
  • Fall screening questionnaire using CDC's STEADI protocol [Срок оценки: Approximately 2 minutes.]
  • Listening Effort Questionnaire Scale Score [Срок оценки: Approximately 5 minutes.]
  • Auditory Lifestyle and Demand Scale Score [Срок оценки: Approximately 5 minutes.]
  • User Experience Questionnaire [Срок оценки: Approximately 2 minutes.]
  • Demographic and Health Questionnaires [Срок оценки: Approximately 15 minutes.]
  • Orthostatic Blood Pressure [Срок оценки: Approximately 15 minutes.]
  • Pure-Tone Audiometry [Срок оценки: Approximately 15 minutes.]
  • Activities-Specific Balance Confidence Questionnaire [Срок оценки: Approximately 10 minutes.]
  • Speech, Spatial Qualities of Hearing Scale (SSQ) [Срок оценки: Approximately 10 minutes.]
  • Hearing Aid Data [Срок оценки: Approximately 5 minutes.]

Критерии участия

Критерии включения

  • Age 55 years or older
  • Bilateral hearing aid user
  • Able to consent in English
  • Having access to a phone capable of running the mobile app required for the study
  • Screen for fall risk ("Yes" to any question: Feels unsteady when standing or walking? Worries about falling? Has fallen in past year? If the participant has fallen: how many times? were they injured/hurt?)
  • Ambulatory without need for a wheelchair

Критерии исключения

  • People with mobility restrictions (e.g., wheelchair bound) that would prevent the performance of the functional assessments.
  • People with severe movement (e.g., Advanced Parkinson's disease) or cognitive (e.g., advanced dementia) disorders that would prevent the individual from either performing the functional assessments, or would lead to restricted activities that would prevent motion data from being collected according to the goal of the study.
  • Inability to understand, consent, and complete requirements including verbal instructions and non-ambulatory/wheelchair-dependent.

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Нерандомизированное
Модель
Параллельные группы
Маскирование
Открытое
Основная цель
Скрининг

Центры проведения

США · 1 центр
  • Stanford Ear Institute — Palo Alto

Публикации

  • Rahme M, Folkeard P, Scollie S. Evaluating the Accuracy of Step Tracking and Fall Detection in the Starkey Livio Artificial Intelligence Hearing Aids: A Pilot Study. Am J Audiol. 2021 Mar 10;30(1):182-189. doi: 10.1044/2020_AJA-20-00105. Epub 2020 Dec 7. PMID 33284647
  • Burwinkel JR, Xu B, Crukley J. Preliminary Examination of the Accuracy of a Fall Detection Device Embedded into Hearing Instruments. J Am Acad Audiol. 2020 Jun;31(6):393-403. doi: 10.3766/jaaa.19056. Epub 2020 Aug 3. PMID 31914373

Идентификаторы

NCT: NCT05365646 · 60900

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗