Oral and Swallowing Function in Older Adults
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: 3-ounce water swallow test, Kayser-Jones Brief Oral Health Status Examination (BOHSE), Tongue pressure, Test of Masticating and Swallowing Solids (TOMASS).
- Кому может быть актуально
- Состояния в реестре: Oropharyngeal Dysphagia. 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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Официальное название
Characterizing Oral and Swallowing Function in Older Adults Presenting to the Emergency Department
Обзор
The purpose of this study is to learn about oral and swallowing function in older adults presenting to the emergency department. The hypothesis is that older adults often have problems with oral and swallowing function and these problems relate to other conditions. Study activities are done during the emergency department visit and include providing saliva samples, completing a bedside water swallow test, completing oral function assessments, completing respiratory function tests, and answering survey questions.
Подробное описание
Oropharyngeal dysphagia is characterized by changes in swallow event timing, biomechanics, and pressure generation that occur with advancing age resulting in aspiration of bacteria-laden saliva, food, and liquid into the lungs. Currently, oral and swallowing function is not routinely or comprehensively assessed in older adults despite poor oral health and oropharyngeal dysphagia being known risk factors for pneumonia, the leading infectious cause of mortality among adults 65+. This study seeks to extensively characterize oral and swallowing function in older adults presenting to the emergency department to clarify the relationship of oral hypofunction, dysphagia, and the upper airway microbiome. To achieve this aim, study procedures include a bedside dysphagia screen, oral health assessment, tongue pressure measurement, masticatory function assessment, respiratory function tests, salivary compositional analysis, oral microbiome analysis, and microphysiological system analysis which applies saliva samples to a bronchiolar lumen model to mimic aspiration and quantify cellular and tissue responses to the saliva microbiome and secreted mediators.
Per amendment approved 10/29/2025: Saliva samples for microbiota analysis will not be collected from participants enrolled after 10/22/2025.
Вмешательства
- Диагностический тест 3-ounce water swallow test
Bedside water swallow dysphagia screen where vocal quality of the participant is assessed before and after swallowing 3 ounces of water - Диагностический тест Kayser-Jones Brief Oral Health Status Examination (BOHSE)
Scored assessment of the lymph nodes, lips, tongue, tissue inside of cheek, floor and roof of mouth, gums between teeth and/or under artificial teeth, saliva, condition of natural/artificial teeth, chewing position of teeth, and oral cleanliness - Диагностический тест Tongue pressure
Maximum isometric lingual pressure at the front and back of tongue will be measured by placing an air-filled pressure bulb on the surface of the oral tongue and having participants press the bulb "as hard as possible" against the hard palate - Диагностический тест Test of Masticating and Swallowing Solids (TOMASS)
Measurement of bites, masticatory cycles, swallows, and time taken to consume a cracker - Диагностический тест Respiratory function tests
Participants will take a maximum inhalation and forcefully exhale into a spirometer to measure maximum expiratory pressure (MEP), fully exhale their air and take a maximal inhalation into the spirometer to measure maximum inspiratory pressure (MIP), and produce a single strong cough into to spirometer to measure peak expiratory flow (PEF) and forced expiratory volume (FEV1)
Первичные конечные точки
- Positive oropharyngeal dysphagia screen prevalence [Срок оценки: During emergency department visit, approximately 2-5 minutes for bedside dysphagia screen and 5-10 minutes for patient reported swallowing function]
Вторичные конечные точки (12)
- Mean brief oral health status examination (BOHSE) score [Срок оценки: During emergency department visit, approximately 2-5 minutes]
- Oral dryness prevalence [Срок оценки: During emergency department visit, up to 10 minutes for saliva collection]
- Decreased tongue pressure prevalence [Срок оценки: During emergency department visit, approximately 2-5 minutes]
- Decreased masticatory function prevalence [Срок оценки: During emergency department visit, approximately 2-5 minutes]
- pH of saliva sample [Срок оценки: During emergency department visit, up to 10 minutes for saliva collection]
- Extensional viscosity of saliva sample [Срок оценки: During emergency department visit, up to 10 minutes for saliva collection]
- Salivary Substance P Concentration [Срок оценки: During emergency department visit, up to 10 minutes for saliva collection]
- Oral microbiome [Срок оценки: During emergency department visit, up to 10 minutes for saliva collection]
- Cell barrier function [Срок оценки: During emergency department visit, up to 10 minutes for saliva collection]
- Protein composition [Срок оценки: During emergency department visit, up to 10 minutes for saliva collection]
- Gene expression [Срок оценки: During emergency department visit, up to 10 minutes for saliva collection]
- Immunofluorescent staining [Срок оценки: During emergency department visit, up to 10 minutes for saliva collection]
Критерии участия
Критерии включения
- Age ≥ 60
- Clinically stable and able (not NPO) to safely drink water and eat a saltine cracker per ED provider
Критерии исключения
- Prisoner
- Non-English speaking
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Модель наблюдения
- Когортное
Центры проведения
США · 1 центр
- University of Wisconsin School of Medicine and Public Health — Madison
Идентификаторы
NCT: NCT06368830 · 2024-0337 · A534100 · Protocol Version 10/22/25