Clinical trial NCT06368830: Oral and Swallowing Function in Older Adults
Official title: Characterizing Oral and Swallowing Function in Older Adults Presenting to the Emergency Department
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Oropharyngeal Dysphagia
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
First posted: 2024-04-16
Enrollment: 200
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Older adults presenting to the emergency department

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Age ≥ 60
* Clinically stable and able (not NPO) to safely drink water and eat a saltine cracker per ED provider

Exclusion Criteria:

* Prisoner
* Non-English speaking

Primary outcomes:
measure: Positive oropharyngeal dysphagia screen prevalence
timeFrame: During emergency department visit, approximately 2-5 minutes for bedside dysphagia screen and 5-10 minutes for patient reported swallowing function
Secondary outcomes:
measure: Mean brief oral health status examination (BOHSE) score
timeFrame: During emergency department visit, approximately 2-5 minutes
measure: Oral dryness prevalence
timeFrame: During emergency department visit, up to 10 minutes for saliva collection
measure: Decreased tongue pressure prevalence
timeFrame: During emergency department visit, approximately 2-5 minutes
measure: Decreased masticatory function prevalence
timeFrame: During emergency department visit, approximately 2-5 minutes
measure: pH of saliva sample
timeFrame: During emergency department visit, up to 10 minutes for saliva collection
measure: Extensional viscosity of saliva sample
timeFrame: During emergency department visit, up to 10 minutes for saliva collection
measure: Salivary Substance P Concentration
timeFrame: During emergency department visit, up to 10 minutes for saliva collection
measure: Oral microbiome
timeFrame: During emergency department visit, up to 10 minutes for saliva collection
measure: Cell barrier function
timeFrame: During emergency department visit, up to 10 minutes for saliva collection
measure: Protein composition
timeFrame: During emergency department visit, up to 10 minutes for saliva collection
measure: Gene expression
timeFrame: During emergency department visit, up to 10 minutes for saliva collection
measure: Immunofluorescent staining
timeFrame: During emergency department visit, up to 10 minutes for saliva collection
measure: Immune cell trafficking
timeFrame: During emergency department visit, up to 10 minutes for saliva collection
Other outcomes:
Locations:
city: Madison
country: United States
facility: University of Wisconsin School of Medicine and Public Health
state: Wisconsin
Study officials:
affiliation: University of Wisconsin, Madison
name: Michael S Pulia, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: