Oral and Swallowing Function in Older Adults

Oropharyngeal Dysphagia Clinical Trial

Official title:

Characterizing Oral and Swallowing Function in Older Adults Presenting to the Emergency Department

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06368830
• Other study ID #: 2024-0337
• Secondary ID: A534100Protocol
• Status: Recruiting
• Start date: June 3, 2024
• Est. completion date: May 2026

Study information

• Verified date: June 2024
• Source: University of Wisconsin, Madison
• Contact: Michael S Pulia, MD, PhD
• Phone: 608-262-2908
• Email: mpulia-lab[@]medicine.wisc.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: May 2026
• Est. primary completion date: May 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

Inclusion Criteria:

• Age = 65

• Clinically stable and able (not NPO) to safely drink water and eat a saltine cracker per ED provider

Exclusion Criteria:

• Prisoner

• Non-English speaking

Related Conditions & MeSH terms

• Deglutition Disorders
• Oropharyngeal Dysphagia

Intervention

Diagnostic Test:
• 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
• 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
• 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
• Test of Masticating and Swallowing Solids (TOMASS)
Measurement of bites, masticatory cycles, swallows, and time taken to consume a cracker
• 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)

Locations

Country	Name	City	State
United States	University of Wisconsin School of Medicine and Public Health	Madison	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
University of Wisconsin, Madison

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Positive oropharyngeal dysphagia screen prevalence	Number of participants with positive oropharyngeal dysphagia screen identified through bedside dysphagia screen and patient reported swallowing function	During emergency department visit, approximately 2-5 minutes for bedside dysphagia screen and 5-10 minutes for patient reported swallowing function
Secondary	Mean brief oral health status examination (BOHSE) score	Score 0 - 20 with 20 indicating the worst oral health	During emergency department visit, approximately 2-5 minutes
Secondary	Oral dryness prevalence	Number of participants with stimulated salivary flow rate (volume saliva/collection time) less than two standard deviations below published norms	During emergency department visit, up to 10 minutes for saliva collection
Secondary	Decreased tongue pressure prevalence	Number of participants with maximum isometric lingual pressures at front or back tongue location less than fifth percentile for published age-matched norms	During emergency department visit, approximately 2-5 minutes
Secondary	Decreased masticatory function prevalence	Number of participants with test of masticating and swallowing solids (TOMASS) greater than two standard deviations above published age- and sex-matched norms for any of four components: number of bites, number of masticatory cycles, number of swallows, total time	During emergency department visit, approximately 2-5 minutes
Secondary	pH of saliva sample	pH 0-14 of saliva as measured by digital pH meter	During emergency department visit, up to 10 minutes for saliva collection
Secondary	Extensional viscosity of saliva sample	Extensional viscosity of saliva as measured by an extensional rheometer	During emergency department visit, up to 10 minutes for saliva collection
Secondary	Salivary Substance P Concentration	Protein concentration (ng/mL) of Substance P in saliva	During emergency department visit, up to 10 minutes for saliva collection
Secondary	Oral microbiome	Comparison of microbial community composition in buccal mucosa, tongue dorsum, and saliva based on oral and swallowing function	During emergency department visit, up to 10 minutes for saliva collection
Secondary	Cell barrier function	Diffusion assays to quantify cell barrier function in bronchiole and blood vessel model after application of saliva to bronchiolar lumen	During emergency department visit, up to 10 minutes for saliva collection
Secondary	Protein composition	Multiplex bead-based ELISA to identify concentration (ng/mL) of proteins in bronchiole and blood vessel model after application of saliva to bronchiolar lumen	During emergency department visit, up to 10 minutes for saliva collection
Secondary	Gene expression	Quantification of gene expression in bronchiole and blood vessel model after application of saliva to bronchiolar lumen	During emergency department visit, up to 10 minutes for saliva collection
Secondary	Immunofluorescent staining	Quantification of immunofluorescent staining in bronchiole and blood vessel model after application of saliva to bronchiolar lumen	During emergency department visit, up to 10 minutes for saliva collection
Secondary	Immune cell trafficking	Quantification of immune cell trafficking in bronchiole and blood vessel model after application of saliva to bronchiolar lumen	During emergency department visit, up to 10 minutes for saliva collection