Oral and Swallowing Function in Older Adults

NCT06368830 | Recruiting

• 3 other identifiers: 2024-0337A534100Protocol Version 10/22/25
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Oropharyngeal Dysphagia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (13)

• Mean brief oral health status examination (BOHSE) score

  During emergency department visit, approximately 2-5 minutes

• Oral dryness prevalence

  During emergency department visit, up to 10 minutes for saliva collection

• Decreased tongue pressure prevalence

  During emergency department visit, approximately 2-5 minutes

• Decreased masticatory function prevalence

  During emergency department visit, approximately 2-5 minutes

• pH of saliva sample

  During emergency department visit, up to 10 minutes for saliva collection

Interventions

3-ounce water swallow test DIAGNOSTIC_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) DIAGNOSTIC_TEST

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 DIAGNOSTIC_TEST

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) DIAGNOSTIC_TEST

Measurement of bites, masticatory cycles, swallows, and time taken to consume a cracker

Respiratory function tests DIAGNOSTIC_TEST

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)

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Older adults presenting to the emergency department

You may qualify if:

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

You may not qualify if:

• Prisoner
• Non-English speaking

Sponsors & Collaborators

• University of Wisconsin, Madison: lead

Study Sites (1)

University of Wisconsin School of Medicine and Public Health

Madison, Wisconsin, 53792, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Saliva samples will be retained and human DNA sequences will not be collected from the saliva samples.

MeSH Terms

Conditions

Deglutition Disorders

Interventions

Respiratory Function Tests

Condition Hierarchy (Ancestors)

Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Respiratory System; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Michael S Pulia, MD, PhD

  University of Wisconsin, Madison

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Michael S Pulia, MD, PhD

CONTACT

608-262-2908; mpulia-lab@medicine.wisc.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 10, 2024
• First Posted: April 16, 2024
• Study Start: June 3, 2024
• Primary Completion: May 1, 2026
• Study Completion: May 1, 2026
• Last Updated: November 5, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: Beginning 9 months after publication of primary outcomes and ending 5 years after that date.
• Access Criteria: Proposals should be directed to Dr. Michael Pulia at mpulia-lab@medicine.wisc.edu. If approved after review by regulatory counsel, requestors will enter into a formal data sharing agreement. Data will be shared via encrypted single-user file transmission protocol.

Locations

US (1)