Novel Pharyngeal Metrics to Predict Dysphagia Outcomes

Defining Novel Pharyngeal Pressure Metrics to Predict Dysphagia Treatment Outcomes and Clinical Prognosis Using High-resolution Manometry

This multi-site trial will follow a cohort of Veterans with dysphagia for 8 weeks as they undergo clinically guided oropharyngeal exercises with oropharyngeal strengthening as the primary goal. Veterans with dysphagia will be assessed at three time points: baseline, 4 weeks after treatment initiation, and 8 weeks after treatment initiation. A non-dysphagic Veteran control group will also undergo data collection at parallel time points, without completion of a treatment paradigm. The investigators will then compare patients to non-dysphagic controls using manometry, videofluoroscopy, diet assessment, functional reserve tests, and patient-reported outcome measures.

The investigators aim to 1) quantify change in pressure measures of swallowing function resulting from dysphagia treatment; 2) determine which combination of standard of care and/or pressure-based metrics best track with outcome measures; and 3) develop multimodal prognostic algorithms that predict treatment success. This research will establish a precise outcome measurement paradigm suitable for dysphagia clinical care and research, thus improving clinical confidence and paving the way for a personalized medicine approach for dysphagia rehabilitation in Veterans.

Study Overview

• Status: Recruiting
• Conditions: Dysphagia; Swallowing Disorders
• Intervention / Treatment: Other: standard of care lingual strengthening

Detailed Description

This multi-center trial will follow a cohort of Veterans with dysphagia for 8 weeks as they undergo clinically guided oropharyngeal exercises with oropharyngeal strengthening as the primary goal. Veterans with dysphagia will be assessed at three time points: baseline, 6-4 weeks post-treatment, and 8 weeks post-treatment. A non-dysphagic Veteran control group (n=50) will also undergo data collection at parallel time points, without completion of a treatment paradigm. The investigators will then compare patients to nondysphagic controls using pHRM, videofluoroscopy, diet assessment, functional reserve tests, and patient reported outcome measures. The investigators aim to 1) quantify change in pHRM measures of swallowing function resulting from dysphagia treatment; 2) determine which combination of standard of care and/or pHRM-based metrics best track with patient-reported outcome measures; and 3) develop multimodal prognostic algorithms that predict treatment success. This research will establish a precise outcome measurement paradigm suitable for dysphagia clinical care and research, thus improving clinical confidence and paving the way for a personalized medicine approach for dysphagia rehabilitation in Veterans.

• Study Type: Interventional
• Enrollment (Estimated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Aaron F Heneghan, PhD; Phone Number: 17801 (608) 256-1901; Email: Aaron.Heneghan@va.gov
• Study Contact Backup: Name: Jenna W Quinto, PhD; Phone Number: 17865 (680) 256-1901; Email: jenna.quinto@va.gov

Study Locations

• United States
  • Illinois
    • Hines, Illinois, United States, 60141-3030
      • Recruiting
      • Edward Hines Jr. VA Hospital, Hines, IL
      • Contact: Laura Chalcraft, MS; Phone Number: 708-202-4934; Email: laura.chalcraft@va.gov
  • Ohio
    • Cincinnati, Ohio, United States, 45220-2213
      • Recruiting
      • Cincinnati VA Medical Center, Cincinnati, OH
      • Contact: Kathy Welden, PhD; Phone Number: 5226 513-861-3100; Email: kathy.welden@va.gov
  • Wisconsin
    • Madison, Wisconsin, United States, 53705-2254
      • Recruiting
      • William S. Middleton Memorial Veterans Hospital, Madison, WI
      • Contact: Aaron F Heneghan, PhD; Phone Number: 17801 608-256-1901; Email: Aaron.Heneghan@va.gov
      • Contact: Jenna W Quinto, PhD; Phone Number: 17865 (680) 256-1901; Email: jenna.quinto@va.gov
      • Principal Investigator: Timothy M. McCulloch, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 97 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Signed an informed consent form
• Receive a dysphagia diagnosis by a speech-language pathologist
• Must have a dysphagia treatment plan with the goal of strengthening the oropharyngeal musculature
• English speaking

Exclusion Criteria:

• history of allergic response to barium
• history of allergic response to topical anesthetics

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Patient group; lingual strengthening	Other: standard of care lingual strengthening; standard or care lingual strengthening approaches with outcome measured with novel pressure metrics
No Intervention: Controls; No history of dysphagia (swallowing disorder) or minimal to mild dysphagia not requiring a strengthening program

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
pHRM pressure change	Will assess the change in pressure by pharyngeal high resolution manometry over the time frame The primary measure of interest is Integral Pressure during the 10 mL swallow at the tongue base Range is From: 0 mmHg*sec, no pressure recorded to up to 250 mmHg*sec., very high pressures recorded, normal range is age and sex dependent Range (114+/-50 to167 +/-80) Positive change would be a movement toward normal range of pressure. This metric is measured automatically in both Software systems used to evaluate pharyngeal pressure (WiscMano and Swallow gateway)	Baseline, 4 weeks, and 8 weeks
Swallowing clinical and fluoroscopic change	Will assess the change in fluoroscopy and clinical assessments over the time frame The primary tool of measurement is the combined score of the MBSImP this is a 17 item standardized tool to measure impairment of swallow identified using contrast barium swallows. We will use the composite pharyngeal score which ranges from 0 to 3, the higher the score the more abnormal the swallow function, Normal swallows will score 5 or less and severe dysphagia will score 9 or higher. Movement toward 0 is a positive or improved swallow function, movement toward 23 is negative or worsening swallow function	Baseline, 4 weeks, and 8 weeks
Patient reported outcome changes	Sydney swallowing questionnaire (SSQ) The SSQ is a patient reported symptom scale with 17 questions, each scaled from 0+ no dysfunction to 100 equal extreme dysfunction using a 100mm visual analogue scale with 0 and 100 as anchors. the total score can be recorded for 0 to 1700, Normal swallowers will average 40 with a range of 200 to 0, Dysphagia patients average 800 with a range of 150 to 1600. Movement toward 0 will be considered an improvement, movement toward 1700 worsening in swallowing ability preserved by the patient.	Baseline, 4 weeks, and 8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient reported outcome changes	Eating assessment tool -10, The Eat 10 is a short 10 question swallowing assessment tool 10 questions each scaled 0 to 4, total can be between 0 and 40. The normal swallowers will score under 2. The mean (+/- SD) EAT-10 score of the normal cohort was 0.40 +/- 1.01. The mean EAT-10 score for those with oropharyngeal dysphagia, 23.10 +/- 12.22 Changes toward 0 will be identified as improved swallow symptom function, changes toward 40 worsening symptoms	Baseline, 4 weeks, and 8 weeks
Patient reported outcome changes, Diet change	International Dysphagia Diet Standardization initiative, Functional Oral intact scale Standardize scale of diet (liquid and solid food) iddsi.org foods scaled from regular diet 7 to liquidized 3, and liquids scaled from thin liquids 0 to extremely think 4 Improvement in diet will be report if patients move toward 0 in liquid intake and toward 7 in solid food intact and movement in the opposite directions will be evidence of poorly food and liquid tolerance	Baseline, 4 weeks, and 8 weeks

Collaborators and Investigators

• Sponsor: VA Office of Research and Development
• Investigators: Principal Investigator: Timothy M. McCulloch, MD, William S. Middleton Memorial Veterans Hospital, Madison, WI

Study record dates

Study Major Dates

• Study Start (Actual): June 28, 2021
• Primary Completion (Estimated): March 29, 2024
• Study Completion (Estimated): September 30, 2025

Study Registration Dates

• First Submitted: September 23, 2020
• First Submitted That Met QC Criteria: September 23, 2020
• First Posted (Actual): September 29, 2020

Study Record Updates

• Last Update Posted (Actual): August 23, 2023
• Last Update Submitted That Met QC Criteria: August 18, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: veterans; dysphagia; swallowing; manometry
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases; Esophageal Diseases; Deglutition Disorders
• Other Study ID Numbers: N3221-R

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No