Novel Pharyngeal Metrics to Predict Dysphagia Outcomes

NCT04569097 | Completed Results

• 1 other identifier: N3221-R
• Study Type: interventional
• Target: 227
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

Dysphagia; Swallowing Disorders

Keywords

dysphagia; manometry; swallowing; veterans

Outcome Measures

Primary Outcomes (4)

• pHRM Pressure Change (Pharyngeal)

  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. This is measured in two forms: 1\. Pharyngeal Contractile Integral (PhCI): range is between 100 and 600 mmHg·s·cm ; 2. Mesopharyngeal Max Pressure (tongue base): range is between \~115-210 mmHg in healthy adults. 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 and 8 weeks

• pHRM Pressure Change (Mesopharyngeal)

  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. This is measured in two forms: 1\. Pharyngeal Contractile Integral (PhCI): range is between 100 and 600 mmHg·s·cm ; 2. Mesopharyngeal Max Pressure (tongue base): range is between \~115-210 mmHg in healthy adults. 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 and 8 weeks

• Swallowing Clinical and Fluoroscopic Change (MBSImP)

  Will assess the change in fluoroscopy and clinical assessments over the time frame. The primary tool of measurement is the combined score of the Modified Barium Swallow Impairment Profile (MBSImP). This is a 17 item standardized tool to measure impairment of swallow identified using contrast barium swallows. The investigators 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 and full range is from 0 to 29 with a higher score indicating worse impairment. Scores under 13 indicate the mild or no impairment.

  Baseline and 8 weeks

• Patient Reported Outcome Changes (SSQ)

  The Sydney Swallowing Questionnaire (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 and 8 weeks

Secondary Outcomes (2)

• Patient Reported Outcome Changes (EAT-10)

  Baseline and 8 weeks

• Patient Reported Outcome Changes, Diet Change

  Baseline, 4 weeks, and 8 weeks

Study Arms (2)

Patient group

EXPERIMENTAL

lingual strengthening

Other: standard of care lingual strengthening

Controls

NO INTERVENTION

No history of dysphagia (swallowing disorder) or minimal to mild dysphagia not requiring a strengthening program

Interventions

standard of care lingual strengthening OTHER

standard or care lingual strengthening approaches with outcome measured with novel pressure metrics

Patient group

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (3)

Edward Hines Jr. VA Hospital, Hines, IL

Hines, Illinois, 60141-3030, United States

Location

Cincinnati VA Medical Center, Cincinnati, OH

Cincinnati, Ohio, 45220-2213, United States

Location

William S. Middleton Memorial Veterans Hospital, Madison, WI

Madison, Wisconsin, 53705-2254, United States

Location

MeSH Terms

Conditions

Deglutition Disorders

Condition Hierarchy (Ancestors)

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

Limitations and Caveats

Earlier in the study we encountered more subject withdrawals due to manometry catheter placement discomfort. We have addressed the issue with the use of atomized lidocaine and oxymetazoline at two of our sites. Delays in procurement of the saline. COVID 19 pandemic affected recruitment. Research Coordinators turn over. Travel restrictions due to COVID 19 delayed manometry training in the other two sites. A delay to establish new process to pay Dep of Radiology this led to delay in Controls

Results Point of Contact

• Title: Suzan Abdelhalim
• Organization: VDORD or local VA medical center

Suzan.abdelhalim@va.gov

608-268-1901

Study Officials

• Timothy M. McCulloch, MD

  William S. Middleton Memorial Veterans Hospital, Madison, WI

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: Patients will be stratified into the following groups: Group A) Patient Group receiving Pharyngeal strengthening (n=150); and Group B) Healthy Controls (n=50). Participants' age may range from 18-99 years old, however, the investigators expect most study participants will be \>60 years old due to the age range typically affected by dysphagia.

Study Record Dates

• First Submitted: September 23, 2020
• First Posted: September 29, 2020
• Study Start: June 28, 2021
• Primary Completion: September 30, 2024
• Study Completion: September 30, 2024
• Last Updated: May 11, 2026
• Results First Posted: May 11, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)