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Completed

NCT Number: NCT04569097

Novel Pharyngeal Metrics to Predict Dysphagia Outcomes

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.

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Key information

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Edward Hines Jr. VA Hospital, Hines, IL, Hines, Illinois, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

standard of care lingual strengthening

Other

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

Primary outcomes

  1. pHRM Pressure Change (Pharyngeal)

    Time frame: Baseline and 8 weeks

    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:

    • 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).
  2. pHRM Pressure Change (Mesopharyngeal)

    Time frame: Baseline and 8 weeks

    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:

    • 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).
  3. Swallowing Clinical and Fluoroscopic Change (MBSImP)

    Time frame: Baseline and 8 weeks

    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.

  4. Patient Reported Outcome Changes (SSQ)

    Time frame: Baseline and 8 weeks

    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.

Secondary outcomes

  1. Patient Reported Outcome Changes (EAT-10)

    Time frame: Baseline and 8 weeks

    The Eating Assessment Tool-10 (EAT-10) is a short 10 question swallowing assessment tool with 10 questions each scaled 0 to 4, total can be between 0 and 40. The normal swallowers will score under 2. Changes toward 0 will be identified as improved swallow symptom function, changes toward 40 worsening symptoms.

  2. Patient Reported Outcome Changes, Diet Change

    Time frame: Baseline, 4 weeks, and 8 weeks

    International Dysphagia Diet Standardization initiative, Functional Oral Intake 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 thick 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.

Sponsors and collaborators

Lead sponsor

VA Office of Research and Development

Fed

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Sep 29, 2020
Registry last updated
May 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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