Novel Pharyngeal Metrics to Predict Dysphagia Outcomes

• ClinicalTrials.gov Identifier: NCT04569097
• Recruitment Status: Recruiting
• First Posted: September 29, 2020
• Last Update Posted: September 8, 2022
• Sponsor: VA Office of Research and Development
• Information provided by (Responsible Party): VA Office of Research and Development

Tracking Information

• First Submitted Date: September 23, 2020
• First Posted Date: September 29, 2020
• Last Update Posted Date: September 8, 2022
• Actual Study Start Date: June 28, 2021
• Estimated Primary Completion Date: March 29, 2024 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: March 19, 2021)

• pHRM pressure change [ Time Frame: Baseline, 4 weeks, 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 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)
• Swallowing clinical and fluoroscopic change [ Time Frame: Baseline, 4 weeks, 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 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
• Patient reported outcome changes [ Time Frame: Baseline, 4 weeks, and 8 weeks ]
  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.

Original Primary Outcome Measures (submitted: September 23, 2020)

• pHRM pressure change [ Time Frame: Baseline, 4 weeks, 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 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)
• Swallowing clinical and fliuoroscopic change [ Time Frame: Baseline, 4 weeks, 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 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
• Patient reported outcome changes [ Time Frame: Baseline, 4 weeks, and 8 weeks ]
  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.

Current Secondary Outcome Measures (submitted: September 23, 2020)

• Patient reported outcome changes [ Time Frame: Baseline, 4 weeks, and 8 weeks ]
  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
• Patient reported outcome changes, Diet change [ Time Frame: Baseline, 4 weeks, and 8 weeks ]
  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

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Novel Pharyngeal Metrics to Predict Dysphagia Outcomes
• Official Title: Defining Novel Pharyngeal Pressure Metrics to Predict Dysphagia Treatment Outcomes and Clinical Prognosis Using High-resolution Manometry

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.

• 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
• Study Phase: Not Applicable

Study Design

Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

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.

Masking: Single (Outcomes Assessor)
Primary Purpose: Diagnostic

Condition

• Dysphagia
• Swallowing Disorders

Intervention

Other: standard of care lingual strengthening

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

Study Arms

• Experimental: Patient group
  lingual strengthening
  Intervention: Other: standard of care lingual strengthening
• No Intervention: Healthy controls
  Healthy normal swallow

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: September 23, 2020): 200
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: September 30, 2025
• Estimated Primary Completion Date: March 29, 2024 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 99 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Contacts

Contact: Aaron F Heneghan, PhD; (608) 256-1901 ext 17801; Aaron.Heneghan@va.gov

Contact: Jenna W Quinto, PhD; (680) 256-1901 ext 17865; jenna.quinto@va.gov

• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT04569097
• Other Study ID Numbers: N3221-R
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• 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

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: VA Office of Research and Development
• Original Responsible Party: Same as current
• Current Study Sponsor: VA Office of Research and Development
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Timothy M. McCulloch, MD; William S. Middleton Memorial Veterans Hospital, Madison, WI

• PRS Account: VA Office of Research and Development
• Verification Date: September 2022