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Novel Pharyngeal Metrics to Predict Dysphagia Outcomes

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

Tracking Information
First Submitted Date  ICMJE September 23, 2020
First Posted Date  ICMJE September 29, 2020
Last Update Posted Date September 8, 2022
Actual Study Start Date  ICMJE June 28, 2021
Estimated Primary Completion Date March 29, 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (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  ICMJE
 (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.
Change History
Current Secondary Outcome Measures  ICMJE
 (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  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Novel Pharyngeal Metrics to Predict Dysphagia Outcomes
Official Title  ICMJE 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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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  ICMJE
  • Dysphagia
  • Swallowing Disorders
Intervention  ICMJE Other: standard of care lingual strengthening
standard or care lingual strengthening approaches with outcome measured with novel pressure metrics
Study Arms  ICMJE
  • Experimental: Patient group
    lingual strengthening
    Intervention: Other: standard of care lingual strengthening
  • No Intervention: Healthy controls
    Healthy normal swallow
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: September 23, 2020)
200
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 30, 2025
Estimated Primary Completion Date March 29, 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 99 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
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  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04569097
Other Study ID Numbers  ICMJE 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  ICMJE
Plan to Share IPD: No
Current Responsible Party VA Office of Research and Development
Original Responsible Party Same as current
Current Study Sponsor  ICMJE VA Office of Research and Development
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
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

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP