Measuring swallowing function in patients with dysphagia

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

This study is testing if a new way to measure swallowing can help people with swallowing difficulties understand their treatment progress and predict how well their treatments will work.

Quick facts

• Study type: Observational
• Enrollment: 300 (estimated)
• Ages: 18 Years to 99 Years
• Sex: All
• Sponsor: University of Wisconsin, Madison (other)
• Locations: 1 site (Madison, Wisconsin)
• Trial ID: NCT04130867 on ClinicalTrials.gov

What this trial studies

This observational study focuses on patients with oropharyngeal dysphagia, a condition that significantly impacts the ability to swallow. It utilizes pharyngeal high-resolution manometry (pHRM) to objectively measure swallowing pressures and assess treatment outcomes. The study aims to determine if these objective measures correlate with patient-reported outcomes and can predict treatment benefits. Participants will undergo swallowing assessments as part of their treatment plans, which may include therapies to strengthen swallowing muscles or relieve obstructions.

Who should consider this trial

Good fit: Ideal candidates include adults diagnosed with oropharyngeal dysphagia who have a treatment plan focused on strengthening swallowing muscles or relieving obstructions.

Not a fit: Patients who have already initiated a therapeutic management plan for dysphagia may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could enhance the understanding and treatment of dysphagia, leading to improved patient outcomes.

How similar studies have performed: While the use of pHRM in dysphagia treatment is promising, this specific approach to measuring treatment outcomes is relatively novel and has not been extensively tested in prior studies.

Eligibility criteria

Inclusion Criteria:

* Pathological Group

  * Must have dysphagia as diagnosed by a licensed and certified otolaryngologist, gastroenterologist, or speech-language pathologist AND must have a dysphagia treatment plan that includes one of the following primary goals:

    * Therapy to strengthen oropharyngeal musculature
    * Medical or surgical management to relieve an obstruction at the upper esophageal sphincter
  * Must agree to comply with swallowing assessment, including interview and manometry
  * Must sign the Informed Consent form approved by the Health Sciences Institutional Review Board of the University of Wisconsin
* Normal Group

  * Having no swallowing disorders
  * Must agree to comply with swallowing assessment, including interview and manometry
  * Must sign the Informed Consent form approved by the Health Sciences Institutional Review Board of the University of Wisconsin.\\

Exclusion Criteria:

* Pathological Group

  * Therapeutic management plan already initiated prior to recruitment
  * Therapy goals including only improvement of swallowing coordination
  * Developmental disability, dementia, cognitive dysfunction, or difficulty comprehending instructions
  * Positive history of allergic response to topical anesthetic
  * Allergy to food relevant to study participation (e.g. lactose intolerance)
* Normal Group

  * Known swallowing disorder
  * Developmental disability, dementia, cognitive dysfunction, or difficulty comprehending instructions
  * Positive history of allergic response to topical anesthetic
  * Allergy to food relevant to study participation (e.g. lactose intolerance)

Where this trial is running

Madison, Wisconsin

• University of Wisconsin — Madison, Wisconsin, United States (RECRUITING)

Study contacts

• Principal investigator: Timothy McCulloch, MD, FACS — University of Wisconsin, Madison
• Study coordinator: Suzan Abdelhalim, MD, MPH

Conditions: Oropharyngeal Dysphagia