Rehabilitation Manometry Study

University of Wisconsin (UW)

Status: Completed

Conditions: Oropharyngeal Dysphagia

Treatments: Procedure: VFSS; Procedure: pHRM

Study type: Observational

Funder types: Other

Identifiers

NCT04130867

2019-0576

SMPH/SURGERY/SURGERY*OT (Other Identifier)

Protocol Ver 0.06, 1/16/2021 (Other Identifier)

A539770 (Other Identifier)

Details and patient eligibility

About

Oropharyngeal dysphagia, or difficulty swallowing, is a devastating condition that affects physiological and psychosocial functioning in 1 in 25 adults. Many dysphagia treatments exist, but our ability to adequately measure treatment outcomes is limited. Pharyngeal high-resolution manometry (pHRM) directly measures swallowing pressures, providing an objective measurement of physiology that characterizes the basic mechanisms of swallowing. pHRM is well-poised to measure outcomes of dysphagia treatments due to its direct, objective, and reproducible measures of swallowing function.

This proposed project will address a central hypotheses that objective swallowing measures (including (pHRM) will reveal treatment-mediated swallowing changes, will align with patient-reported outcome measures, and will be able to predict who will benefit from treatment. The investigators will follow a cohort of participants with oropharyngeal dysphagia as they undergo either pharyngeal strengthening therapy or relief of upper esophageal sphincter outlet obstruction at three time points: baseline, mid-treatment (4-6 weeks) and post-treatment (10-12 weeks). The investigators will compare participants to healthy controls using pHRM, videofluoroscopy, diet assessment, functional reserve tests, and patient-reported outcome measures.

Enrollment: 4 patients

Sex: All

Ages: 18 to 99 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

4 participants in 3 patient groups

Group A: Swallow Therapy Oropharyngeal Strengthening

Description:

Participants receiving any standard of care swallow therapy with oropharyngeal strengthening as the primary goal Participants will undergo pHRM, videofluoroscopy (VF), diet assessment, functional reserve tests, and patient--reported outcome questionnaires at 3 standardized time points: baseline, 4 to 6 weeks (mid therapy), and 10 to -12 weeks (post -therapy)

Treatment:

Procedure: pHRM

Procedure: VFSS

Group B: Surgical Treatment Esophageal Sphincter

Description:

Participants receiving surgical treatment for relief of upper esophageal sphincter outlet obstruction. Participants will undergo pHRM, videofluoroscopy (VF), diet assessment, functional reserve tests, and patient--reported outcome questionnaires at 3 standardized time points: baseline, 4 to 6 weeks (mid therapy), and 10 to -12 weeks (post therapy)

Treatment:

Procedure: pHRM

Procedure: VFSS

Group C: Healthy Controls

Description:

Healthy controls (n=50) will also undergo data collection at parallel time points, without completion of a treatment paradigm.

Treatment:

Procedure: pHRM

Procedure: VFSS