Oropharyngeal DysphagiaNCT04130867
Rehabilitation Manometry Study
An observational study of Oropharyngeal Dysphagia, run by University of Wisconsin, Madison at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Oropharyngeal Dysphagia
- What is being tested?
- pHRM and VFSS
- Type of treatment
- Surgery or procedure
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Nov 2020to 21 Apr 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 300 adults will be recruited to participate in the study. Participants will include 250 patients with heterogeneous causes of dysphagia undergoing active swallowing treatment and 50 age- and sex-match control participants with healthy swallow function. Participants will be stratified into the following goals of swallowing rehabilitation: Group A) Pharyngeal strengthening (n=125); and Group B) Relief of upper esophageal sphincter (UES) dysfunction or pharyngeal outlet obstruction (n=125). Classification will be based on clinician-driven diagnoses and treatment goals based on standard of care evaluation. The control group of healthy individuals will be Group C (n=50). Participants' age may range from 18-99 years old; as dysphagia is more frequent in the elderly, the sample will most likely include individuals age 60 and over.
Who may be able to join
- 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
Show all 10Show fewer
- 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.\
Who cannot join
- 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)
Show all 11Show fewer
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: Defining Novel Pharyngeal Pressure Metrics to Predict Dysphagia Treatment Outcomes and Clinical Prognosis Using High-resolution Manometry
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.
- Conditions
- Oropharyngeal Dysphagia
- Being tested
- pHRM, VFSS
- Medical subject headings
- Deglutition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pHRMProcedure or surgery
Pharyngeal high--resolution manometry (pHRM) provides direct and objective measurement of pressure changes in the pharynx that characterize basic mechanisms of swallowing.
VFSSProcedure or surgery
Videofluoroscopic Swallow Study (VFSS) enables real-time visualization of bolus flow during swallow movement.
| Study group | Role | What they receive |
|---|---|---|
| Group A: Swallow Therapy Oropharyngeal Strengthening | 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) Receives: Procedure: pHRM; Procedure: VFSS | |
| Group B: Surgical Treatment Esophageal Sphincter | 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) Receives: Procedure: pHRM; Procedure: VFSS | |
| Group C: Healthy Controls | Healthy controls (n=50) will also undergo data collection at parallel time points, without completion of a treatment paradigm. Receives: Procedure: pHRM; Procedure: VFSS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in pHRM from Baseline
pHRM data collected from the 250 adults undergoing dysphagia treatment and 50 healthy controls at three time points (baseline, mid-treatment, and post-treatment) will be used.
Measured: up to 3 months
Change in Sydney Swallowing Questionnaire between timepoints
The Sydney Swallowing Questionnaire is a 17-item inventory scored on a visual analog scale (VAS) (with the exception of Q12) developed to measure symptomatic severity of pharyngeal dysphagia. Each VAS is 100 mm, where the left side of the scale is lesser symptoms and the right hand of the scale is increased symptoms. Scoring is measured in distance (mm) from the left. Maximum range in the scoring is 0 - 1700, the higher the score, the more severe the symptoms.
Measured: baseline, mid-treatment 4-6 weeks, post-treatment 10-12 weeks
Change in Eat Assessment Tool Score between timepoints
The Eat Assessment Tool is a 10-item survey where each item is scored 0-4 where 0 is no problem and 4 is severe problem. The total range in score is 0-40 where higher scores indicate increased severity of symptoms.
Measured: baseline, mid-treatment 4-6 weeks, post-treatment 10-12 weeks
Change in Hand Grip Strength Test between timepoints
Participants will squeeze a dynamometer at maximum pressure 3 times and hold for 5 seconds each. 10 seconds rest will be given between each trial.
Measured: baseline, mid-treatment 4-6 weeks, post-treatment 10-12 weeks
Change in Maximum Isometric Pressure between timepoints
The Iowa Oral Pressure Instrument (IOPI) will be used to measure maximum isometric pressure. IOPI will be used to evaluate anterior and posterior maximal isometric tongue-pressures. A small (3.5 cm long and 4.5 cm in diameter) air-filled plastic pressure bulb will be placed in the mouth at two different positions: directly posterior to the incisors and at the posterior oral tongue. Participants will be asked to squeeze the bulb against the roof of the mouth with maximal effort and to perform saliva swallows. Three tasks in each position will be recorded and participants will rest for 10 seconds between each trial.
Measured: baseline, mid-treatment 4-6 weeks, post-treatment 10-12 weeks
Change in Dietary Assessment between timepoints
Participants will undergo diet assessment by using International Dysphagia Diet Standardisation Initiative Framework. This framework defines and scores food textures/consistencies for participants with dysphagia. Liquids are scored 0-4 where 0 is thin and 4 is extremely thick. Foods are scored from 3-7 where 3 is liquidized food and 7 is regular food.
Measured: baseline, mid-treatment 4-6 weeks, post-treatment 10-12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2019
- Study start11 Nov 2020
- Primary completion21 Apr 2021
- Study completion21 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oropharyngeal DysphagiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Timothy McCulloch, MD, FACS, Principal investigator, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04130867
- Sponsor's protocol ID
- 2019-0576
- Other IDs
- A539770, SMPH/SURGERY/SURGERY*OT, Protocol Ver 0.06, 1/16/2021
- Status last verified
- Oct 2025
- First submitted
- 15 Oct 2019
- Last updated
- 29 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Defining Novel Pharyngeal Pressure Metrics to Predict Dysphagia Treatment Outcomes and Clinical Prognosis Using High-resolution Manometry
- ClinicalTrials.gov ID
- NCT04130867
- Acronym / sponsor ID
- 2019-0576
- Conditions
- Oropharyngeal Dysphagia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 4 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Study start
- 11 Nov 2020 (actual)
- Primary completion
- 21 Apr 2021 (actual)
- Study completion
- 21 Apr 2021 (actual)
- First posted
- 18 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group A: Swallow Therapy Oropharyngeal Strengthening | – | Procedure: pHRM, Procedure: VFSSParticipants 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) |
| Group B: Surgical Treatment Esophageal Sphincter | – | Procedure: pHRM, Procedure: VFSSParticipants 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) |
| Group C: Healthy Controls | – | Procedure: pHRM, Procedure: VFSSHealthy controls (n=50) will also undergo data collection at parallel time points, without completion of a treatment paradigm. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 300 adults will be recruited to participate in the study. Participants will include 250 patients with heterogeneous causes of dysphagia undergoing active swallowing treatment and 50 age- and sex-match control participants with healthy swallow function. Participants will be stratified into the following goals of swallowing rehabilitation: Group A) Pharyngeal strengthening (n=125); and Group B) Relief of upper esophageal sphincter (UES) dysfunction or pharyngeal outlet obstruction (n=125). Classification will be based on clinician-driven diagnoses and treatment goals based on standard of care evaluation. The control group of healthy individuals will be Group C (n=50). Participants' age may range from 18-99 years old; as dysphagia is more frequent in the elderly, the sample will most likely include individuals age 60 and over.
Key inclusion criteria (10 listed)
- Pathological Group
- Normal Group
Key exclusion criteria (11 listed)
- Pathological Group
- Normal Group
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| pHRMPharyngeal high--resolution manometry (pHRM) provides direct and objective measurement of pressure changes in the pharynx that characterize basic mechanisms of swallowing. | Procedure or surgery | Group A: Swallow Therapy Oropharyngeal Strengthening, Group B: Surgical Treatment Esophageal Sphincter, Group C: Healthy Controls |
| VFSSVideofluoroscopic Swallow Study (VFSS) enables real-time visualization of bolus flow during swallow movement. | Procedure or surgery | Group A: Swallow Therapy Oropharyngeal Strengthening, Group B: Surgical Treatment Esophageal Sphincter, Group C: Healthy Controls |
Primary outcome
Change in pHRM from Baseline
Time frame: up to 3 months
pHRM data collected from the 250 adults undergoing dysphagia treatment and 50 healthy controls at three time points (baseline, mid-treatment, and post-treatment) will be used.
Change in Sydney Swallowing Questionnaire between timepoints
Time frame: baseline, mid-treatment 4-6 weeks, post-treatment 10-12 weeks
The Sydney Swallowing Questionnaire is a 17-item inventory scored on a visual analog scale (VAS) (with the exception of Q12) developed to measure symptomatic severity of pharyngeal dysphagia. Each VAS is 100 mm, where the left side of the scale is lesser symptoms and the right hand of the scale is increased symptoms. Scoring is measured in distance (mm) from the left. Maximum range in the scoring is 0 - 1700, the higher the score, the more severe the symptoms.
Change in Eat Assessment Tool Score between timepoints
Time frame: baseline, mid-treatment 4-6 weeks, post-treatment 10-12 weeks
The Eat Assessment Tool is a 10-item survey where each item is scored 0-4 where 0 is no problem and 4 is severe problem. The total range in score is 0-40 where higher scores indicate increased severity of symptoms.
Change in Hand Grip Strength Test between timepoints
Time frame: baseline, mid-treatment 4-6 weeks, post-treatment 10-12 weeks
Participants will squeeze a dynamometer at maximum pressure 3 times and hold for 5 seconds each. 10 seconds rest will be given between each trial.
Change in Maximum Isometric Pressure between timepoints
Time frame: baseline, mid-treatment 4-6 weeks, post-treatment 10-12 weeks
The Iowa Oral Pressure Instrument (IOPI) will be used to measure maximum isometric pressure. IOPI will be used to evaluate anterior and posterior maximal isometric tongue-pressures. A small (3.5 cm long and 4.5 cm in diameter) air-filled plastic pressure bulb will be placed in the mouth at two different positions: directly posterior to the incisors and at the posterior oral tongue. Participants will be asked to squeeze the bulb against the roof of the mouth with maximal effort and to perform saliva swallows. Three tasks in each position will be recorded and participants will rest for 10 seconds between each trial.
Change in Dietary Assessment between timepoints
Time frame: baseline, mid-treatment 4-6 weeks, post-treatment 10-12 weeks
Participants will undergo diet assessment by using International Dysphagia Diet Standardisation Initiative Framework. This framework defines and scores food textures/consistencies for participants with dysphagia. Liquids are scored 0-4 where 0 is thin and 4 is extremely thick. Foods are scored from 3-7 where 3 is liquidized food and 7 is regular food.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2025.
- Individual participant dataSharing planned: No
Related trials for Oropharyngeal Dysphagia
RecruitingObservational study
Effect of Thickened Feeds on Clinical Outcomes in Children With Brief Resolved Unexplained Event
Brief Resolved Unexplained Event, Apparent Life Threatening Event
RecruitingPhase 2
Wearable Biofeedback for Swallowing Disorders Rehabilitation in Stroke and Parkinson Disease
Dysphagia, Stroke
Recruiting
K01 Impacts of Lingual Endurance Exercise
Dysphagia, Dysphagia, Oropharyngeal
RecruitingPhase 2
Adaptive RadioTherapy for OroPharynx Cancer
Oropharynx Cancer, Radiotherapy; Complications
Recruiting
Tongue-strengthening Exercises in People With ALS.
ALS (Amyotrophic Lateral Sclerosis), ALS - Amyotrophic Lateral Sclerosis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Timothy McCulloch, MD, FACS principal investigator
University of Wisconsin, Madison
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Oropharyngeal Dysphagia, run by University of Wisconsin, Madison at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in pHRM from Baseline (time frame: up to 3 months). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2025.