DysphagiaNCT05708911
External Pharyngeal Exerciser and Pharyngeal Phase of Swallowing
A study testing Pharyngeal exerciser in people with Dysphagia, run by Medical College of Wisconsin at 1 site in United States.
Trial summary
This study of healthy young and elderly individuals is intended to assess the effects of pharyngeal exerciser on pharyngeal pressure phenomenon during swallowing. Our specific aim is to test if the pharyngeal exerciser increases the workload of muscles involved in pharyngeal phase of swallowing. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Dysphagia
- What is being tested?
- Pharyngeal exerciser
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Sep 2014to 30 Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy volunteers must be at least 18 years of age or older.
Who cannot join
- Subjects with cervical spine disorders.
- Subjects with neurological disorders like dementia, cerebrovascular diseases other than Parkinson's Disease
- Subjects with carotid artery bruit or carotid vascular disorders.
- Subjects suffering from muscle diseases like muscular dystrophies, myopathies.
- Subjects with neuro-muscular junction disorders myasthenia gravis, Eaton-Lambert disorders.
- Subjects with any current esophageal symptoms like heartburn, dysphagia, chest pain or regurgitation.
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- Subjects cannot have previous head or neck surgery or radiation.
- Subjects unable to tolerate nasal intubation.
- Subjects with significant bleeding disorders for whom nasal intubation has been deemed contraindicated.
- Subjects with a known upper airway or esophageal obstruction preventing the passage of the manometry probe.
- Subjects with autonomic dysfunction.
- Subjects having a history of allergy to lidocaine and barium.
- Subjects who are pregnant or lactating.
- Subjects who have advanced medical disorders (e.g.: chronic obstructive pulmonary disease (COPD), congestive heart failure, cirrhosis, cancer, chronic renal failure, etc.).
- Subjects who are medically unstable.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Medical College of Wisconsin
Milwaukee, Wisconsin, 53086
Reza Shaker, MD, 4149556840, rshaker@mcw.edu
Mark Kern, 4148053826, mkern@mcw.edu
About this study
Official title: Impact of External Pharyngeal Exerciser on Pharyngeal Phase of Swallowing
This study of healthy young and elderly individuals is intended to assess the effects of pharyngeal exerciser on pharyngeal pressure phenomenon during swallowing. Our specific aim is to test if the pharyngeal exerciser increases the workload of muscles involved in pharyngeal phase of swallowing.
Read the detailed description
- All the study subjects are required to be without oral food or fluid intake for at least 3 hours prior to the study.
- The participant's neck's physical dimensions and the device's physical dimensions will be measured and recorded. A physical examination including carotid artery auscultation will be performed.
- After the application of local lidocaine, the high-resolution manometry (HRM) catheter will be inserted through the more patent nares and positioned such that it covers the entire pharynx from the nasopharynx to the proximal esophagus. In this position, manometry recording of the entire pharynx will be possible.
- The pharyngeal exerciser will be placed around the neck overlying the larynx. The device will be in contact with the skin without any underlying pressure using the Velcro fastening in the back of the neck.
- Patients will be sitting in an upright position and acclimatized for 10 minutes before proceeding.
- Each subject will perform the following swallows:
- Dry swallows x 5 times.
5 ml and 10 ml- of water swallows at room temperature x 5 times each.
5 ml and 10 ml- mashed potato swallowed at room temperature x 5 times each.
- The sequence of the swallow types will be randomized. The swallow will be performed under device pressure of zero, 20, 30, 40 and 60 mm Hg in a randomized fashion. Each swallow type will be repeated 5 times with 30-second intervals in between.
- The externally applied pressure will be measured by means of the pressure gauge included in the device
- All the subjects will be given the option to participate in the concurrent videofluoroscopic examination along with pharyngeal manometry
- The fluoroscopy machine will be turned "on" for 5 seconds only during the swallowing. The rest of the time fluoroscopy machine will be turned off.
- These subjects undergoing concurrent fluoroscopy and manometry will perform the following swallows at zero, 20, and 40 mm Hg of device pressure:
Dry swallows x 3 times.
5 ml and 10 ml of water mixed barium swallow at room temperature x 3 times each.
5 ml- mashed potatoes mixed with barium at room temperature x 3 times.
The participant will also be instructed to resume their regular diet and activity.
All the tracings and video recordings will be analyzed by two individuals in a blinded fashion.
- Conditions
- Dysphagia
- Being tested
- Pharyngeal exerciser
- Medical subject headings
- Deglutition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pharyngeal exerciserDevice
Pharyngo-esophageal manometry during lateral fluoroscopy
| Study group | Role | What they receive |
|---|---|---|
| Pharyngeal exerciser group | Experimental | Test that application of the pharyngeal exerciser increases the workload of muscles involved in pharyngeal phase of swallowing as evidenced manometrically by changes in
Pharyngeal peak pressures Pharyngeal (velopharynx, oropharynx and hypopharynx) contractile duration Pharyngeal (velopharynx, oropharynx and hypopharynx) contractile integral Hypopharyngeal intrabolus pressure and duration UES nadir pressure UES relaxation time Baseline UES pressure Receives: Device: Pharyngeal exerciser |
What is being measured
The primary outcome is the main question the study is designed to answer.
laryngeal excursion during swallowing
maximum laryngeal excursion from resting position measured from fluoroscopic images during swallowing
Measured: During mano-fluorography procedure
hyoid excursion during swallowing
maximum hyoid bone excursion from resting position measured from fluoroscopic images during swallowing
Measured: During mano-fluorography procedure
upper esophageal sphincter (UES) opening during swallowing
maximum UES anterior-posterior diameter measured from fluoroscopic images during swallowing
Measured: During mano-fluorography procedure
pharyngeal peak peristaltic pressure
maximum deglutitive pressure within the pharynx
Measured: During mano-fluorography procedure
pharyngeal (velopharynx, oropharynx and hypopharynx) contractile duration
manometric duration of peristaltic pressure wave in velopharynx, oropharynx and hypopharynx
Measured: During mano-fluorography procedure
pharyngeal (velopharynx, oropharynx and hypopharynx) contractile integral
space-time and length integral of pharyngeal pressures in the velopharynx, oropharynx and hypopharynx
Measured: During mano-fluorography procedure
hypopharyngeal intrabolus pressure
maximum pressure within the hypopharynx as the swallowed bolus covers the pressure sites within the hypopharynx
Measured: During mano-fluorography procedure
hypopharyngeal intrabolus duration
duration of maximum pressure within the hypopharynx as the swallowed bolus covers the pressure sites within the hypopharynx
Measured: During mano-fluorography procedure
UES nadir pressure
minimum pressure within the upper esophageal sphincter (UES) during UES deglutitive relaxation
Measured: During mano-fluorography procedure
UES relaxation time
duration pressure drops within the upper esophageal sphincter during UES deglutitive relaxation
Measured: During mano-fluorography procedure
baseline UES pressure
average UES pressure when no swallow activity is present
Measured: During mano-fluorography procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2023
- Study start16 Sep 2014
- Primary completion30 Sep 2026 (estimated)
- Study completion30 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DysphagiaStudies of the same condition, open and under way.
- More trials run by Medical College of WisconsinThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Study of healthy subjects
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical College of Wisconsin
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Reza Shaker, MD, Medical College of Wisconsin
- Investigators
- Reza Shaker, MD, Principal investigator, Medical College of Wisconsin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05708911
- Sponsor's protocol ID
- PRO00022959
- Status last verified
- Jan 2026
- First submitted
- 13 Jan 2023
- Last updated
- 14 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of External Pharyngeal Exerciser on Pharyngeal Phase of Swallowing
- ClinicalTrials.gov ID
- NCT05708911
- Acronym / sponsor ID
- PRO00022959
- Conditions
- Dysphagia
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Medical College of WisconsinUniversity, hospital or other
- Study start
- 16 Sep 2014 (actual)
- Primary completion
- 30 Sep 2026 (estimated)
- Study completion
- 30 Sep 2026 (estimated)
- First posted
- 1 Feb 2023 (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.
This study of healthy young and elderly individuals is intended to assess the effects of pharyngeal exerciser on pharyngeal pressure phenomenon during swallowing. Our specific aim is to test if the pharyngeal exerciser increases the workload of muscles involved in pharyngeal phase of swallowing.
Detailed description
- All the study subjects are required to be without oral food or fluid intake for at least 3 hours prior to the study.
- The participant's neck's physical dimensions and the device's physical dimensions will be measured and recorded. A physical examination including carotid artery auscultation will be performed.
- After the application of local lidocaine, the high-resolution manometry (HRM) catheter will be inserted through the more patent nares and positioned such that it covers the entire pharynx from the nasopharynx to the proximal esophagus. In this position, manometry recording of the entire pharynx will be possible.
- The pharyngeal exerciser will be placed around the neck overlying the larynx. The device will be in contact with the skin without any underlying pressure using the Velcro fastening in the back of the neck.
- Patients will be sitting in an upright position and acclimatized for 10 minutes before proceeding.
- Each subject will perform the following swallows:
- Dry swallows x 5 times.
5 ml and 10 ml- of water swallows at room temperature x 5 times each.
5 ml and 10 ml- mashed potato swallowed at room temperature x 5 times each.
- The sequence of the swallow types will be randomized. The swallow will be performed under device pressure of zero, 20, 30, 40 and 60 mm Hg in a randomized fashion. Each swallow type will be repeated 5 times with 30-second intervals in between.
- The externally applied pressure will be measured by means of the pressure gauge included in the device
- All the subjects will be given the option to participate in the concurrent videofluoroscopic examination along with pharyngeal manometry
- The fluoroscopy machine will be turned "on" for 5 seconds only during the swallowing. The rest of the time fluoroscopy machine will be turned off.
- These subjects undergoing concurrent fluoroscopy and manometry will perform the following swallows at zero, 20, and 40 mm Hg of device pressure:
Dry swallows x 3 times.
5 ml and 10 ml of water mixed barium swallow at room temperature x 3 times each.
5 ml- mashed potatoes mixed with barium at room temperature x 3 times.
The participant will also be instructed to resume their regular diet and activity.
All the tracings and video recordings will be analyzed by two individuals in a blinded fashion.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Study of healthy subjects
| Arm | Type | Receives |
|---|---|---|
| Pharyngeal exerciser group | Experimental | Device: Pharyngeal exerciserTest that application of the pharyngeal exerciser increases the workload of muscles involved in pharyngeal phase of swallowing as evidenced manometrically by changes in Pharyngeal peak pressures Pharyngeal (velopharynx, oropharynx and hypopharynx) contractile duration Pharyngeal (velopharynx, oropharynx and hypopharynx) contractile integral Hypopharyngeal intrabolus pressure and duration UES nadir pressure UES relaxation time Baseline UES pressure |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Healthy volunteers must be at least 18 years of age or older.
Key exclusion criteria (15 listed)
- Subjects with cervical spine disorders.
- Subjects with neurological disorders like dementia, cerebrovascular diseases other than Parkinson's Disease
- Subjects with carotid artery bruit or carotid vascular disorders.
- Subjects suffering from muscle diseases like muscular dystrophies, myopathies.
- Subjects with neuro-muscular junction disorders myasthenia gravis, Eaton-Lambert disorders.
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 |
|---|---|---|
| Pharyngeal exerciserPharyngo-esophageal manometry during lateral fluoroscopy | Device | Pharyngeal exerciser group |
Primary outcome
laryngeal excursion during swallowing
Time frame: During mano-fluorography procedure
maximum laryngeal excursion from resting position measured from fluoroscopic images during swallowing
hyoid excursion during swallowing
Time frame: During mano-fluorography procedure
maximum hyoid bone excursion from resting position measured from fluoroscopic images during swallowing
upper esophageal sphincter (UES) opening during swallowing
Time frame: During mano-fluorography procedure
maximum UES anterior-posterior diameter measured from fluoroscopic images during swallowing
pharyngeal peak peristaltic pressure
Time frame: During mano-fluorography procedure
maximum deglutitive pressure within the pharynx
pharyngeal (velopharynx, oropharynx and hypopharynx) contractile duration
Time frame: During mano-fluorography procedure
manometric duration of peristaltic pressure wave in velopharynx, oropharynx and hypopharynx
pharyngeal (velopharynx, oropharynx and hypopharynx) contractile integral
Time frame: During mano-fluorography procedure
space-time and length integral of pharyngeal pressures in the velopharynx, oropharynx and hypopharynx
hypopharyngeal intrabolus pressure
Time frame: During mano-fluorography procedure
maximum pressure within the hypopharynx as the swallowed bolus covers the pressure sites within the hypopharynx
hypopharyngeal intrabolus duration
Time frame: During mano-fluorography procedure
duration of maximum pressure within the hypopharynx as the swallowed bolus covers the pressure sites within the hypopharynx
UES nadir pressure
Time frame: During mano-fluorography procedure
minimum pressure within the upper esophageal sphincter (UES) during UES deglutitive relaxation
UES relaxation time
Time frame: During mano-fluorography procedure
duration pressure drops within the upper esophageal sphincter during UES deglutitive relaxation
baseline UES pressure
Time frame: During mano-fluorography procedure
average UES pressure when no swallow activity is present
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2026.
- Individual participant dataSharing planned: No
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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.
Reza Shaker, MD principal investigator
Medical College of Wisconsin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pharyngeal exerciser in people with Dysphagia, run by Medical College of Wisconsin 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 1 inclusion and 15 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: looking for participants now, as of the sponsor's last update on 14 Jan 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Reza Shaker, MD (4149556840, rshaker@mcw.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
laryngeal excursion during swallowing (time frame: During mano-fluorography procedure). The study lists 11 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 14 Jan 2026.