Clinical trial NCT05708911: External Pharyngeal Exerciser and Pharyngeal Phase of Swallowing
Official title: Impact of External Pharyngeal Exerciser on Pharyngeal Phase of Swallowing
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Dysphagia
Lead sponsor: Medical College of Wisconsin
Sponsor class: OTHER
First posted: 2023-02-01
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Study of healthy subjects
Primary purpose: TREATMENT

Brief 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.

Detailed description: 1. All the study subjects are required to be without oral food or fluid intake for at least 3 hours prior to the study.
2. 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.
3. 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.
4. 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.
5. Patients will be sitting in an upright position and acclimatized for 10 minutes before proceeding.
6. Each subject will perform the following swallows:
7. 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.

8. 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.

9. The externally applied pressure will be measured by means of the pressure gauge included in the device

10. All the subjects will be given the option to participate in the concurrent videofluoroscopic examination along with pharyngeal manometry

11. 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.

12. 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.

Eligibility criteria: Inclusion Criteria:

* Healthy volunteers must be at least 18 years of age or older.

Exclusion Criteria:

* 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.
* 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.

Primary outcomes:
measure: laryngeal excursion during swallowing
timeFrame: During mano-fluorography procedure
measure: hyoid excursion during swallowing
timeFrame: During mano-fluorography procedure
measure: upper esophageal sphincter (UES) opening during swallowing
timeFrame: During mano-fluorography procedure
measure: pharyngeal peak peristaltic pressure
timeFrame: During mano-fluorography procedure
measure: pharyngeal (velopharynx, oropharynx and hypopharynx) contractile duration
timeFrame: During mano-fluorography procedure
measure: pharyngeal (velopharynx, oropharynx and hypopharynx) contractile integral
timeFrame: During mano-fluorography procedure
measure: hypopharyngeal intrabolus pressure
timeFrame: During mano-fluorography procedure
measure: hypopharyngeal intrabolus duration
timeFrame: During mano-fluorography procedure
measure: UES nadir pressure
timeFrame: During mano-fluorography procedure
measure: UES relaxation time
timeFrame: During mano-fluorography procedure
measure: baseline UES pressure
timeFrame: During mano-fluorography procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Milwaukee
country: United States
facility: Medical College of Wisconsin
state: Wisconsin
Study officials:
affiliation: Medical College of Wisconsin
name: Reza Shaker, MD
role: PRINCIPAL_INVESTIGATOR
References: