Assessing the effects of a pharyngeal exerciser on swallowing
Impact of External Pharyngeal Exerciser on Pharyngeal Phase of Swallowing
This study is testing how a throat exercise device can help both young and older people swallow better by measuring the pressure in their throats during swallowing.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years to 85 Years |
| Sex | All |
| Sponsor | Medical College of Wisconsin Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Milwaukee, Wisconsin) |
| Trial ID | NCT05708911 on ClinicalTrials.gov |
What this trial studies
This study evaluates how a pharyngeal exerciser affects the pressure in the throat during swallowing in healthy young and elderly individuals. Participants will undergo a series of swallowing tests with varying pressures applied by the device to measure the impact on pharyngeal muscle workload. The study involves precise measurements and recordings using high-resolution manometry to capture the swallowing dynamics. Each participant will perform multiple swallow types under different pressure conditions to assess the exerciser's effectiveness.
Who should consider this trial
Good fit: Ideal candidates are healthy adults aged 18 and older without any significant medical history affecting swallowing.
Not a fit: Patients with neurological disorders, cervical spine issues, or any current esophageal symptoms will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved therapies for individuals suffering from dysphagia by enhancing swallowing mechanics.
How similar studies have performed: While similar approaches have been explored, this specific application of a pharyngeal exerciser in healthy individuals is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Milwaukee, Wisconsin
- Medical College of Wisconsin — Milwaukee, Wisconsin, United States (Recruiting)
Study contacts
- Principal investigator: Reza Shaker, MD — Medical College of Wisconsin
- Study coordinator: Reza Shaker, MD
- Email: rshaker@mcw.edu
- Phone: 4149556840
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.