Using a pharyngeal exerciser to improve swallowing in patients with dysphagia
Effect of Pharyngeal Exerciser in Rehabilitation of Pharyngeal Phase of Swallowing in Patients With Dysphagia
This study is testing if a special device that helps exercise the throat can improve swallowing for people with dysphagia.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 160 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Medical College of Wisconsin Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Milwaukee, Wisconsin) |
| Trial ID | NCT05708898 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effectiveness of a pharyngeal exerciser in rehabilitating the swallowing function of patients with dysphagia. Participants will undergo a series of barium swallow tests and perform thrice-daily swallowing exercises with the device over a six-week period. The study will assess improvements in swallowing ability, as indicated by the need for additional interventions to prevent aspiration. A thorough medical evaluation will ensure appropriate candidate selection and monitoring throughout the trial.
Who should consider this trial
Good fit: Ideal candidates are healthy elderly adults aged 65 and older with dysphagia characterized by persistent pharyngeal residue.
Not a fit: Patients under 18, those with recent head and neck cancer, or individuals with certain neuromuscular disorders may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly enhance swallowing function and quality of life for patients with dysphagia.
How similar studies have performed: While similar approaches have been explored, this specific application of a pharyngeal exerciser is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients with dysphagia characterized by persistent pharyngeal residue on fluoroscopic study undergoing rehabilitative intervention (e.g.: exercises, maneuvers or dietary modification) for improving swallowing and preventing aspiration Healthy elderly adult (≥65 years of age). Exclusion Criteria: * Patients younger than 18 years of age. Patients with recent head and neck cancer (\<1 month post-surgery or \<3 months post-chemo radiation. Patients suffering from muscle diseases like muscular dystrophies, myopathies. Patients with neuro-muscular junction disorders myasthenia gravis, Eaton-Lambert disorders Patients having history of allergy to lidocaine or barium. Patients who are pregnant or lactating. Patients who are medically unstable. Patients who are unable to apply the exerciser independently or with the help of a caregiver. Patients who lack cognition.
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.