Clinical trial NCT05267314: External Pharyngeal Exerciser for Dysphagia
Official title: Impact of External Pharyngeal Exerciser on Dysphagia in Patients With Pharyngeal Weakness
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pharyngeal Dysphagia
Dysphagia
Oral Pharyngeal Dysphagia
Lead sponsor: University of Southern California
Sponsor class: OTHER
First posted: 2022-03-04
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Pharyngeal muscle weakness and dysphagia is common in individuals post-stroke or with Parkinson's disease and in individuals with head/neck cancer who have undergone surgery and/or radiation therapy. Therapeutic options for these patients are limited. This pilot study is intended to assess the feasibility, safety, and efficacy of the External Pharyngeal Exerciser (EPE) on patients with pharyngeal dysphagia receiving swallow therapy. Feasibility will be assessed by patient acceptance and practice records. Safety will be compared between groups to test whether there is an increased risk of the EPE versus standard therapy.

Detailed description: Pharyngeal dysphagia is incredibly common in individuals who suffer from neurological disorders such as stroke or Parkinson's disease and in individuals with head/neck cancer who have undergone surgery and/or radiation therapy. The pharyngeal muscles in these patients are weak. Other than standard patient-driven swallow therapy, the therapeutic options for these patients are limited. Response to standard patient-drive therapy is variable and dependent on a variety of factors including the muscles most affected by the underlying disorder and patient motivation. This pilot study is intended to assess the feasibility, safety, and efficacy of the External Pharyngeal Exerciser (EPE) on patients with pharyngeal dysphagia receiving swallow therapy. Feasibility will be assessed by patient acceptance and practice records. Safety will be compared between groups to test whether there is an increased risk of the EPE versus standard therapy.

Eligibility criteria: Inclusion Criteria:

* Pharyngeal dysphagia diagnosed with validated questionnaire and modified barium swallow. Participants must be at least 18 years of age or older.
* Pharyngeal dysphagia secondary to central neurological disorder such as Parkinson's disease or stroke
* Pharyngeal dysphagia head/neck cancer secondary to surgery/radiation
* Pharyngeal dysphagia secondary to elderly age \> 65

Exclusion Criteria:

* Carotid artery bruit or carotid vascular disorders
* Muscle diseases like muscular dystrophies, myopathies
* Neuro-muscular junction disorders myasthenia gravis, Eaton-Lambert disorders
* Current esophageal symptoms like heartburn, dysphagia, chest pain or regurgitation
* Autonomic dysfunction
* Pregnancy or lactation
* Advanced uncontrolled medical disorders (COPD, congestive heart failure, cirrhosis, cancer, chronic renal failure, etc)
* Medically unstable

Primary outcomes:
measure: Determine the number of adverse events associated with EPE
timeFrame: 1 year
measure: Determine efficacy as assessed by validated pharyngeal dysphagia questionnaire EAT-10
timeFrame: 1 year
measure: Determine efficacy: effect of EPE on swallowing via effects on pyriform sinus and vallecular residue height and width
timeFrame: 1 year
measure: Determine efficacy: effect of EPE on swallowing via effects on routinely measured markers of deglutition (penetration-aspiration scale, larynx and hyoid anterior/superior excursion; UES diameter, and pharyngeal transit time)
timeFrame: 1 year
Secondary outcomes:
measure: Physiologic change in swallow performance identified on routine Modified barium swallow
timeFrame: 1 year
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Anisa Shaker
state: California
Study officials:
References: