Pharyngeal DysphagiaNCT05267314
External Pharyngeal Exerciser for Dysphagia
A study testing pharyngeal exerciser + standard therapy in people with Pharyngeal Dysphagia and Dysphagia, run by University of Southern California at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pharyngeal Dysphagia, Dysphagia, Oral Pharyngeal Dysphagia
- What is being tested?
- pharyngeal exerciser + standard therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Dec 2021to 6 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Anisa Shaker
Los Angeles, California, 90089-1016
Anisa Shaker, 323-442-2084, ashaker@usc.edu
About this study
Official title: Impact of External Pharyngeal Exerciser on Dysphagia in Patients With Pharyngeal Weakness
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.
Read the 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.
- Conditions
- Pharyngeal Dysphagia, Dysphagia, Oral Pharyngeal Dysphagia
- Being tested
- pharyngeal exerciser + standard therapy
- 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 exerciser + standard therapyDevice
Use of Pharyngeal exerciser
| Study group | Role | What they receive |
|---|---|---|
| standard therapy | No intervention | standard therapy |
| exerciser and standard therapy | Experimental | exerciser and standard therapy Receives: Device: pharyngeal exerciser + standard therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine the number of adverse events associated with EPE
The aim is to determine whether there are any risks associated with the use of the EPE. There are no known risks to placing external pressure to the larynx. However, there is the possibility that the participant may experience discomfort such as rash or may not be able to tolerate the minimal pressure associated with the exerciser. The participant will be evaluated every two weeks by the study physician and reports of adverse events will be recorded. If the participant experiences difficulty in tolerating the minimal pressure, the study will be stopped.
Measured: 1 year
Determine efficacy as assessed by validated pharyngeal dysphagia questionnaire EAT-10
Subjective evaluation of participant response to an External Pharyngeal Exerciser with a validated pharyngeal dysphagia questionnaire (EAT-10) administered as standard of care before and after therapy (scores 1-10, with higher scores mean worse outcome).
Measured: 1 year
Determine efficacy: effect of EPE on swallowing via effects on pyriform sinus and vallecular residue height and width
To objectively define pharyngeal response to External Pharyngeal Exerciser with Modified Barium swallow before and after therapy: To determine if application of pharyngeal exerciser changes swallowing as evidenced by reduction in height and width of pyriform sinus and vallecular residue using fluoroscopy study.
Measured: 1 year
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)
To objectively define pharyngeal response to External Pharyngeal Exerciser with Modified Barium swallow before and after therapy: To determine if application of pharyngeal exerciser changes deglutition as noticed by 1) change in aspiration and penetration measured by Rosenbek's penetration-aspiration scale; 2) change in anterior and superior excursion of larynx and hyoid; 3) change in AP and Lateral diameter of UES; 4) change in pharyngeal transit time.
Measured: 1 year
Secondary outcomes (1)
Physiologic change in swallow performance identified on routine Modified barium swallow
Physiologic changes in swallow performance: oral-motor strength, vocal cord adduction with various food consistencies, presence of penetration/aspiration, length of anterior and superior excursion of larynx, pharyngeal transit time, presence and width of vallecular/piriform residue. Poor anterior or superior excursion of larynx, diminished AP and lateral diameter of UES, presence of residue, penetration/aspiration suggests pharyngeal dysphagia. These measurements will be combined/aggregated to arrive at one reported value.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2022
- Study start7 Dec 2021
- Primary completion6 Dec 2022 (estimated)
- Study completion6 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pharyngeal DysphagiaStudies of the same condition, open and under way.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Southern California
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anisa Shaker, University of Southern California
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05267314
- Sponsor's protocol ID
- HS-16-00374
- Status last verified
- Feb 2022
- First submitted
- 24 Jan 2022
- Last updated
- 4 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of External Pharyngeal Exerciser on Dysphagia in Patients With Pharyngeal Weakness
- ClinicalTrials.gov ID
- NCT05267314
- Acronym / sponsor ID
- HS-16-00374
- Conditions
- Pharyngeal Dysphagia, Dysphagia, Oral Pharyngeal Dysphagia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of Southern CaliforniaUniversity, hospital or other
- Study start
- 7 Dec 2021 (actual)
- Primary completion
- 6 Dec 2022 (estimated)
- Study completion
- 6 Dec 2022 (estimated)
- First posted
- 4 Mar 2022 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| standard therapy | No intervention | –standard therapy |
| exerciser and standard therapy | Experimental | Device: pharyngeal exerciser + standard therapyexerciser and standard therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- 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
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 exerciser + standard therapyUse of Pharyngeal exerciser | Device | exerciser and standard therapy |
Primary outcome
Determine the number of adverse events associated with EPE
Time frame: 1 year
The aim is to determine whether there are any risks associated with the use of the EPE. There are no known risks to placing external pressure to the larynx. However, there is the possibility that the participant may experience discomfort such as rash or may not be able to tolerate the minimal pressure associated with the exerciser. The participant will be evaluated every two weeks by the study physician and reports of adverse events will be recorded. If the participant experiences difficulty in tolerating the minimal pressure, the study will be stopped.
Determine efficacy as assessed by validated pharyngeal dysphagia questionnaire EAT-10
Time frame: 1 year
Subjective evaluation of participant response to an External Pharyngeal Exerciser with a validated pharyngeal dysphagia questionnaire (EAT-10) administered as standard of care before and after therapy (scores 1-10, with higher scores mean worse outcome).
Determine efficacy: effect of EPE on swallowing via effects on pyriform sinus and vallecular residue height and width
Time frame: 1 year
To objectively define pharyngeal response to External Pharyngeal Exerciser with Modified Barium swallow before and after therapy: To determine if application of pharyngeal exerciser changes swallowing as evidenced by reduction in height and width of pyriform sinus and vallecular residue using fluoroscopy study.
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)
Time frame: 1 year
To objectively define pharyngeal response to External Pharyngeal Exerciser with Modified Barium swallow before and after therapy: To determine if application of pharyngeal exerciser changes deglutition as noticed by 1) change in aspiration and penetration measured by Rosenbek's penetration-aspiration scale; 2) change in anterior and superior excursion of larynx and hyoid; 3) change in AP and Lateral diameter of UES; 4) change in pharyngeal transit time.
1 secondary outcome
Physiologic change in swallow performance identified on routine Modified barium swallow
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2022.
- Individual participant dataSharing planned: No
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Dysphagia
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. This study is not recruiting at the moment.
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 + standard therapy in people with Pharyngeal Dysphagia and Dysphagia, run by University of Southern California 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 4 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 4 Mar 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Associate Professor of Medicine (3234422084, ashaker@usc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determine the number of adverse events associated with EPE (time frame: 1 year). The study lists 4 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 4 Mar 2022.