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25 Swallowing Disorders Trials
Power is an online platform that helps thousands of Swallowing Disorders patients discover FDA-reviewed trials every day. Every trial we feature meets safety and ethical standards, giving patients an easy way to discover promising new treatments in the research stage.
Swallowing impairments (dysphagia) frequently occur after stroke and have devastating consequences on overall health and quality of life, and long-term deficits in swallow function also increase risk of morbidity (e.g. depression) and mortality (i.e. aspiration pneumonia). As such, rehabilitation of swallow function to improve safety and efficiency of swallowing is essential in this population. This study aims to: 1) Provide preliminary data to evaluate the effect of a novel lingual endurance exercise on swallow function in individuals with post-stroke dysphagia; and 2) Collect preliminary data regarding changes in white matter tract diffusion and cortical thickness and from MRI data to better understand effects of lingual exercise training on neuroplasticity.
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:18+
Sex:All
Key Eligibility Criteria
Disqualifiers:Gastrointestinal Disease, TBI, Cancer, Others
70 Participants Needed
Lingual Strengthening Exercises for Swallowing Difficulty
Cincinnati, OhioThis multi-site trial will follow a cohort of Veterans with dysphagia for 8 weeks as they undergo clinically guided oropharyngeal exercises with oropharyngeal strengthening as the primary goal. Veterans with dysphagia will be assessed at three time points: baseline, 4 weeks after treatment initiation, and 8 weeks after treatment initiation. A non-dysphagic Veteran control group will also undergo data collection at parallel time points, without completion of a treatment paradigm. The investigators will then compare patients to non-dysphagic controls using manometry, videofluoroscopy, diet assessment, functional reserve tests, and patient-reported outcome measures.
The investigators aim to 1) quantify change in pressure measures of swallowing function resulting from dysphagia treatment; 2) determine which combination of standard of care and/or pressure-based metrics best track with outcome measures; and 3) develop multimodal prognostic algorithms that predict treatment success. This research will establish a precise outcome measurement paradigm suitable for dysphagia clinical care and research, thus improving clinical confidence and paving the way for a personalized medicine approach for dysphagia rehabilitation in Veterans.
No Placebo Group
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Unphased
Age:18 - 99
Sex:All
222 Participants Needed
Expiratory Muscle Strength Training for Hypernasal Speech
Pittsburgh, PennsylvaniaThis trial tests if breathing exercises with a small device can help people with speech problems caused by a cleft palate or similar issues. The exercises aim to make the muscles stronger so that the soft palate can close better, improving speech.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:5 - 17
Sex:All
Key Eligibility Criteria
Disqualifiers:Previous Speech Surgery, Others
30 Participants Needed
Wearable Biofeedback for Swallowing Disorders
West Lafayette, IndianaDysphagia, or difficulty swallowing, is a common symptom of many neurological diseases but its treatment is not well established or easily accessible.
To start addressing this gap, the researchers developed and validated a cost-effective wearable surface electromyography (sEMG) biofeedback sensor technology (i-Phagia), optimized to record muscle activity from the head/neck and provide biofeedback to patients and adherence data to clinicians during swallow therapy. This system has been developed with commercially available and widely used materials and the Purdue University IRB has determined that the device is non-significant risk device.
The goal of this clinical trial is to learn if this biofeedback (using this new technology/i-Phagia) when used as an adjunct to a standard swallow therapy protocol works to improve swallowing function in patients post chronic stroke or diagnosed with Parkinson's disease. It will also help the investigators learn whether this therapy protocol is equally effective when provided in-person versus via telehealth. Finally, it will determine which patient factors may influence how well the treatment works.
The main questions it aims to answer are:
* Does biofeedback (using this new technology/i-Phagia) when used as an adjunct to a standard swallow therapy protocol works better than a standard of care treatment to improve swallowing function in patients post chronic stroke or diagnosed with Parkinson's disease?
* Is completing the swallow therapy protocol at home (via telehealth) as effective as completing it in-person (in the clinic)?
* What factors related to the patients (e.g., age, diagnosis, etc.) may influence how well the treatment works?
Participants will:
* Complete a 12-week swallow treatment protocol (12 treatment visits) either in-person or at home (via telehealth)
* Complete 3 in-person evaluations (pre-treatment; post-treatment; and at a 12-week post treatment follow-up time point)
* Exercise at home several days per week and keep a diary/log of their home exercise
The hypothesis is that upon study completion, the efficacy of sEMG biofeedback-facilitated swallow therapy for both in-person and telehealth service delivery in two neurogenic dysphagia populations will have been established, and variables determining response to treatment will begin to be identified.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:50 - 90
Sex:All
120 Participants Needed
This trial tests a new method that teaches head and neck cancer survivors to swallow while exhaling. This approach aims to make swallowing safer and more efficient for those who have trouble swallowing after their cancer treatment.
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:18+
Sex:All
Key Eligibility Criteria
Disqualifiers:Neurological Disorders, Tracheostomy, NG Tube, Others
88 Participants Needed
HRM, FLIP, and Prucalopride for Dysphagia
Chicago, IllinoisSwallowing difficulties are extremely common and result in substantial morbidity, reduction in the quality of life, and mortality related to malnutrition and complications from regurgitation and aspiration. Unfortunately, our understanding regarding the pathophysiology of dysphagia and GERD has been hampered by focusing predominantly on circular muscle activity and ignoring the essential biomechanical properties of the esophageal wall that promote normal emptying. Our initial work explored the relationship between intrabolus pressure (IBP) and esophagogastric junction (EGJ) compliance as a metric for outflow resistance. This work highlighted the direct relationship between IBP and EGJ opening and was the foundation for the development of the classification scheme utilized around the world to diagnose esophageal motor disorders: "the Chicago Classification" (CC). Despite this improved understanding focused on bolus transit dynamics, there are still significant gaps in our scientific understanding centered on the lack of a true correlate for symptoms, reliable predictive models and effective treatments for Functional dysphagia, IEM and EGJOO. Given these limitations, we have developed novel approaches that combine assessments of primary and secondary peristalsis (a NeuroMyogenic Model of esophageal function). These will leverage our recent findings supporting the importance of the esophageal response to distension in bolus clearance, noting that this response of the esophageal wall to bolus retention or reflux is one of the most essential functions of the esophagus in preventing complications of aspiration, or reflux injury. We will also include an assessment of esophageal geometry and wall biomechanics (elasticity/dilatation) as these carry essential interactions with esophageal function that are overlooked in the current diagnostic paradigms.
In order to test our hypothesis that wall mechanics are a major determinant of esophageal diseases, we had to develop new approaches and new technology to directly measure mechanical wall state, descending inhibition and LES opening. Using impedance techniques combined with manometry, we are now capable of assessing IBP and diameter changes across a space-time continuum (4D HRM). We also developed physics-based hybrid diagnostics that include a FLIP technique to assess esophageal work and power during volumetric distention (FLIP-MECH) and a fluoroscopy approach that simultaneously assesses esophageal diameter-pressure relationships (Fluoro-MECH). We also developed a new approach, Interactive FLIP Panometry, which facilitates an assessment of descending inhibition and the mechanism behind impaired LES opening. These tools will allow us to expand our models to combine an assessment of neuromyogenic function simultaneously with geometry. Our overarching goal will be to study well-defined patient populations (Functional Dysphagia, IEM/GERD, EGJOO and Achalasia) before and after targeted interventions to test the NeuroMyogenic and MechanoGeometric Model. This work will build upon the previous success of the CC and help advance the evolution of the CC by defining new, relevant biomechanical physiomarkers of disease activity that can identify new targets for therapeutic intervention and facilitate prediction of clinical outcomes.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:18 - 85
Sex:All
575 Participants Needed
Early Speech and Swallowing Therapy for Head and Neck Cancer
Toronto, OntarioOral cavity cancer (OCC) is one of the most common cancers worldwide, with tongue cancer being one of the most common subtypes. Patients with oral cancers can experience painful swallowing, swallowing difficulty (dysphagia), and associated weight loss long after surgery. Not only is dysphagia an independent predictor of quality of life (QoL) in cancer survivorship, it can also have a devastating impact on the health of patients resulting from complications such as pneumonia, malnutrition and feeding tube dependence. Emerging evidence suggests that patients undergoing surgery benefit from engaging with speech-language pathologists (SLPs) before problems arise, to learn swallow strategies that may become useful in their rehabilitation. This in turn has the potential to reduce complications and minimize the length of feeding tube dependency.
This study will assess the feasibility of conducting a prospective clinical trial that would evaluate the effects on patient health, function and overall benefit of early and systematic SLP speech and swallowing intervention for head and neck cancer patients planned for curative surgical treatment. We will also assess long-term changes in select clinical and patient-reported outcomes comparing their status before, and one month after, treatment.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:18+
Sex:All
40 Participants Needed
EMST for Swallowing Disorders in Head and Neck Cancer Patients
Milwaukee, WisconsinThis trial is testing whether a breathing exercise called Expiratory Muscle Strength Training (EMST) can help patients with head and neck cancer who are undergoing radiation therapy or chemoradiotherapy improve their swallowing. The exercise aims to make the muscles used for breathing out stronger, which may also help with swallowing. EMST is an intervention for patients with oropharyngeal dysphagia and has been proven effective in previous studies.
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:18+
Sex:All
Key Eligibility Criteria
Disqualifiers:Primary Surgery, Unknown Tumor, Neurologic Conditions, Others
30 Participants Needed
Respiratory Strength Training for Heart Transplant Recipients
Nashville, TennesseeThis research study is investigating whether completing breathing exercises before surgery helps heart transplant patients recover after surgery. Previous studies have shown that breathing exercises can improve breathing, cough, and swallow function in patients with other diseases/conditions. The current study will investigate the impact of a preoperative respiratory muscle strength training program on breathing and cough function, swallow function, patient-reported eating and swallowing fatigue, and health outcomes in individuals undergoing heart transplantation.
Participants will:
* undergo tests of breathing, cough, and swallow function
* complete questionnaires about the treatment, their swallow function
* complete breathing exercises daily
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:18 - 90
Sex:All
Key Eligibility Criteria
Disqualifiers:Under 18, Over 90, Pregnant, Others
90 Participants Needed
Non-invasive Esophageal Testing for Swallowing Disorders
Nashville, TennesseeThe investigator proposes to study electrical activity reflective of esophageal motility in adults noninvasively by the use of multichannel electroesophagogram (EESG) and magnetoesophagogram (MESG) recordings.
No Placebo Group
Trial Details
Trial Status:Enrolling By Invitation
Trial Phase:Unphased
Age:18+
Sex:All
90 Participants Needed
Air Bolus Effects for Swallowing Disorders
Milwaukee, WisconsinUnderstanding the correlation between the transmission of a bolus from the pharynx into the proximal esophagus and activating primary esophageal peristalsis.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:21 - 90
Sex:All
Key Eligibility Criteria
Disqualifiers:Pharyngo-esophageal Disease, Pregnancy, Others
40 Participants Needed
Pharyngeal Exerciser for Swallowing Disorders
Milwaukee, WisconsinThis 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.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:18 - 85
Sex:All
Key Eligibility Criteria
Disqualifiers:Neurological Disorders, Muscle Diseases, Esophageal Symptoms, Others
60 Participants Needed
Throat Exerciser for Swallowing Disorders
Milwaukee, WisconsinThe goal of this a clinical trial is to test the effect of a pharyngeal exerciser in rehabilitation of pharyngeal phase of swallowing in patients with dysphagia. The main question it aims to answer is:
•Does application of pharyngeal exerciser improve swallowing as evidenced by need for prescribed intervention for dysphagia (maneuvers, exercises or dietary modification to prevent aspiration).
Participants will:
* Perform barium swallows in lateral view fluoroscopy
* Over a six-week period, perform thrice daily sessions of swallowing with an external, laryngeal restriction device covering the larynx
* Return for another fluoroscopic barium swallow study
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:18+
Sex:All
Key Eligibility Criteria
Disqualifiers:Head/neck Cancer, Muscle Diseases, Pregnancy, Others
160 Participants Needed
Swallow Muscle Exercises for Swallowing Disorders
Milwaukee, WisconsinThe investigators hypothesize that striated esophagus deglutitive motor function is modulated by pharyngeal phase swallowing biomechanics.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:18 - 90
Sex:All
Key Eligibility Criteria
Disqualifiers:Muscle Diseases, Neuro-muscular Disorders, Others
557 Participants Needed
Dysphagia Therapy for Alzheimer's Disease
Madison, WisconsinThis trial tests a saliva gel and tongue exercises to help people with Alzheimer's who have trouble swallowing. These patients are at risk of pneumonia because they can't swallow well. The saliva gel keeps their mouth moist, and the exercises make their tongue stronger to help with swallowing.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:50 - 99
Sex:All
Key Eligibility Criteria
Disqualifiers:Cerebrovascular Disease, Head/neck Cancer, Others
152 Participants Needed
Behavioral Intervention for Swallowing Difficulty
New York, New YorkThis study will prospectively recruit and enroll patients undergoing primary Anterior Cervical Discectomy and Fusion (ACDF) surgeries at NYU Langone. Participants will undergo pre-operative and six-week post-operative swallowing assessment using videofluoroscopy (VFSS). Acoustic voice samples and Patient Reported Outcome Measures (PROMs) for swallowing and voice will also be collected. Beginning one-week before surgery participants will begin a behavioral health program that will be continued for six-weeks after surgery. The primary goal of this study will be to determine whether a preventative behavioral health program improves instrumental measures of swallowing and voice six-weeks after ACDF surgery. .
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:21 - 99
Sex:All
50 Participants Needed
Photodynamic Therapy for Esophageal Cancer
New York, New YorkThe purpose of this study is to establish the highest dose of laser light for WST-11 VTP to treat obstruction from esophageal cancer that can be safely given.
No Placebo Group
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 1
Age:18+
Sex:All
12 Participants Needed
Thickened Feeds for Swallowing Disorders
Boston, MassachusettsThis trial will test if thickening baby formula can help infants who have trouble swallowing. The study focuses on infants with swallowing issues and unexplained choking episodes. Thicker liquids are easier to swallow and may reduce choking risks. Thicker liquids are often recommended to reduce the risk of swallowing problems.
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:0 - 21
Sex:All
Key Eligibility Criteria
Disqualifiers:Seizure Disorders, Congenital Heart Disease, Others
200 Participants Needed
Diaphragmatic Breathing for Esophageal Disorders
Jacksonville, FloridaThe goal of this study is to determine which position, maneuvers or combination thereof generates the highest pressure at the EGJ as assessed by high-resolution esophageal manometry and thus greater or more robust contraction of the diaphragm.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:18+
Sex:All
30 Participants Needed
Screening Methods for Swallowing Disorders
Miami, FloridaThis trial is studying ways to check for swallowing problems in stroke patients. It focuses on people who have had a stroke because they often have trouble swallowing. The tests help doctors find out if these patients are at risk of health issues from swallowing difficulties.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:18+
Sex:All
Key Eligibility Criteria
Disqualifiers:Age > 80, Pregnancy, Prisoners, Others
50 Participants Needed
This trial studies how well manual therapy works in treating fibrosis-related late effect dysphagia in head and neck cancer survivors. Manual therapy is the use of massage and stretching exercises to increase blood flow and muscle movement in the neck, throat, jaw, and mouth, which may help to improve swallowing ability and range of motion in participants who have had treatment for head and neck cancer.
No Placebo Group
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Unphased
Age:18+
Sex:All
24 Participants Needed
Corticosteroids for Swallowing Difficulty
Aurora, ColoradoThis is a placebo-controlled, double-blind randomized trial of a short course of intravenous corticosteroids for Acute Respiratory Failure Survivors with Fiberoptic Endoscopic Evaluation of Swallowing (FEES) documented laryngeal edema. Study was leveraged using the existing R01 grant infrastructure COMIRB # 21-3873, study design, and research methods. Patients for the study proposed will have already been enrolled in the R01 longitudinal cohort study. The sites to perform this study include Colorado, BU, Yale, and Stanford. Those R01-enrolled patients with laryngeal edema on their initial FEES examination: defined as the revised Patterson edema score greater than zero, will be approached for enrollment.
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 2
Age:18+
Sex:All
Key Eligibility Criteria
Disqualifiers:Dysphagia, Neuromuscular Disorder, Tracheostomy, Others
Must Not Be Taking:Immunosuppressives, Corticosteroids
80 Participants Needed
Salt Water Gargling for Swallowing Difficulty
Los Angeles, CaliforniaThe goal of this randomized control trial is to collect sufficient preliminary data on the efficacy of sodium chloride, hereafter referred to as "saltwater" or "saline" in reducing the difficulty of swallowing following multi-level anterior cervical discectomy and fusion (ACDF) procedures. The study population will consist of generally healthy adults ages 18 - 80. The main question it aims to answer is:
If the symptomatology and severity of swallowing difficulties following ACDF surgery can be reduced by gargling with warm salt water.
Researchers will compare the control and interventional arms to see if the proposed intervention of gargling with warm salt water improves difficulty swallowing following surgery.
Patients in the control arm will be asked to:
- Complete three (3) questionnaires at specified intervals (preoperative, postoperative day (POD) 1, 2, and 7; and at 1-month postoperatively).
Patients in the experimental/interventional arm will be asked to:
* Complete three (3) questionnaires at specified intervals (preoperative, postoperative day (POD) 1, 2, and 7; and at 1-month postoperatively).
* Gargle with a warm saltwater solution once on POD 0, and thrice daily from POD 1 to POD 7.
No Placebo Group
Trial Details
Trial Status:Not Yet Recruiting
Trial Phase:Unphased
Age:18 - 80
Sex:All
50 Participants Needed
TEE Techniques for Swallowing Difficulty After Lung Transplant
Los Angeles, CaliforniaThe primary outcome of this study is dysphagia (difficulty swallowing) on postoperative speech and swallow evaluation following lung transplantation.
Transesophageal echocardiography (TEE) (creates pictures of the heart from inside the participants body) is routinely performed for all lung transplantations at the University of California, Los Angeles (UCLA) and it is the standard of care. Patients are randomized to two groups. The intervention group would limit the number of TEE clips (# pictures taken) per case. The control group would leave the number of TEE clips to the discretion of the attending anesthesiologist.
The investigators hypothesize that reduction in TEE imaging during lung transplantation will reduce dysphagia.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:18+
Sex:All
Key Eligibility Criteria
Disqualifiers:Perforated Esophagus, Esophageal Stricture, Others
116 Participants Needed
Negative Pressure Suction for Oropharyngeal Dysphagia
Sacramento, CaliforniaThis is an investigator initiated prospective study to determine whether the use of a negative pressure suction in the hypopharynx will reduce the amount of aspiration during Video Fluoroscopic Swallowing Exam (VFSE) among patients with oropharyngeal dysphagia.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:18+
Sex:All
10 Participants Needed
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Frequently Asked Questions
How much do Swallowing Disorders clinical trials pay?
Each trial will compensate patients a different amount, but $50-100 for each visit is a fairly common range for Phase 2–4 trials (Phase 1 trials often pay substantially more). Further, most trials will cover the costs of a travel to-and-from the clinic.
How do Swallowing Disorders clinical trials work?
After a researcher reviews your profile, they may choose to invite you in to a screening appointment, where they'll determine if you meet 100% of the eligibility requirements. If you do, you'll be sorted into one of the treatment groups, and receive your study drug. For some trials, there is a chance you'll receive a placebo. Across Swallowing Disorders trials 30% of clinical trials have a placebo. Typically, you'll be required to check-in with the clinic every month or so. The average trial length for Swallowing Disorders is 12 months.
How do I participate in a study as a "healthy volunteer"?
Not all studies recruit healthy volunteers: usually, Phase 1 studies do. Participating as a healthy volunteer means you will go to a research facility several times over a few days or weeks to receive a dose of either the test treatment or a "placebo," which is a harmless substance that helps researchers compare results. You will have routine tests during these visits, and you'll be compensated for your time and travel, with the number of appointments and details varying by study.
What does the "phase" of a clinical trial mean?
The phase of a trial reveals what stage the drug is in to get approval for a specific condition. Phase 1 trials are the trials to collect safety data in humans. Phase 2 trials are those where the drug has some data showing safety in humans, but where further human data is needed on drug effectiveness. Phase 3 trials are in the final step before approval. The drug already has data showing both safety and effectiveness. As a general rule, Phase 3 trials are more promising than Phase 2, and Phase 2 trials are more promising than phase 1.
Do I need to be insured to participate in a Swallowing Disorders medical study ?
Clinical trials are almost always free to participants, and so do not require insurance. The only exception here are trials focused on cancer, because only a small part of the typical treatment plan is actually experimental. For these cancer trials, participants typically need insurance to cover all the non-experimental components.
What are the newest Swallowing Disorders clinical trials ?
Most recently, we added Wearable Biofeedback for Swallowing Disorders, Expiratory Muscle Strength Training for Hypernasal Speech and Salt Water Gargling for Swallowing Difficulty to the Power online platform.