Dysphagia Therapy for Alzheimer's Disease
What You Need to Know Before You Apply
What is the purpose of this trial?
This 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.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications.
Is tongue strengthening exercise safe for humans?
Research shows that tongue strengthening exercises, often using devices like the Iowa Oral Performance Instrument (IOPI), are generally safe for humans, including healthy adults and those with medical conditions. These exercises have been studied in various groups, and no significant safety concerns have been reported.12345
How is the isometric tongue strengthening treatment for dysphagia in Alzheimer's patients unique?
The isometric tongue strengthening treatment using the Iowa Oral Performance Instrument (IOPI) is unique because it focuses on improving tongue strength and accuracy through resistance training, which is not typically emphasized in other dysphagia treatments for Alzheimer's disease. This approach uses biofeedback to help patients achieve specific pressure targets, potentially enhancing swallowing function.36789
What data supports the effectiveness of this treatment for dysphagia in Alzheimer's patients?
Who Is on the Research Team?
Nicole Rogus-Pulia, PhD, CCC-SLP
Principal Investigator
University of Wisconsin, Madison
Are You a Good Fit for This Trial?
This trial is for English-speaking patients aged 50-99 with dementia or memory loss, scoring 0.5-2.0 on the CDR scale, living at home or in assisted living. Caregivers must be over 18, speak English, have weekly contact with the patient and a working phone. Excluded are those with certain cerebrovascular diseases, head/neck cancer history, barium allergies, or pregnancy.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Baseline Assessment
Baseline assessment including sociodemographics, comorbidities, medications, cognitive assessment, and oral health status
Treatment
Participants undergo interventions including lingual strengthening and/or saliva substitute use for 8 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment, including changes in salivary production, pneumonia diagnoses, and swallowing quality of life
What Are the Treatments Tested in This Trial?
Interventions
- Biotene Oral Balance Gel
- Isometric tongue strengthening facilitated by Iowa Oral Performance Instrument (IOPI)
Isometric tongue strengthening facilitated by Iowa Oral Performance Instrument (IOPI) is already approved in United States, European Union for the following indications:
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Wisconsin, Madison
Lead Sponsor
National Institute on Aging (NIA)
Collaborator