152 Participants Needed

Dysphagia Therapy for Alzheimer's Disease

VC
SG
MM
Overseen ByMeredith Mackowicz-Torres, MS, CCC-SLP
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: University of Wisconsin, Madison
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 2 JurisdictionsThis treatment is already approved in other countries

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?

Research shows that tongue strengthening exercises can improve tongue strength and swallowing, especially in older adults. This suggests that similar exercises, like those using the Iowa Oral Performance Instrument, may help Alzheimer's patients with swallowing difficulties.134610

Who Is on the Research Team?

NR

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

Clinical Dementia Rating (CDR) scale score between 0.5 and 2.0
Actively involved caregiver
Resides at home or an assisted living facility
See 3 more

Exclusion Criteria

My dementia is mainly caused by issues with my brain's blood vessels.
Patients with allergy to barium
My caregiver cannot legally agree to decisions for me.
See 2 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks
1 visit (in-person)

Baseline Assessment

Baseline assessment including sociodemographics, comorbidities, medications, cognitive assessment, and oral health status

1 week
1 visit (in-person)

Treatment

Participants undergo interventions including lingual strengthening and/or saliva substitute use for 8 weeks

8 weeks
Weekly follow-up calls

Follow-up

Participants are monitored for safety and effectiveness after treatment, including changes in salivary production, pneumonia diagnoses, and swallowing quality of life

24 weeks
Follow-up assessments at days 7, 14, 28, 42, 56, 90, and 180

What Are the Treatments Tested in This Trial?

Interventions

  • Biotene Oral Balance Gel
  • Isometric tongue strengthening facilitated by Iowa Oral Performance Instrument (IOPI)
Trial Overview The study tests tongue strengthening exercises using an Iowa Oral Performance Instrument (IOPI) and Biotene Oral Balance Gel to improve swallowing in Alzheimer's patients to prevent pneumonia.
How Is the Trial Designed?
4Treatment groups
Experimental Treatment
Active Control
Group I: Saliva Substitute and Lingual Strengthening InterventionExperimental Treatment2 Interventions
Group II: Saliva Substitute InterventionExperimental Treatment1 Intervention
Group III: Lingual Strengthening InterventionExperimental Treatment1 Intervention
Group IV: Usual careActive Control1 Intervention

Isometric tongue strengthening facilitated by Iowa Oral Performance Instrument (IOPI) is already approved in United States, European Union for the following indications:

🇺🇸
Approved in United States as IOPI for:
🇪🇺
Approved in European Union as IOPI for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Wisconsin, Madison

Lead Sponsor

Trials
1,249
Recruited
3,255,000+

National Institute on Aging (NIA)

Collaborator

Trials
1,841
Recruited
28,150,000+

Published Research Related to This Trial

In a study of 74 elderly adults over 8 weeks, tongue-hold swallowing exercises improved both anterior and posterior tongue strength, while tongue-pressure resistance training significantly increased only anterior tongue strength.
Both types of exercises led to increased salivary flow, with the tongue-pressure resistance training group showing a greater increase, but neither exercise significantly improved subjective oral health scores.
Effects of lingual exercises on oral muscle strength and salivary flow rate in elderly adults: a randomized clinical trial.Lee, KH., Jung, ES., Choi, YY.[2020]
A multi-center randomized controlled trial is being conducted to evaluate the effectiveness of a Stepwise Swallowing Training (SST) program for improving swallowing function in Alzheimer's disease patients, with a follow-up period of 4 weeks.
The SST program, which includes targeted exercises for various swallowing organs, aims to enhance swallowing abilities and reduce the negative impacts of dysphagia, potentially improving patients' eating behavior, daily activities, and nutritional status.
Evaluating the effectiveness of stepwise swallowing training on dysphagia in patients with Alzheimer's disease: study protocol for a randomized controlled trial.Wu, C., Zhang, K., Ye, J., et al.[2022]
Tongue strengthening exercises (TSE) significantly improve both anterior and posterior tongue strength compared to control groups, with a notable increase in strength measured in kilopascals (kPa) across 12 studies involving 388 participants.
The greatest improvements in anterior tongue strength were observed in older adults (≥ 65 years), suggesting that TSE could be particularly beneficial for this age group in enhancing swallowing function.
Effects of tongue strengthening exercises on tongue muscle strength: a systematic review and meta-analysis of randomized controlled trials.Lin, CJ., Lee, YS., Hsu, CF., et al.[2022]

Citations

Effects of lingual exercises on oral muscle strength and salivary flow rate in elderly adults: a randomized clinical trial. [2020]
Evaluating the effectiveness of stepwise swallowing training on dysphagia in patients with Alzheimer's disease: study protocol for a randomized controlled trial. [2022]
Effects of tongue strengthening exercises on tongue muscle strength: a systematic review and meta-analysis of randomized controlled trials. [2022]
Outcomes of tongue-pressure strength and accuracy training for dysphagia following acquired brain injury. [2022]
Standardized instrument for lingual pressure measurement. [2018]
A systematic review and meta-analysis of measurements of tongue and hand strength and endurance using the Iowa Oral Performance Instrument (IOPI). [2022]
Effects of two types of tongue strengthening exercises in young normals. [2022]
Relationship between skeletal muscle mass and swallowing function in patients with Alzheimer's disease. [2018]
Swallowing in moderate and severe phases of Alzheimer's disease. [2019]
Effects of a feeding intervention in patients with Alzheimer's disease and dysphagia. [2022]
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