Dysphagia Therapy for Alzheimer's Disease

Overseen By Meredith Mackowicz-Torres, MS, CCC-SLP

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Wisconsin, Madison

Disqualifiers: Cerebrovascular disease, Head/neck cancer, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 9

Duration: 8 weeks

152 Participants Needed

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. ^{1 2 3 4 5}

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. ^{3 6 7 8 9}

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. ^{1 3 4 6 10}

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

Clinical Dementia Rating (CDR) scale score between 0.5 and 2.0

Actively involved caregiver

Resides at home or an assisted living facility

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.

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?

Group I: Saliva Substitute and Lingual Strengthening Intervention Experimental Treatment 2 Interventions

Each patient-caregiver dyad will be provided with a commercially available gel-based saliva substitute, Biotene® Oral Balance Gel that will be applied regularly to the oral cavity for 8 weeks. Each dyad will also be trained in the lingual strengthening protocol and will undergo this intervention for 8 weeks. Isometric tongue strengthening will be facilitated by the Iowa Oral Performance Instrument (IOPI) device.

Group II: Saliva Substitute Intervention Experimental Treatment 1 Intervention

Each patient-caregiver dyad will be provided with a commercially available gel-based saliva substitute, Biotene® Oral Balance Gel that will be applied to the oral cavity regularly for 8 weeks.

Group III: Lingual Strengthening Intervention Experimental Treatment 1 Intervention

Patient-caregiver dyads will be trained in the lingual strengthening protocol and patients will undergo this intervention for 8 weeks. Isometric tongue strengthening will be facilitated by the Iowa Oral Performance Instrument (IOPI) device.

Group IV: Usual care Active Control 1 Intervention

Usual care groups will receive standard swallowing interventions identified by the Speech-Language Pathologist as appropriate to treat the patient's dysphagia and common in clinical practice. Such treatment would likely consist of dietary (e.g., thickened liquids or pureed foods) or postural compensatory strategies (e.g., chin down posture while swallowing). No progressive lingual strengthening approaches or regimented salivary substitute protocols are utilized.

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:

• Dysphagia rehabilitation
• Swallowing disorders

Approved in European Union as IOPI for:

• Dysphagia rehabilitation
• Swallowing disorders

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

In a study of six adults with chronic dysphagia due to brain injury, 24 sessions of tongue-pressure resistance training over 11-12 weeks led to significant improvements in tongue strength and swallowing safety, as indicated by better post-treatment tongue pressure and reduced penetration-aspiration scores.

However, some patients experienced worsening pharyngeal residue, suggesting that while the training improved certain aspects of swallowing, it may not address all issues related to dysphagia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Outcomes of tongue-pressure strength and accuracy training for dysphagia following acquired brain injury. Steele, CM., Bailey, GL., Polacco, RE., et al.[2022]

The Madison Oral Strengthening Therapeutic (MOST) device was developed to improve tongue muscle strength and address swallowing difficulties, showing promise in both treatment and prevention of muscle atrophy.

The study compared the MOST device to the Iowa Oral Performance Instrument (IOPI) and aimed to determine the best sampling rate for measuring tongue pressure during exercises, highlighting its potential for broader use in healthy aging adults.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Standardized instrument for lingual pressure measurement. Hewitt, A., Hind, J., Kays, S., et al.[2018]

The Iowa Oral Performance Instrument (IOPI) is a reliable tool for measuring tongue strength and endurance, supported by evidence from 38 studies, primarily involving healthy adults and individuals with conditions like Parkinson's disease and head or neck cancer.

There is emerging evidence for the IOPI's effectiveness in assessing hand strength and endurance, indicating its potential utility beyond just tongue measurements in both healthy and clinical populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A systematic review and meta-analysis of measurements of tongue and hand strength and endurance using the Iowa Oral Performance Instrument (IOPI). Adams, V., Mathisen, B., Baines, S., et al.[2022]

In a pilot study involving 31 healthy young subjects, tongue strengthening exercises significantly improved maximum tongue strength compared to a control group that did not exercise, indicating the efficacy of these exercises (p = 0.04).

Both types of tongue exercises, whether using a tongue depressor or the Iowa Oral Performance Instrument, were effective in enhancing tongue function, supporting the idea that targeted exercises can strengthen tongue muscles.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of two types of tongue strengthening exercises in young normals. Lazarus, C., Logemann, JA., Huang, CF., et al.[2022]

In a study of 232 Alzheimer's patients averaging 85.4 years old, decreased skeletal muscle mass was significantly associated with the severity of Alzheimer's disease and poor swallowing function.

Factors such as a clinical dementia rating of 3, low body mass index, and small calf circumference were identified as strong predictors of decreased skeletal muscle, highlighting the need for interventions to address swallowing difficulties in these patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Relationship between skeletal muscle mass and swallowing function in patients with Alzheimer's disease. Takagi, D., Hirano, H., Watanabe, Y., et al.[2018]

The study involved 50 patients with moderate to severe Alzheimer's disease (AD) and identified specific feeding and swallowing difficulties, such as passivity and distraction, which were more pronounced in patients with greater cognitive impairment (CDR2 and CDR3 groups).

These feeding and swallowing issues were correlated with the severity of communication and swallowing difficulties in AD patients, highlighting the need for targeted support for caregivers and healthcare professionals to manage these challenges effectively.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Swallowing in moderate and severe phases of Alzheimer's disease. Correia, Sde M., Morillo, LS., Jacob Filho, W., et al.[2019]

A three-month feeding intervention for 30 nursing home residents with Alzheimer's disease significantly improved food intake and nutritional status, as evidenced by increased skinfold thickness, arm circumference, serum albumin, and hemoglobin levels (all p < 0.01).

The intervention also enhanced eating compliance, with five out of 22 patients who initially required feeding regaining the ability to self-feed, indicating potential for improved quality of life in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of a feeding intervention in patients with Alzheimer's disease and dysphagia. Chen, LL., Li, H., Lin, R., et al.[2022]

Citations

1. Japan pubmed.ncbi.nlm.nih.gov

Effects of lingual exercises on oral muscle strength and salivary flow rate in elderly adults: a randomized clinical trial. [2020]

2. England pubmed.ncbi.nlm.nih.gov

Evaluating the effectiveness of stepwise swallowing training on dysphagia in patients with Alzheimer's disease: study protocol for a randomized controlled trial. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Effects of tongue strengthening exercises on tongue muscle strength: a systematic review and meta-analysis of randomized controlled trials. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Outcomes of tongue-pressure strength and accuracy training for dysphagia following acquired brain injury. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Standardized instrument for lingual pressure measurement. [2018]

6. United States pubmed.ncbi.nlm.nih.gov

A systematic review and meta-analysis of measurements of tongue and hand strength and endurance using the Iowa Oral Performance Instrument (IOPI). [2022]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Effects of two types of tongue strengthening exercises in young normals. [2022]

8. Japan pubmed.ncbi.nlm.nih.gov

Relationship between skeletal muscle mass and swallowing function in patients with Alzheimer's disease. [2018]

9. Germany pubmed.ncbi.nlm.nih.gov

Swallowing in moderate and severe phases of Alzheimer's disease. [2019]

10. England pubmed.ncbi.nlm.nih.gov

Effects of a feeding intervention in patients with Alzheimer's disease and dysphagia. [2022]