Interventions for Patients With Alzheimer's Disease and Dysphagia

NCT03682081 | Completed FDA Device

• 5 other identifiers: 2018-0835A534255SMPH/MEDICINE/GER-AD DEVK76AG068590Protocol Version 5/21/2024
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

Brief Summary

The overall purpose of this project is to develop effective dysphagia rehabilitative interventions for patients with Alzheimer's Disease and related dementias at risk for pneumonia development.

Conditions

Dementia; Dysphagia; Alzheimer Disease

Keywords

Dementia; Dysphagia; Alzheimer's Disease; Treatment; Lingual Strengthening; Saliva substitute

Outcome Measures

Primary Outcomes (1)

• Change in Pharyngeal residue measured with the Normalized Residue Ratio Scale (NRRS)

  Pixel-based measure of post-swallow pharyngeal barium residue as observed on a videofluoroscopic swallow study captured at 30 frames per second. This measure will represent the amount of pharyngeal residue as it relates to the distance between cervical vertebrae 2 and 4 which serve as an anatomical scalar. A higher value represents more pharyngeal residue which is a worse outcome.

  Baseline, Post-treatment at approximately 8 weeks

Secondary Outcomes (10)

• Change in Modified Barium Swallow Impairment Profile (MBSImP) Overall Impairment Scores

  Baseline, Post-treatment at approximately 8 weeks

• Change in Penetration-Aspiration Scale Scores

  Baseline, Post-treatment at approximately 8 weeks

• Change in Lingual strength-maximal isometric lingual pressures

  Baseline, Post-treatment at approximately 8 weeks

• Change in Functional Oral Intake Scale

  Baseline, Post-treatment at approximately 8 weeks

• Change in Swallowing Quality of Life Questionnaire

  Baseline, Post-treatment at approximately 8 weeks.

Study Arms (4)

Usual care

NO 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.

Saliva Substitute Intervention

EXPERIMENTAL

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.

Device: Biotene Oral Balance Gel

Lingual Strengthening Intervention

EXPERIMENTAL

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.

Device: Isometric tongue strengthening facilitated by Iowa Oral Performance Instrument (IOPI)

Saliva Substitute and Lingual Strengthening Intervention

EXPERIMENTAL

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.

Device: Isometric tongue strengthening facilitated by Iowa Oral Performance Instrument (IOPI); Device: Biotene Oral Balance Gel

Interventions

Biotene Oral Balance Gel DEVICE

Participants will be instructed to apply an amount equivalent to about 1 cm of Biotene® Oral Balance Gel with a finger to the tongue and most intensely affected areas of the oral cavity three times a day after brushing their teeth for 8 weeks.

Also known as: Saliva substitute

Saliva Substitute Intervention; Saliva Substitute and Lingual Strengthening Intervention

Isometric tongue strengthening facilitated by Iowa Oral Performance Instrument (IOPI) DEVICE

An air-filled pressure bulb is placed on the surface of the oral tongue and pressed against the hard palate during exercise. Each patient is given a target pressure value to aim for as determined by the baseline one repetition maximum (1RM) lingual pressures. During week one of the regimen, the target value of each repetition will be 60% of the 1RM. For the remaining seven weeks, the target value will be increased to 80% of the 1RM. At weeks three, five, and seven, the baseline will be re-measured by phone and the 80% target value re-calculated.

Also known as: Tongue strengthening

Lingual Strengthening Intervention; Saliva Substitute and Lingual Strengthening Intervention

Eligibility Criteria

• Age: 50 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 50-99
• English speaking
• Diagnosis of dementia or cognitive impairment or memory loss
• Clinical Dementia Rating (CDR) scale score between 0.5 and 2.0
• Actively involved caregiver
• Resides at home, assisted living facility, or long-term care facility
• English speaking
• Age 18 and older
• Contact with patient at least 1 time a week
• Has access to a working telephone

You may not qualify if:

• Dementia due to cerebrovascular disease as primary cause
• History of head and neck cancer or other structural deformity that can affect swallowing
• Allergy to barium
• Currently breastfeed or pregnant or planning to become pregnant
• Lacks ability to give consent

Sponsors & Collaborators

• University of Wisconsin, Madison: lead
• National Institute on Aging (NIA): collaborator

Study Sites (1)

University of Wisconsin-Madison

Madison, Wisconsin, 53705, United States

Location

Related Publications (95)

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MeSH Terms

Conditions

Dementia; Deglutition Disorders; Alzheimer Disease

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases; Tauopathies; Neurodegenerative Diseases

Study Officials

• Nicole Rogus-Pulia, PhD, CCC-SLP

  University of Wisconsin, Madison

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 20, 2018
• First Posted: September 24, 2018
• Study Start: September 25, 2020
• Primary Completion: August 30, 2025
• Study Completion: November 30, 2025
• Last Updated: May 7, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)