CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 76 enrolled
Drug / intervention
Isometric tongue strengthening facilitated by Iowa Oral Performance Instrument (IOPI) +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03682081
NCT03682081N/ACompleted

Impact of Novel Rehabilitative Approaches for Dysphagia in Patients With Alzheimer's Disease and Related Dementias

University of Wisconsin, Madison·interventional·Posted Sep 24, 2018·Updated May 7, 2026

In Brief

A clinical study evaluating Isometric tongue strengthening facilitated by Iowa Oral Performance Instrument (IOPI) and Biotene Oral Balance Gel for Dementia and 2 related conditions. Completed, enrolled 76 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

N/ACompletedFinished
20192020202120222023202420252026
First PostedSep 24, 2018
Enrollment StartSep 25, 2020
Primary CompletionAug 30, 2025
Study CompletionNov 30, 2025
TodayJul 2, 2026
Enrollment to primary: 4.9 yearsPosted 7.8 years ago

Interventions

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.

Biotene Oral Balance Geldevice

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.