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Simple tongue workouts could cut pneumonia risk in dementia patients

NCT ID NCT03682081

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jul 16, 2026 · Updated 2 times

Summary

This study tested whether tongue-strengthening exercises using a special device could improve swallowing in people with Alzheimer's disease and related dementias. 76 participants with mild to moderate dementia did exercises over 8 weeks. The goal was to reduce food or liquid going into the lungs, which can cause pneumonia. Researchers measured changes in swallowing safety using video X-rays.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Iowa Oral Performance Instrument (IOPI) device for tongue strengthening exercises
What this could lead to
If successful, this could lead to a simple, non-drug therapy to help people with dementia swallow more safely and lower their risk of pneumonia.
What could go wrong
This is a small, completed study (76 participants) without a later phase, so results may not apply broadly. The exercises require active participation, which may be challenging for some with advanced dementia.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

76 people

The number who actually took part.

Started

Sep 2020

Finished

Nov 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

50 to 99 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion criteria (patients): * 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 Inclusion criteria (caregivers) * English speaking * Age 18 and older * Contact with patient at least 1 time a week * Has access to a working telephone Exclusion criteria (patients): * 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 Exclusion criteria (caregivers): * Lacks ability to give consent

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Conditions

The condition(s) this trial relates to.

Alzheimer disease Deglutition Disorders dementia

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • University of Wisconsin-Madison

    Madison, Wisconsin, 53705, United States

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