CompletedNot Applicable

Tongue Brush (Orabrush) for Reducing Aspiration Pneumonia in Stroke Patients

Germany252 participantsStarted 2024-11-01

Plain-language summary

The investigators conduct a controlled prospective experimental intervention study to examine whether the use of a tongue brush (Orabrush) can improve the rate of aspiration pneumonia and dysphagia in patients with ischemic stroke. Secondary outcomes include the impact on bacterial tongue colonization, the Tongue Coating Index, and the length of stay of the patients.The patients will be recruited in the Stroke Unit of the Department of Neurology from November 2024 until approximately October 2026.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * ischemic stroke and admission on the stroke unit at the University Hospital Marburg * minimum age: 18 years * patient is able to consent * consent has been obtained Exclusion Criteria: * surgery in the oral-pharyngeal region * irradiated patient with a history of tumor in the head and neck region * missing compliance * intake of medications with saliva-altering side effects, existing desire to have children, or pregnancy

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Rate of Aspiration Pneumonias

Timeframe: From the date of first admission until discharge, with the occurrence of aspiration, within max. 4 weeks pneumonia documented at any point during the inpatient stay.

Severity of dysphagia measured by EAT-10 [score from 0-40]

Timeframe: EAT-10 is assessed on the day of admission and after a period of 3-5 days.

Severity of dysphagia measured by GUSS [score from 0-20]

Timeframe: GUSS is assessed on the day of admission and after a period of 3-5 days.

Trial details

NCT IDNCT06765018

SponsorUniversity Hospital Marburg

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-01-31

View on ClinicalTrials.gov More Dysphagia After Stroke trials