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

March 15, 2026 updated by: Leona Möller, University Hospital Marburg
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

As part of a prospective controlled experimental intervention study, patients with ischemic stroke will be recruited in the Stroke Unit of the University Hospital Marburg, who are admitted between November 2024 and approximately October 2026. The primary objective of this study is to investigate the impact of a tongue brush (Orabrush) on the rate of aspiration pneumonia and dysphagia. Secondary outcomes include the analysis of bacterial tongue colonization, the Tongue Coating Index, and the length of stay of the patients. Key study parameters include the aspiration rate, the EAT-10, the GUSS, a tongue swab, and a photograph of the tongue to determine the Tongue Coating Index. Data will be collected on the day of admission and after a duration of 3-5 days. The study has been approved by the relevant ethics committee.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
252

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Germany
    • Hesse
      • Marburg, Hesse, Germany, 35043
        • University Hospital Marburg

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
No Intervention: Routine Care Group
Patients in the Routine Care Group receive standard speech therapy during their inpatient stay.
Experimental: Tongue Brush Group
Patients in the Tongue Brush Group receive standard speech therapy and additionally use the tongue brush twice daily for a period of 3-5 days during their inpatient stay.
Device: Tongue Brush (Orabrush)
Patients in this group uses the Tongue Brush (Orabrush) 2 times a day for a duration for 3-5 days until the follow-up-screening takes place.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Rate of Aspiration Pneumonias
Time Frame: 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.
Evaluation of the Impact of a Tongue Brush on the Incidence of Aspiration Pneumonia in Patients with Ischemic Stroke.
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]
Time Frame: EAT-10 is assessed on the day of admission and after a period of 3-5 days.
This study aims to investigate whether the use of a tongue brush has an effect on the severity of dysphagia in ischemic stroke patients compared to the control group. The severity of dysphagia is quantified using the dysphagia screening tool EAT-10. The EAT-10 can have a score ranging from 0 to 40, with the severity of dysphagia increasing as the score rises.
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]
Time Frame: GUSS is assessed on the day of admission and after a period of 3-5 days.
This study aims to investigate whether the use of a tongue brush has an effect on the severity of dysphagia in ischemic stroke patients compared to the control group. The severity of dysphagia is quantified using the dysphagia screening tool GUSS. The GUSS can have a score ranging from 0 to 20, with the severity of dysphagia increasing as the score decreases.
GUSS is assessed on the day of admission and after a period of 3-5 days.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Winkel Tongue Coating Index [Score from 0 to 12]
Time Frame: The WTCI of the patients is determined on the day of admission and after 3-5 days.
Determination of the Winkel Tongue Coating Index (WTCI) in ischemic stroke patients. For this purpose, the tongue is divided into six equal-sized quadrants, and each quadrant is assigned a score from 0 to 2, depending on the severity of tongue coating. In total, a score ranging from a minimum of 0 to a maximum of 12 points can be achieved across the six quadrants. A low score indicates very little tongue coating, while a high score reflects a significant amount of tongue coating.
The WTCI of the patients is determined on the day of admission and after 3-5 days.
Microbiological quantification of the tongue's bacterial load through the determination of colony-forming units (CFU)
Time Frame: Bacterial tongue colonization is assessed in the patients through swabbing on the day of admission and after 3-5 days.
A swab of the tongue is taken from patients with ischemic stroke, and a microbiological quantification of the bacterial load is performed. Depending on the level of CFU, the bacterial load is categorized into the semiquantitative parameters 'low,' 'moderate,' and 'high'.
Bacterial tongue colonization is assessed in the patients through swabbing on the day of admission and after 3-5 days.
Length of in-hospital stay in days
Time Frame: Duration of in-hospital stay, measured from the admission date to the discharge date, during the inpatient treatment period. The average length of stay is approximately 6 days, so a maximum time frame of 30 days is chosen for the survey.
It is investigated how many days patients with ischemic stroke stay in the hospital and whether there is a significant difference in the length of stay between the control and intervention groups.
Duration of in-hospital stay, measured from the admission date to the discharge date, during the inpatient treatment period. The average length of stay is approximately 6 days, so a maximum time frame of 30 days is chosen for the survey.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University Hospital Marburg

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 31, 2026

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 31, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 27, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 2, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 9, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 17, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 15, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 23-227 BO

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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