Dysphagia After StrokeStrOraNCT06765018
Tongue Brush (Orabrush) for Reducing Aspiration Pneumonia in Stroke Patients
A study testing Tongue Brush (Orabrush) in people with Dysphagia After Stroke and Aspiration Pneumonias, run by University Hospital Marburg at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dysphagia After Stroke, Aspiration Pneumonias, Ischemic Stroke
- What is being tested?
- Tongue Brush (Orabrush)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 252 participants
- Where
- 1 siteGermany
- Study dates
- 1 Nov 2024to 31 Jan 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Being tested
- Tongue Brush (Orabrush)
- Keywords
- Dysphagia after stroke, Aspiration Pneumonias, Tongue Coating Index, Bacterial Tongue Colonization, Ischemic Stroke
- Medical subject headings
- Pneumonia, Aspiration, Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tongue Brush (Orabrush)Device
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.
| Study group | Role | What they receive |
|---|---|---|
| Routine Care Group | No intervention | Patients in the Routine Care Group receive standard speech therapy during their inpatient stay. |
| Tongue Brush Group | Experimental | 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. Receives: Device: Tongue Brush (Orabrush) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of Aspiration Pneumonias
Evaluation of the Impact of a Tongue Brush on the Incidence of Aspiration Pneumonia in Patients with Ischemic Stroke.
Measured: 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]
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.
Measured: 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]
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.
Measured: GUSS is assessed on the day of admission and after a period of 3-5 days.
Secondary outcomes (3)
Winkel Tongue Coating Index [Score from 0 to 12]
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.
Measured: 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)
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'.
Measured: 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
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.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2025
- Study start1 Nov 2024
- Primary completion31 Jan 2026
- Study completion31 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dysphagia After StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 252 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Marburg
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Leona Möller, University Hospital Marburg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06765018
- Sponsor's protocol ID
- 23-227 BO
- Acronym
- StrOra
- Status last verified
- Mar 2026
- First submitted
- 27 Nov 2024
- Last updated
- 17 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tongue Brush (Orabrush) for Reducing Aspiration Pneumonia in Stroke Patients
- ClinicalTrials.gov ID
- NCT06765018
- Acronym / sponsor ID
- StrOra / 23-227 BO
- Keywords
- Dysphagia after stroke, Aspiration Pneumonias, Tongue Coating Index, Bacterial Tongue Colonization, Ischemic Stroke
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 252 participants (actual)
- Lead sponsor
- University Hospital MarburgUniversity, hospital or other
- Study start
- 1 Nov 2024 (actual)
- Primary completion
- 31 Jan 2026 (actual)
- Study completion
- 31 Jan 2026 (actual)
- First posted
- 9 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Routine Care Group | No intervention | –Patients in the Routine Care Group receive standard speech therapy during their inpatient stay. |
| Tongue Brush Group | Experimental | Device: Tongue Brush (Orabrush)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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | Tongue Brush Group |
Primary outcome
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.
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.
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.
3 secondary outcomes
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2026.
- Individual participant dataSharing planned: No
Related trials for Dysphagia After Stroke
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
Not yet recruiting
EEG Feedback-Based Vagus Nerve Stimulation for Post-Stroke Dysphagia
Ischemic Stroke, Post-stroke Dysphagia
Not yet recruiting
Dentate-Targeted Temporal Interference Stimulation for Post-Stroke Dysphagia
Deglutition Disorders, Ischemic Stroke
Not yet recruiting
Deep Brain Stimulation + Therapy for Stroke
Stroke, Dysarthria
Not yet recruiting
Combined Acupuncture-Based Therapy for Rehabilitation After Ischemic Stroke
Ischemic Stroke, Hemiplegia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tongue Brush (Orabrush) in people with Dysphagia After Stroke and Aspiration Pneumonias, run by University Hospital Marburg at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2026.