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

NCT06765018 | Completed

• 1 other identifier: 23-227 BO
• Study Type: interventional
• Target: 252
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Ischemic Stroke; Dysphagia After Stroke; Aspiration Pneumonias

Keywords

Dysphagia after stroke; Aspiration Pneumonias; Tongue Coating Index; Bacterial Tongue Colonization; Ischemic Stroke

Outcome Measures

Primary Outcomes (3)

• Rate of Aspiration Pneumonias

  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]

  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]

  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 Outcomes (3)

• Winkel Tongue Coating Index [Score from 0 to 12]

  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)

  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

  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.

Study Arms (2)

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.

Device: Tongue Brush (Orabrush)

Interventions

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.

Tongue Brush Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital Marburg: lead

Study Sites (1)

University Hospital Marburg

Marburg, Hesse, 35043, Germany

Location

MeSH Terms

Conditions

Pneumonia, Aspiration; Ischemic Stroke

Condition Hierarchy (Ancestors)

Pneumonia; Respiratory Tract Infections; Infections; Lung Diseases; Respiratory Tract Diseases; Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Leona Möller, MD; Principal Investigator, Consultant in Neurology

Study Record Dates

• First Submitted: November 27, 2024
• First Posted: January 9, 2025
• Study Start: November 1, 2024
• Primary Completion: January 31, 2026
• Study Completion: January 31, 2026
• Last Updated: March 17, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)