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

NCT ID: NCT06765018

Last Updated: 2025-01-09

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 383 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-11-01
• Study Completion Date: 2027-04-01

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.

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.

Conditions

Dysphagia After Stroke; Aspiration Pneumonias; Ischemic Stroke

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Routine Care Group

Patients in the Routine Care Group receive standard speech therapy during their inpatient stay.

Group Type: NO_INTERVENTION

No interventions assigned to this group

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.

Group Type: EXPERIMENTAL

Tongue Brush (Orabrush)

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital Marburg

OTHER

Sponsor Role: lead

Responsible Party

Leona Möller

Leona Möller, MD; Principal Investigator, Consultant in Neurology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University Hospital Marburg

Marburg, Hesse, Germany

Site Status: RECRUITING

Countries

Germany

Central Contacts

Leona Möller, MD

Role: CONTACT

leona.moeller@med.uni-marburg.de

+4964215865348

Facility Contacts

Leona Möller, MD

Role: primary

leona.moeller@med.uni-marburg.de

+4964215865348

Other Identifiers

23-227 BO

Identifier Type: -

Identifier Source: org_study_id