RecruitingOBSERVATIONAL

BJH-SDS Validation of the German Translation

This research is looking at a German translation of a quick screening test called the Barnes-Jewish Hospital Stroke Dysphagia Screen (BJH-SDS). Swallowing difficulties (dysphagia) are common after a stroke and can lead to serious problems like lung infections. This study wants to confirm that the German version of this test is accurate and reliable in spotting these swallowing problems early on, not just in stroke patients but potentially in other neurological patients too. By accurately identifying those at risk, doctors can provide the right support sooner and prevent further complications. The study will also see if different healthcare professionals get similar results when using the test.

At a glance

Status

Recruiting

Sponsor

University of Giessen

Enrolment target

570

Start

15 Apr 2024

Estimated completion

01 May 2026

Dysphagia Stroke, Acute

What is this study about?

When someone has a stroke, it can sometimes affect their ability to swallow properly. This is called dysphagia, and it's quite common, affecting about half of all stroke patients in the early stages. If not detected, swallowing problems can lead to serious health issues, such as food or drink going down the wrong way into the lungs, which can cause severe lung infections. These infections can be life-threatening and lead to other problems like not getting enough nutrients or becoming dehydrated.

To help prevent these serious complications, doctors use special tests to check for swallowing problems. One such test is the Barnes-Jewish Hospital Stroke Dysphagia Screen (BJH-SDS), which is quick and has been shown to be good at identifying patients at risk. However, this test is currently not available in German. This study aims to translate the BJH-SDS into German and then carefully check if this new German version works just as well as the original.

Researchers want to make sure the German test accurately identifies patients who have swallowing problems and also correctly shows who doesn't. They'll also check if different healthcare professionals get similar results when using the test. If this German version proves to be reliable, it could help doctors in Germany spot swallowing difficulties in stroke patients more quickly, leading to better care and fewer complications. They might even test it on other patients with neurological conditions later.

Key takeaways

The study tests a German version of a quick swallowing screener after stroke.
It aims to prevent serious lung infections caused by swallowing difficulties.
Participation involves a simple swallowing test and possibly a camera examination (FEES).
Results could help doctors identify stroke patients at risk more quickly.
You can stop participating at any time without affecting your care.

Who may be eligible?

This study is looking for adult patients between 18 and 100 years old, both men and women, who have recently had a stroke and are being cared for in a neurology department.

You would not be able to join this study if you can't give your clear permission to take part. Also, if you have certain medical conditions that would make a special swallowing camera test (called FEES) unsafe for you, or if you had a stroke before, already had swallowing problems, or have another illness known to affect swallowing (like certain ear, nose, and throat conditions or Parkinson's disease), you would not be able to participate.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you between 18 and 100 years old?
Have you recently had a stroke?
Are you able to give your clear permission to participate?
Do you NOT have an existing medical condition that affects swallowing (like an old stroke or Parkinson's)?
Are there no reasons your doctor would advise against a special swallowing camera test (FEES)?

Answer every question to see your result.

What does participation involve?

If you are eligible and agree to take part, the study involves being screened with the new German swallowing test (BJH-SDS-G). This is a quick test where a healthcare professional will check your alertness, facial movements, and then ask you to swallow a small amount of water if everything else seems normal. To confirm the results of this new test, you will also undergo a more detailed examination called a Flexible Endoscopic Evaluation of Swallowing (FEES). This involves a thin, flexible tube with a camera being gently passed through your nose to observe your swallowing. The study does not involve taking any new medications. The exact number of visits or the total duration of your participation is not specified but appears to be limited to these initial assessments during your hospital stay.

Potential risks and benefits

A potential benefit of taking part is contributing to research that could improve how swallowing problems are identified and managed for future stroke patients. The special FEES test you might have is a standard medical procedure, but like any medical assessment, there are minimal risks such as temporary discomfort or gagging. The water swallow test is generally very safe. You are free to withdraw from the study at any time without giving a reason, and this will not affect your medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

University Hospital Giessen and Marburg, Campus Giessen
City only
Giesen, Germany· Recruiting

Common questions

What is dysphagia?

Dysphagia means having difficulty swallowing. It can happen after a stroke and makes it hard to safely eat or drink.

What is the BJH-SDS test?

It's a quick and simple test used by healthcare professionals to check if someone might have problems swallowing after a stroke.

What is a FEES examination?

FEES is a special camera test where a tiny camera goes through your nose to look at your throat while you swallow, helping doctors see exactly what's happening.

Why is this study important?

This study helps make sure the German version of the swallowing test is accurate, so doctors can quickly find and help patients with swallowing problems, preventing serious complications.

Will I get special treatment if I join?

You will receive the standard care for your stroke, and by participating, you help researchers learn more about improving screening for swallowing issues for everyone.

How to find out more

Tobias Braun, PD MD

tobias.braun@neuro.med.uni-giessen.de +49 6441793517 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.