Assessing the gag reflex in healthy individuals and various patient groups
Prevalence of Gag Reflex in Healthy Persons and Across Different Patient Groups and Its Relevance in Dysphagia Screening
This study is testing how the gag reflex works in healthy people and those with certain neurological conditions to see if it affects their risk of choking while swallowing.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 700 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Giessen Academic / other |
| Locations | 1 site (Giessen, Hesse) |
| Trial ID | NCT04866251 on ClinicalTrials.gov |
What this trial studies
This study evaluates the prevalence of the gag reflex in healthy young and older individuals, as well as in patients with neurological conditions such as acute stroke, Parkinson's Disease, Myasthenia gravis, and Multiple Sclerosis. The research aims to determine the relationship between the gag reflex and the risk of aspiration during swallowing, particularly in dysphagic patients. Various oral areas will be tested for the gag reflex, and the Mallampati score will be assessed to understand the feasibility of testing in patients with higher scores. Each participant will undergo a single assessment by a trained examiner.
Who should consider this trial
Good fit: Ideal candidates include healthy individuals and patients with neurological diseases such as stroke, Parkinson's Disease, and Multiple Sclerosis.
Not a fit: Patients with pre-existing dysphagia, head and neck tumors, or those who have undergone certain surgeries may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve dysphagia screening and risk assessment for aspiration in patients with neurological conditions.
How similar studies have performed: Previous studies have shown varying prevalence rates of the gag reflex in healthy and dysphagic populations, indicating that this area of research has been explored but may still hold novel insights.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * informed consent Exclusion Criteria: 1. Healthy participants: Neurological diseases Pre-diagnosed dysphagia Percutaneous endoscopic gastrostomy (PEG) tube Head and neck tumours Chemo- and/or radiotherapy in the head and neck area Reflux disease Chronic obstructive pulmonary disease (COPD) Previous surgeries on the cervical spine or thyroid gland Vocal cord paresis 2. Geriatric patients Neurologic diseases 3. Stroke patients Head and neck tumours Chemo- and/or radiotherapy in the head and neck area Reflux disease COPD Previous surgeries on the cervical spine or thyroid gland Vocal cord paresis 4. Neurologic patients without stroke Head and neck tumours (except of intracranial tumors= Chemo- and/or radiotherapy in the head and neck area Reflux disease COPD Previous surgeries on the cervical spine or thyroid gland Vocal cord paresis
Where this trial is running
Giessen, Hesse
- University Hospital Giessen and Marburg — Giessen, Hesse, Germany (Recruiting)
Study contacts
- Principal investigator: Tobias Braun, MD — University Hospital Giessen and Marburg, Campus Giessen
- Study coordinator: Samra Hamzic, M.A.
- Email: samra.hamzic@neuro.med.uni-giessen.de
- Phone: +49 641 985 59233
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.