Prevalence of Gag Reflex in Healthy Persons and Across Different Patient Groups and Its Relevance in Dysphagia Screening

The aim of this study is to assess the prevalence of gag reflex in healthy young and healthy older subjects as well as in acute stroke patients, in patients with Parkinsons´s Disease, Myasthenia gravis, Multiple Sclerosis and in geriatric patients.

Study Overview

• Status: Recruiting
• Conditions: Neurological Diseases or Conditions
• Intervention / Treatment: Diagnostic test: Gag reflex test; assessment of Mallampati Score

Detailed Description

In the clinical swallowing examination in acute stroke setting it is assumed that the absence of gag reflex is a predictor of aspiration risk. According to Daniels et al. (1997) aspiration can be predicted with 96% sensitivity in case of absent or abnormal gag reflex. In clinical experience of investigators testing of gag reflex highly depends on patients´compliance and individual anatomical features such as Mallampati score. Furthermore, even if gag reflex is absent, swallowing does not have to be impaired.

The presence of gag reflex in healthy cohorts and dysphagic patients has been examined in a few studies. Davies et al. (1995) have shown that in 37% of healthy volunteers gag reflex was absent. Ramsey et al. (2005) have shown that approx. 89% of the patients without gag reflex had dysphagia and 31% without dysphagia had a gag reflex. In both studies it was not stated to what extent the gag reflex could be examined in case of a high Mallampati score.

The present study aims at assessing the prevalence of gag reflex in healthy and neurological cohorts. The study protocol foresees testing of gag reflex in different oral areas (tongue, velum, pharyngeal wall) and evaluating present reactions. The Mallampati score is assessed in order to evaluate the feasibility of gag reflex test in case of higher Mallampati scores.

All patients are tested once by one examiner.

• Study Type: Interventional
• Enrollment (Estimated): 700
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Samra Hamzic, M.A.; Phone Number: +49 641 985 59233; Email: samra.hamzic@neuro.med.uni-giessen.de

Study Locations

• Germany
  • Hessen
    • Gießen, Hessen, Germany, 35392
      • Recruiting
      • University Hospital Giessen and Marburg
      • Contact: Samra Hamzic, M.A.; Phone Number: +49 17699807230; Email: samra.hamzic@neuro.med.uni-giessen.de
      • Sub-Investigator: Samra Hamzic, M.A.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

7

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Healthy young subject; Testing of gag reflex in different oral areas (tongue, velum, pharyngeal wall) and evaluation of present reactions. The Mallampati score is assessed in order to evaluate the feasibility of gag reflex test in case of higher Mallampati scores.	Diagnostic test: Gag reflex test; assessment of Mallampati Score; Testing of gag reflex Assessment of Mallampati Score
Active Comparator: Healthy older subjects; Testing of gag reflex in different oral areas (tongue, velum, pharyngeal wall) and evaluation of present reactions. The Mallampati score is assessed in order to evaluate the feasibility of gag reflex test in case of higher Mallampati scores.	Diagnostic test: Gag reflex test; assessment of Mallampati Score; Testing of gag reflex Assessment of Mallampati Score
Active Comparator: Acute stroke patients; Testing of gag reflex in different oral areas (tongue, velum, pharyngeal wall) and evaluation of present reactions. The Mallampati score is assessed in order to evaluate the feasibility of gag reflex test in case of higher Mallampati scores.	Diagnostic test: Gag reflex test; assessment of Mallampati Score; Testing of gag reflex Assessment of Mallampati Score
Active Comparator: Patients with Parkinson´s Disease; Testing of gag reflex in different oral areas (tongue, velum, pharyngeal wall) and evaluation of present reactions. The Mallampati score is assessed in order to evaluate the feasibility of gag reflex test in case of higher Mallampati scores.	Diagnostic test: Gag reflex test; assessment of Mallampati Score; Testing of gag reflex Assessment of Mallampati Score
Active Comparator: Patients with Multiple Sclerosis; Testing of gag reflex in different oral areas (tongue, velum, pharyngeal wall) and evaluation of present reactions. The Mallampati score is assessed in order to evaluate the feasibility of gag reflex test in case of higher Mallampati scores.	Diagnostic test: Gag reflex test; assessment of Mallampati Score; Testing of gag reflex Assessment of Mallampati Score
Active Comparator: Patients with Myasthenia gravis; Testing of gag reflex in different oral areas (tongue, velum, pharyngeal wall) and evaluation of present reactions. The Mallampati score is assessed in order to evaluate the feasibility of gag reflex test in case of higher Mallampati scores.	Diagnostic test: Gag reflex test; assessment of Mallampati Score; Testing of gag reflex Assessment of Mallampati Score
Active Comparator: Geriatric patients; Testing of gag reflex in different oral areas (tongue, velum, pharyngeal wall) and evaluation of present reactions. The Mallampati score is assessed in order to evaluate the feasibility of gag reflex test in case of higher Mallampati scores.	Diagnostic test: Gag reflex test; assessment of Mallampati Score; Testing of gag reflex Assessment of Mallampati Score

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Prevalence of gag reflex	Prevalence of gag reflex	Baseline

Collaborators and Investigators

• Sponsor: University of Giessen
• Investigators: Principal Investigator: Tobias Braun, MD, University Hospital Giessen and Marburg, Campus Giessen

Study record dates

Study Major Dates

• Study Start (Actual): August 10, 2016
• Primary Completion (Estimated): February 1, 2024
• Study Completion (Estimated): February 1, 2024

Study Registration Dates

• First Submitted: November 18, 2020
• First Submitted That Met QC Criteria: April 27, 2021
• First Posted (Actual): April 29, 2021

Study Record Updates

• Last Update Posted (Estimated): December 1, 2023
• Last Update Submitted That Met QC Criteria: November 30, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases
• Other Study ID Numbers: Gag Reflex - 1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No