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

NCT04866251 | Recruiting

• 1 other identifier: Gag Reflex - 1
• Study Type: interventional
• Target: 700
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Neurological Diseases or Conditions

Outcome Measures

Primary Outcomes (1)

• Prevalence of gag reflex

  Prevalence of gag reflex

  Baseline

Study Arms (7)

Healthy young subject

ACTIVE COMPARATOR

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

Healthy older subjects

ACTIVE COMPARATOR

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

Acute stroke patients

ACTIVE COMPARATOR

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

Patients with Parkinson´s Disease

ACTIVE COMPARATOR

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

Patients with Multiple Sclerosis

ACTIVE COMPARATOR

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

Patients with Myasthenia gravis

ACTIVE COMPARATOR

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

Geriatric patients

ACTIVE COMPARATOR

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

Interventions

Gag reflex test; assessment of Mallampati Score DIAGNOSTIC_TEST

Testing of gag reflex Assessment of Mallampati Score

Acute stroke patients; Geriatric patients; Healthy older subjects; Healthy young subject; Patients with Multiple Sclerosis; Patients with Myasthenia gravis; Patients with Parkinson´s Disease

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• informed consent

You may not qualify if:

• 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
• Geriatric patients Neurologic diseases
• 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
• 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

Sponsors & Collaborators

• University of Giessen: lead

Study Sites (1)

University Hospital Giessen and Marburg

Giessen, Hesse, 35392, Germany

RECRUITING

Study Officials

• Tobias Braun, MD

  University Hospital Giessen and Marburg, Campus Giessen

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Samra Hamzic, M.A.

CONTACT

+49 641 985 59233; samra.hamzic@neuro.med.uni-giessen.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 18, 2020
• First Posted: April 29, 2021
• Study Start: August 10, 2016
• Primary Completion: July 1, 2024
• Study Completion: July 1, 2024
• Last Updated: July 8, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)