Effective Interventions to Overcome Severe Gag Reflex

NCT07099131 | Not Yet Recruiting Early Phase 1 FDA Drug FDA Device

• 1 other identifier: 6213
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the use of various techniques in alleviating gag reflex following gag reflex stimulation. Primary aim: To compare if there is any reduction in gag reflex from each of the following interventions

• Acupuncture (CV-24)
• Tape
• Anesthetic spray Secondary aim: to compare the degree of gag reduction

Conditions

Gagging

Outcome Measures

Primary Outcomes (1)

• Change in Gag Reflex Severity Index (GSI) Score From Pre- to Post-Intervention

  Change in Gag Reflex Severity Index (GSI) Score From Baseline to Post-Intervention * Acupuncture (CV-24) * Tape * Anesthetic spray Gag reflex severity will be assessed by clinicians using the Gagging Severity Index (GSI), based on definitions set by Dickinson and Fiske. GSI will first be recorded after initial gag stimulation with a cotton swab. Following randomization to one of three interventions (acupuncture, anesthetic spray, or masking tape), GSI will be recorded again. The change in GSI score will be used to measure change in gag response.

  90 minutes per subject

Secondary Outcomes (1)

• Self-Reported Degree of Gag Reflex Reduction Using Visual Analog Scale (VAS)

  Immediately post-intervention during single study visit

Study Arms (3)

Acupuncture (CV-24)

EXPERIMENTAL

A 6C file (endodontic instrumentation file) will be placed on the patient's mentolabial fold (CV24). This file will be concealed by a small paper cup; A clean alcohol wipe will be used to clean the mentolabial area prior to placing the "acupuncture needle" (6 C-File).

Device: Acupuncture

Tape

EXPERIMENTAL

A piece of commercially available masking tape will be adhered to the patient's mentolabial fold and concealed by the small paper cup

Genetic: Masking Tape

Anesthetic spray

EXPERIMENTAL

Will be applied to back of the throat for 10 seconds; their chin will also be concealed from the GSI examiner using a small cup and masking tape.

Drug: Anesthetic spray

Interventions

Anesthetic spray DRUG

will be applied to back of the throat for 10 seconds; their chin will also be concealed from the GSI examiner using a small cup and masking tape.

Anesthetic spray

Acupuncture DEVICE

A 6C file (endodontic instrumentation file) will be placed on the patient's mentolabial fold (CV24). This file will be concealed by a small paper cup; A clean alcohol wipe will be used to clean the mentolabial area prior to placing the "acupuncture needle" (6 C-File).

Acupuncture (CV-24)

Masking Tape GENETIC

A piece of commercially available masking tape will be adhered to the patient's mentolabial fold and concealed by the small paper cup

Tape

Eligibility Criteria

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

You may qualify if:

• years or older (individuals below 18 years will be excluded from the study as the study procedures might not be well tolerated by them, and they are not the primary population on which these procedures are used).
• Students, faculty, or staff of Tufts SDM
• Subjects who score a 2 or higher on the Gagging Severity Index (GSI)7 and have a positive gag reflex response when stimulated with a cotton swab at the base of the tongue/uvula/tonsil region.

You may not qualify if:

• Adults unable to consent (cognitively impaired adults)
• Wards of the state
• Pregnant women (those that are self-reported)
• Current use of anticoagulants
• Allergy to xylocaine
• Those with bleeding disorders
• Those who participated in the Calibration phase of this study

Sponsors & Collaborators

• Tufts University: lead

Study Sites (1)

Tufts University School of Dental Medicine

Boston, Massachusetts, 02111, United States

Location

MeSH Terms

Conditions

Gagging

Interventions

Acupuncture Therapy

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics

Study Officials

• Devon Ptak

  Tufts University School of Dental Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Devon Ptak

CONTACT

6176366889; devon.ptak@tufts.edu

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Unblinded. Subjects will be randomized. The three intervention groups are : Acupuncture (CV-24), Tape and Anesthetic Spray.

Study Record Dates

• First Submitted: July 8, 2025
• First Posted: August 1, 2025
• Study Start: December 7, 2025
• Primary Completion (Estimated): December 7, 2027
• Study Completion (Estimated): December 7, 2028
• Last Updated: August 1, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)