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NCT Number: NCT07099131

Effective Interventions to Overcome Severe Gag Reflex

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

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Key information

Conditions

Gagging Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Tufts University School of Dental Medicine

Boston, Massachusetts, 02111, United States

Location contact

Devon Ptak

CONTACT

[email protected]

6176366889

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 18 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.

Exclusion criteria

  • 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

Treatment and study plan

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.

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).

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

Primary outcomes

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

    Time frame: 90 minutes per subject

    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.

Secondary outcomes

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

    Time frame: Immediately post-intervention during single study visit

    Participants will complete an in-session survey to rate their gag reflex severity after the assigned intervention using a Visual Analog Scale (VAS). The VAS rating reflects the participant's perception of gag reduction following either acupuncture at CV24, anesthetic spray, or masking tape application.

Study contacts

Contact information is provided by the study sponsor or research team.

Devon Ptak

CONTACT

[email protected]

6176366889

Sponsors and collaborators

Lead sponsor

Tufts University

Other

Registry information

Important dates

Study start
2025
Primary completion
2027
Study completion
2028
First posted
Aug 1, 2025
Registry last updated
Aug 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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