Effective Interventions to Overcome Severe Gag Reflex

Tufts University

Status and phase

Not yet enrolling

Early Phase 1

Conditions

Gagging

Treatments

Drug: Anesthetic spray

Device: Acupuncture

Genetic: Masking Tape

Study type

Interventional

Funder types

Other

Identifiers

NCT07099131

6213

Details and patient eligibility

About

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

Full description

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

Enrollment

45 estimated patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

45 participants in 3 patient groups

Acupuncture (CV-24)

Experimental group

Description:

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).

Treatment:

Device: Acupuncture

Tape

Experimental group

Description:

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

Treatment:

Genetic: Masking Tape

Anesthetic spray

Experimental group

Description:

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.