GaggingEarly Phase 1NCT07099131
Effective Interventions to Overcome Severe Gag Reflex
A Early Phase 1 study testing Anesthetic spray, Acupuncture and Masking Tape in people with Gagging, run by Tufts University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Gagging
- What is being tested?
- Anesthetic spray, Acupuncture and Masking Tape
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Dec 2025to 7 Dec 2028
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Tufts University School of Dental Medicine
Boston, Massachusetts, 02111
Devon Ptak, 6176366889, devon.ptak@tufts.edu
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
Read the detailed 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
- Conditions
- Gagging
- Being tested
- Anesthetic spray, Acupuncture, Masking Tape
- Medical subject headings
- Gagging
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anesthetic sprayDrug
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.
AcupunctureDevice
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 TapeGenetic
A piece of commercially available masking tape will be adhered to the patient's mentolabial fold and concealed by the small paper cup
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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 Receives: 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. Receives: Drug: Anesthetic spray |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 90 minutes per subject
Secondary outcomes (1)
Self-Reported Degree of Gag Reflex Reduction Using Visual Analog Scale (VAS)
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.
Measured: Immediately post-intervention during single study visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2025
- Study start7 Dec 2025 (estimated)
- Primary completion7 Dec 2027 (estimated)
- Study completion7 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GaggingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Unblinded. Subjects will be randomized. The three intervention groups are : Acupuncture (CV-24), Tape and Anesthetic Spray.
- Masking
- None (open label)
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tufts University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Devon Ptak, Principal investigator, Tufts University School of Dental Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07099131
- Sponsor's protocol ID
- 6213
- Status last verified
- Jul 2025
- First submitted
- 8 Jul 2025
- Last updated
- 1 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effective Interventions to Overcome Severe Gag Reflex
- ClinicalTrials.gov ID
- NCT07099131
- Acronym / sponsor ID
- 6213
- Conditions
- Gagging
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Tufts UniversityUniversity, hospital or other
- Study start
- 7 Dec 2025 (estimated)
- Primary completion
- 7 Dec 2027 (estimated)
- Study completion
- 7 Dec 2028 (estimated)
- First posted
- 1 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed 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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Unblinded. Subjects will be randomized. The three intervention groups are : Acupuncture (CV-24), Tape and Anesthetic Spray.
| Arm | Type | Receives |
|---|---|---|
| Acupuncture (CV-24) | Experimental | Device: AcupunctureA 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). |
| Tape | Experimental | Genetic: Masking TapeA piece of commercially available masking tape will be adhered to the patient's mentolabial fold and concealed by the small paper cup |
| Anesthetic spray | Experimental | Drug: Anesthetic sprayWill 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Anesthetic spraywill 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 |
| AcupunctureA 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 (CV-24) |
| Masking TapeA piece of commercially available masking tape will be adhered to the patient's mentolabial fold and concealed by the small paper cup | Genetic | Tape |
Primary outcome
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.
1 secondary outcome
Self-Reported Degree of Gag Reflex Reduction Using Visual Analog Scale (VAS)
Time frame: Immediately post-intervention during single study visit
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2025.
- Individual participant dataSharing planned: No
Related trials for Gagging
Recruiting
Acupuncture Mechanism in Relief of Gag Reflex
Gag (Pharyngeal) Reflex
Not yet recruiting
Mucoadhesive Gels in Controlling Gag Reflex Among Children During Dental Radiographic Examination
Gag Reflex, Child
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Devon Ptak principal investigator
Tufts University School of Dental Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Anesthetic spray, Acupuncture and Masking Tape in people with Gagging, run by Tufts University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 1 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Devon Ptak (6176366889, devon.ptak@tufts.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Gag Reflex Severity Index (GSI) Score From Pre- to Post-Intervention (time frame: 90 minutes per subject). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Aug 2025.