GaggingNCT04757948
Acupuncture vs TENS for Gag Reflex
A study testing Acupuncture and TENS in people with Gagging, run by University of California, Los Angeles at 1 site in United States.
Trial summary
This study examines if acupuncture or TENS of P-6 and St-36 acupoints has a measurable effect on gag tolerance. Read more about this study
- Who is it for?
- Ages 18 to 89 yearsHealthy volunteers can take part
- Conditions the study is for
- Gagging
- What is being tested?
- Acupuncture and TENS
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Jun 2018to 30 Jan 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 89 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- English Speaking
Who cannot join
- bleeding dyscrasias
- severe needlephobia
- pacemaker or other implanted electrical device
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, Los Angeles
Los Angeles, California, 90095
About this study
This study examines if acupuncture or TENS of P-6 and St-36 acupoints has a measurable effect on gag tolerance.
Read the detailed description
The gag reflex is a normal protective mechanism, and portion of the population has an exaggerated reflex that can present major problems in dentistry as well as endoscopy. Early studies with acupuncture have been promising, but these studies are limited as has not been a way to objectively measure the response to gag reflex. Recent work by Drs. Karibe and Goddard has determined a novel way of measuring gag reflex in healthy subjects, which makes it possible to study the effects of an intervention on gag reflex.
Acupuncture has been demonstrated to be effective for treating gag reflex, but this effect has not been objectively demonstrated using this novel method. As such, this study investigates the effect of acupuncture against placebo on gag reflex. Practically speaking, these findings are unlikely to be of high value since the availability of acupuncturists at dental offices is limited. For this reason, the investigators added a third arm to evaluate the use of a transcutaneous electrical nerve stimulator (TENS) device on the same acupuncture points as a treatment intervention to see if this is non-inferior to acupuncture. TENS is an FDA regulated treatment for the treatment of pain, and has been 510K cleared for other uses including nausea. The placebo arm uses a TENS device that has the wire severed, so that the light will continue to blink but no current will be applied.
60 total subjects will be recruited and randomized into one of these three groups: acupuncture, TENS and Sham-TENS.
Passive EKG readings will be collected using the FirstBeat Bodyguard 2, which is a 2-lead EKG device that the subject will wear during the study. This is to later evaluate vagal tone by analyzing the spectral analysis of heart rate variability.
Once this device is affixed to the front of the patient's chest, the gag reflex will be measured. The subject will then undergo the appropriate treatment (acupuncture, TENS or Sham-TENS for a total of 20 minutes, with a subsequent gag reflex measurement. The subject will then rest for at least 5 minutes at the end of the study to collect final EKG data, then given a gift card for her time.
It is the hypothesis of the investigators that the treatments will increase gag tolerance in the following stepwise manner: Sham-TENS < TENS < Acupuncture
- Conditions
- Gagging
- Being tested
- Acupuncture, TENS, Sham-TENS
- Keywords
- acupuncture, TENS, acupressure, acupoint, gag
- Medical subject headings
- Gagging
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcupunctureProcedure or surgery
Acupuncture of acupoints P-6 and St-36
TENSDevice
TENS of acupoints P-6 and St-36
Sham-TENSDevice
Sham-TENS of acupoints P-6 and St-36
| Study group | Role | What they receive |
|---|---|---|
| Acupuncture | Experimental | Sterile needles are inserted into acupuncture points P-6 and St-36 bilaterally and retained for a total of 20 minutes. Halfway through the treatment, the needles are manipulated in order to re-create the acupuncture sensation. The needles are removed after 20 minutes of treatment prior to the second gag measurement. Receives: Procedure: Acupuncture |
| TENS | Experimental | Gel pads are affixed to the acupuncture points P-6 and St-36, bilaterally. The amplitude of the TENS device will be gradually increased up to a maximum setting of 8/10, with the subject asked to notify the examiner as soon as any sensation is noticed. Once a gentle buzzing sensation is noticed, the amplitude will be reduced slightly for comfort and then the device will remain for the duration of 20 minutes. The pads are then removed prior to the second gag reflex measurement. Receives: Device: TENS |
| Sham-TENS | Placebo comparator | For the sham-TENS group, the protocol is identical to the TENS group, however the electrical wires have been severed and re-attached in the control unit. As such, the unit will flash a light but there will be no current delivered. The subject is told that no sensation is required. The amplitude will be turned up to a maximum setting of 8/10 and left there for 20 minutes, then the device turned off and pads removed. Receives: Device: Sham-TENS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Insertion length
A standard saliva ejector with a stopper made of heavy-body addition silicone impression putties is inserted into the participants' mouth at the maxillary central incisor, and gradually guided down the participant's throat along the palate. The participants are asked to inform the examiner when their maximum tolerance has been reached by pushing a button that beeps. The examiner then stopped inserting the saliva ejector, remove it, and measure the insertion distance of the saliva ejector from the maxillary central incisor using digital calipers. This distance is recorded as an index of the gag reflex.
Measured: immediately after procedure
Severity of gag reflex
Subjects are also be asked to report the severity of their gagging on a scale of 1-10, with 1 representing the minimum and 10 representing the maximum
Measured: immediately after procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2021
- Study start13 Jun 2018
- Primary completion30 Jan 2020
- Study completion30 Jan 2020
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.
- More trials run by University of California, Los AngelesThe sponsor's other registered studies.
- 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
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andrew Shubov, MD, University of California, Los Angeles
- Investigators
- Andrew Shubov, MD, Principal investigator, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04757948
- Sponsor's protocol ID
- IRB#18-000473
- Status last verified
- Feb 2021
- First submitted
- 3 Feb 2021
- Last updated
- 17 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acupuncture vs TENS for Gag Reflex
- ClinicalTrials.gov ID
- NCT04757948
- Acronym / sponsor ID
- IRB#18-000473
- Conditions
- Gagging
- Keywords
- acupuncture, TENS, acupressure, acupoint, gag
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Study start
- 13 Jun 2018 (actual)
- Primary completion
- 30 Jan 2020 (actual)
- Study completion
- 30 Jan 2020 (actual)
- First posted
- 17 Feb 2021 (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.
This study examines if acupuncture or TENS of P-6 and St-36 acupoints has a measurable effect on gag tolerance.
Detailed description
The gag reflex is a normal protective mechanism, and portion of the population has an exaggerated reflex that can present major problems in dentistry as well as endoscopy. Early studies with acupuncture have been promising, but these studies are limited as has not been a way to objectively measure the response to gag reflex. Recent work by Drs. Karibe and Goddard has determined a novel way of measuring gag reflex in healthy subjects, which makes it possible to study the effects of an intervention on gag reflex.
Acupuncture has been demonstrated to be effective for treating gag reflex, but this effect has not been objectively demonstrated using this novel method. As such, this study investigates the effect of acupuncture against placebo on gag reflex. Practically speaking, these findings are unlikely to be of high value since the availability of acupuncturists at dental offices is limited. For this reason, the investigators added a third arm to evaluate the use of a transcutaneous electrical nerve stimulator (TENS) device on the same acupuncture points as a treatment intervention to see if this is non-inferior to acupuncture. TENS is an FDA regulated treatment for the treatment of pain, and has been 510K cleared for other uses including nausea. The placebo arm uses a TENS device that has the wire severed, so that the light will continue to blink but no current will be applied.
60 total subjects will be recruited and randomized into one of these three groups: acupuncture, TENS and Sham-TENS.
Passive EKG readings will be collected using the FirstBeat Bodyguard 2, which is a 2-lead EKG device that the subject will wear during the study. This is to later evaluate vagal tone by analyzing the spectral analysis of heart rate variability.
Once this device is affixed to the front of the patient's chest, the gag reflex will be measured. The subject will then undergo the appropriate treatment (acupuncture, TENS or Sham-TENS for a total of 20 minutes, with a subsequent gag reflex measurement. The subject will then rest for at least 5 minutes at the end of the study to collect final EKG data, then given a gift card for her time.
It is the hypothesis of the investigators that the treatments will increase gag tolerance in the following stepwise manner: Sham-TENS < TENS < Acupuncture
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Acupuncture | Experimental | Procedure: AcupunctureSterile needles are inserted into acupuncture points P-6 and St-36 bilaterally and retained for a total of 20 minutes. Halfway through the treatment, the needles are manipulated in order to re-create the acupuncture sensation. The needles are removed after 20 minutes of treatment prior to the second gag measurement. |
| TENS | Experimental | Device: TENSGel pads are affixed to the acupuncture points P-6 and St-36, bilaterally. The amplitude of the TENS device will be gradually increased up to a maximum setting of 8/10, with the subject asked to notify the examiner as soon as any sensation is noticed. Once a gentle buzzing sensation is noticed, the amplitude will be reduced slightly for comfort and then the device will remain for the duration of 20 minutes. The pads are then removed prior to the second gag reflex measurement. |
| Sham-TENS | Placebo comparator | Device: Sham-TENSFor the sham-TENS group, the protocol is identical to the TENS group, however the electrical wires have been severed and re-attached in the control unit. As such, the unit will flash a light but there will be no current delivered. The subject is told that no sensation is required. The amplitude will be turned up to a maximum setting of 8/10 and left there for 20 minutes, then the device turned off and pads removed. |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- English Speaking
Key exclusion criteria (3 listed)
- bleeding dyscrasias
- severe needlephobia
- pacemaker or other implanted electrical device
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 |
|---|---|---|
| AcupunctureAcupuncture of acupoints P-6 and St-36 | Procedure or surgery | Acupuncture |
| TENSTENS of acupoints P-6 and St-36 | Device | TENS |
| Sham-TENSSham-TENS of acupoints P-6 and St-36 | Device | Sham-TENS |
Primary outcome
Insertion length
Time frame: immediately after procedure
A standard saliva ejector with a stopper made of heavy-body addition silicone impression putties is inserted into the participants' mouth at the maxillary central incisor, and gradually guided down the participant's throat along the palate. The participants are asked to inform the examiner when their maximum tolerance has been reached by pushing a button that beeps. The examiner then stopped inserting the saliva ejector, remove it, and measure the insertion distance of the saliva ejector from the maxillary central incisor using digital calipers. This distance is recorded as an index of the gag reflex.
Severity of gag reflex
Time frame: immediately after procedure
Subjects are also be asked to report the severity of their gagging on a scale of 1-10, with 1 representing the minimum and 10 representing the maximum
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2021.
- Individual participant dataSharing planned: Undecided
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
Not yet recruitingEarly Phase 1
Effective Interventions to Overcome Severe Gag Reflex
Gagging
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. This study is not recruiting at the moment.
Andrew Shubov, MD principal investigator
University of California, Los Angeles
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acupuncture and TENS in people with Gagging, run by University of California, Los Angeles 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 1 inclusion and 3 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: finished, as of the sponsor's last update on 17 Feb 2021. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Insertion length (time frame: immediately after procedure). The study lists 2 primary outcomes in all. 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 17 Feb 2021.