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Completed

NCT Number: NCT04757948

Acupuncture vs TENS for Gag Reflex

This study examines if acupuncture or TENS of P-6 and St-36 acupoints has a measurable effect on gag tolerance.

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Key information

Conditions

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

Age range

18 year–89 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of California, Los Angeles

Los Angeles, California, 90095, United States

About this study

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

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • English Speaking

Exclusion criteria

  • bleeding dyscrasias
  • severe needlephobia
  • pacemaker or other implanted electrical device

Treatment and study plan

Acupuncture

Procedure

Acupuncture of acupoints P-6 and St-36

TENS

Device

TENS of acupoints P-6 and St-36

Sham-TENS

Device

Sham-TENS of acupoints P-6 and St-36

Primary outcomes

  1. 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.

  2. 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

Sponsors and collaborators

Lead sponsor

University of California, Los Angeles

Other

Registry information

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Feb 17, 2021
Registry last updated
Feb 17, 2021

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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