Acupuncture Mechanism in Relief of Gag Reflex | NCT07664826

Studies
Acupuncture Mechanism in Relief of Gag Reflex

NCT07664826

Sponsor

University Medicine Greifswald

Status

Recruiting

Last Update Posted

Jun 24, 2026Actual

Enrollment

30Estimated

Phase

Not Applicable

Conditions

Gag (Pharyngeal) Reflex

Interventions

Acupuncture

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
BB150/25	Other Identifier	Ethics Commission of the University Medicine of Greifswald

Status Module

Record Verification Date

Jun 2026

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 21, 2026Actual

Primary Completion Date

Aug 2026Estimated

Completion Date

Aug 2026Estimated

First Submitted Date

Jun 8, 2026

First Submission Date that Met QC Criteria

Jun 23, 2026

First Posted Date

Jun 24, 2026Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 23, 2026

Last Update Posted Date

Jun 24, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The gag reflex relief effect of acupuncture of CV24 acupoint will be compared to acupuncture of PC6 and K3 acupoints in healthy volunteers in crossover mode. Second step will be the investigation whether local anesthesia using EMLA creme will block the gag relief effect of CV24 acupuncture in healthy volunteers.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

30Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
CV24	Experimental	Needling of acupoint PC6	Other: Acupuncture
PC6	Active Comparator	Needling of acupoint PC6	Other: Acupuncture
K3	Active Comparator	Needling of acupoint K3	Other: Acupuncture

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Acupuncture	Other	Needling of acupoints CV24, PC6 and K3	CV24 K3 PC6

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Length of saliva injector insertion (cm)	Saliva injector is inserted intraoral slowly until the gagging (pharyngeal reflex) is elicited; the length of insertion of saliva injector will be measured in centimeters	Day 1 ( before and after acupuncture)

Secondary Outcomes

Measure	Description	Time Frame
Severity of gagging, measured using the Numeric Rating Scale NRS-11 (0=no gagging; 10=maximal)		Day 1 ( before and after acupuncture)

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Healthy volunteers aged between 20-40 years old with an American Society of Anesthesiologists physical status of I to II naïve to acupuncture
Participants without previous opioid and psychotropic medication
Without use of recreational drugs 3 days prior to study sessions
Without systemic disease or local skin lesions at the sites of acupuncture
Without drug allergy to local anesthetics, especially EMLA preparation
Participants who have given written informed consent

Exclusion Criteria:

Local skin infection at the sites of acupuncture
Aged < 20 or > 35 years
History of drug allergy to local anesthetics
Participants who are unable to understand the consent form or to use numeric rating scale NRS-11

Discontinuation Criteria

Any adverse effects during study session
In case of local or systemic infection
In case if subject will withdraw from participation in this study at any time, for any reason, specified or non-specified, and without penalty or loss of benefits

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

40 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Taras I Usichenko, Prof. Dr. med., MD, PhD	Contact	+49 (0) 3434864028		tarasik@me.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Medicine of Greifswald	Recruiting	Greifswald		17475	Germany

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

Corresponding author will share the anonymized, statistically calculated data on request after publication of the results

Types

Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)

Time Frame

After publication of study results

Access Criteria

On request via email contact to the corresponding author

URL

Not provided

ID	Term
D000529	Complementary Therapies
D013812	Therapeutics