Functional Dyspepsia Treatment Using Virtual Reality

NCT ID: NCT05836597

Last Updated: 2026-01-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-04-01

Study Completion Date

2026-12-31

Brief Summary

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The purpose of this study is to evaluate the effectiveness of using virtual reality to treat gastrointestinal symptoms related to functional dyspepsia.

Detailed Description

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Conditions

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Functional Dyspepsia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Experimental

Experimental VR

Group Type EXPERIMENTAL

Virtual reality

Intervention Type DEVICE

Virtual reality

Sham

Sham VR

Group Type SHAM_COMPARATOR

Virtual reality

Intervention Type DEVICE

Virtual reality

Interventions

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Virtual reality

Virtual reality

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Symptoms of dyspepsia thought to represent functional dyspepsia, meeting Rome IV criteria
* Had an upper endoscopy and assessment for Helicobacter pylori; if a patient is found to have H. pylori, treatment with confirmed eradication (by stool antigen test or urea breath test) will be required before the patient is eligible for study inclusion.
* Patients will be considered for the study if they have undergone a complete history and physical examination during a previously scheduled consultation/evaluation visit with a gastroenterologist in the Mayo Clinic Florida General GI or Motility clinic.

Exclusion Criteria

* Symptoms are thought to represent an organic disorder (e.g., peptic ulcer disease, hepatitis, pancreatitis, inflammatory bowel disease, type I diabetes, a known malignancy, radiation-induced injury, an active infection, vasculitis, celiac disease), or patients have known uncontrolled GERD, esophagitis, eosinophilic esophagitis, or untreated H. pylori.
* Patients with gastroparesis or cyclic vomiting syndrome.
* Patients with prior surgery to the esophagus, stomach or duodenum.
* Patients taking opioids.
* Patients with motion sickness, vertigo, or a seizure disorder
* IBS symptoms are not predominant.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mayo Clinic

OTHER

Sponsor Role lead

Responsible Party

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David J. Cangemi

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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David Cangemi

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

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Mayo Clinic in Florida

Jacksonville, Florida, United States

Site Status RECRUITING

Countries

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United States

Facility Contacts

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David Cangemi, MD

Role: primary

904-953-2000

Related Links

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Other Identifiers

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23-001973

Identifier Type: -

Identifier Source: org_study_id

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