Functional Dyspepsia Treatment Using Virtual Reality

NCT05836597 | Recruiting FDA Device

• 1 other identifier: 23-001973
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Functional Dyspepsia

Outcome Measures

Primary Outcomes (1)

• Change in abdominal pain scores

  Measured by the Patient Assessment of Gastrointestinal Disorders-Symptom Severity Index (PAGI-SYM) questionnaire individual scores for abdominal pain. Scored 0-5, with higher scores representing more severe symptoms.

  Baseline, 8 weeks

Secondary Outcomes (5)

• Overall PAGI-SYM scores

  Baseline, 8 weeks

• Change in nausea/vomiting

  Baseline, 8 weeks

• Change in bloating

  Baseline, 8 weeks

• Change in post-prandial fullness

  Baseline, 8 weeks

• Change in heartburn

  Baseline, 8 weeks

Study Arms (2)

Experimental

EXPERIMENTAL

Experimental VR

Device: Virtual reality

Sham

SHAM COMPARATOR

Sham VR

Device: Virtual reality

Interventions

Virtual reality DEVICE

Virtual reality

Experimental; Sham

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Symptoms of dyspepsia thought to represent functional dyspepsia, meeting Rome IV criteria
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Florida

Jacksonville, Florida, 32224, United States

RECRUITING

Related Links

• Mayo Clinic Clinical Trials

Study Officials

• David Cangemi

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 20, 2023
• First Posted: May 1, 2023
• Study Start: April 1, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: January 22, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)