NCT05079568

A Study to Evaluate the Safety and Tolerability of Virtual Reality to Treat Gastroparesis

"A Pilot Study to Assess the Safety, Tolerability and Efficacy of Virtual Reality for the Treatment of Gastroparesis"

• Status: Suspended
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Mayo Clinic · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine if virtual reality therapy is safe and tolerable in treating gastroparesis.

Detailed description

After informed consent patients will be randomized to a 4 week treatment program comparing active VR treatment to sham VR treatment. Symptoms will be measured at baseline and at 2 and 4 weeks using validated questionnaires. A short questionnaire will be answered daily to evaluate changes in nausea.

Conditions

• Gastroparesis

Interventions

Type	Name	Description
DEVICE	Oculus Go VR headset	Virtual reality programs consisting of interactive games, meditation and deep breathing exercises, and passive virtual reality experiences designed to facilitate relaxation.
DEVICE	Sham Oculus Go VR headset	Virtual reality program with two-dimensional nature video

Timeline

• Start date: 2021-10-01
• Primary completion: 2026-12-01
• Completion: 2026-12-01
• First posted: 2021-10-15
• Last updated: 2026-03-06

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study