Virtual Reality (VR) Self-Hypnosis Software

Official title

An Open-label Study of Self-hypnosis Software for Virtual Reality for the Treatment of HIV-associated Chronic Pain - a Development and Usability Study

Overview

This single-site study of self-hypnosis software using an off-the-shelf virtual reality (VR) device (OculusGo™) to determine the software's safety, usability, and preliminary efficacy in pain relief for HIV-associated chronic pain patients. This is funded under the i Prism Funding through Mount Sinai Innovations.

Detailed description

The study will be done in two phases - Phase A is the development of the software by the study team and the engineers targeted to be completed by 4/15/2024. Testing will occur with only the study team. No participants will be involved in the testing phase. Phase B is the participant enrollment phase targeted to start 5/20/2024. A request for FDA Exemption of a non-significant risk combination device has been submitted and granted.

Interventions

• Device Virtual Reality headset
  Self-hypnosis software in a Virtual Reality headset. This is the development of software that provides a self-hypnosis experience that can be inserted into any virtual reality device.

Primary outcome measures

• Number of times the software is used [Time frame: twenty one days]
• Number of adverse events related to the device [Time frame: twenty one days]

Secondary outcome measures (2)

• Quality of Life measured using Pain, Enjoyment and General Activity Scale (PEG) [Time frame: at Week 2, 3 and week 4]
• Quality of life measured using Short Form Brief Pain Inventory (SF-BPI) Scale [Time frame: at Week 2, 3 and week 4]

Eligibility criteria

Patient Eligibility

Inclusion criteria

• Adults age ≥18
• Confirmed diagnosis of HIV, currently on a stable antiretroviral regimen ≥ 90 days.
• Documentation of chronic pain associated with HIV for≥90 days
• Stable pain management regimen ≥90 days, or no pain treatments ≥90 days
• Average pain intensity of 3 or greater on the NRS of the mean daily scores reported between Visit 1 and Visit 2
• Access to the internet via smartphone, computer, or tablet 7. Fluent in English
• Capable of giving informed consent and willingness to comply with study procedures.

Exclusion criteria

• A co-occurring medical or psychiatric condition which would make participation in the study or complicate measurement of changes associated with the intervention.
• Concurrent participation in another investigational protocol for pain treatment
• A psychiatric disorder, medical condition, or other life circumstance, which in the opinion of the PI, would contraindicate attendance at sessions, or make it unlikely that the participant could successfully complete the study procedures.
• Current or prior diagnosis of epilepsy, seizure disorder, dementia, migraines, or other neurological conditions contraindicating the use of virtual reality devices.
• A medical condition predisposing prospective participant to nausea or dizziness 6. Lack of stereoscopic vision or severe hearing impairment
• Injury to eyes, face, or neck that impedes using the VR device
• If participant has access to personal VR gear for gaming or other purposes at home, participant fails to agree not to use these personal VR gear during the course of the protocol.
• Currently pregnant or planning to become pregnant during the study period

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Device feasibility

Study locations

United States · 1 center

• Icahn School of Medicine at Mount Sinai — New York

Identifiers

NCT: NCT06398847 · STUDY-23-00989 · GCO#21-1216

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗