Virtual Reality (VR) Self-Hypnosis Software

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Устройство 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.

Первичные конечные точки

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

Вторичные конечные точки (2)

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

Критерии участия

Patient Eligibility

Критерии включения

• 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.

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Оценка устройства

Центры проведения

США · 1 центр

• Icahn School of Medicine at Mount Sinai — New York

Идентификаторы

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

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗