Ignite Creation Date:
2024-05-06 @ 8:28 PM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06398847
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-03
First Post:
2024-03-28
Brief Title:
Virtual Reality VR Self-Hypnosis Software
Sponsor:
Icahn School of Medicine at Mount Sinai
Organization:
Icahn School of Medicine at Mount Sinai
Study Overview
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
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This single-site study of self-hypnosis software using an off-the-shelf virtual reality VR device OculusGo to determine the softwares 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 4152024 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 5202024 A request for FDA Exemption of a non-significant risk combination device has been submitted and granted
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| GCO21-1216 | OTHER_GRANT | i Prism Grant | None |