Ignite Creation Date:
2025-12-24 @ 11:39 PM
Ignite Modification Date:
2025-12-25 @ 9:30 PM
Study NCT ID:
NCT05019651
Status:
COMPLETED
Last Update Posted:
2025-11-17
First Post:
2021-07-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Acceptability and Feasibility of Apollo in Veterans With a History of PTSD
Sponsor:
Lisa Brenner
Organization:
Study Overview
Official Title:
Acceptability and Feasibility of Apollo Wearable System, Tuned Vibroacoustic Stimulation (TVS) in Veterans With a History of Post-traumatic Stress Disorder (PTSD)
Status:
COMPLETED
Status Verified Date:
2025-11
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:
Apollo PTSD
Brief Summary:
The proposed investigation is an open label pilot study intended to establish the acceptability and feasibility of the Apollo in a population of Veterans. Exploratory data regarding biological signatures will also be collected.
Detailed Description:
Evaluation of Apollo requires a stepwise process in which initial aims are geared towards identifying biological signatures versus diagnosing, treating, mitigating or curing any conditions. Towards the end of identifying potential biological signatures, we hypothesize the following. 1) Participants who use the Apollo will have an attenuated physiological stress response as measured by improved heart rate variability (HRV) compared to baseline. 2) Participants who use Apollo will have attenuated perceived psychological stress measured by lower scores on psychological correlates of acute stress when compared to baseline
Study Oversight
Has Oversight DMC:
False
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?:
None
Is an FDA AA801 Violation?: