NCT05019651

Acceptability and Feasibility of Apollo in Veterans With a History of PTSD

Acceptability and Feasibility of Apollo Wearable System, Tuned Vibroacoustic Stimulation (TVS) in Veterans With a History of Post-traumatic Stress Disorder (PTSD)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 63 (actual)
• Sponsor: Lisa Brenner · Federal
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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

Conditions

• PTSD

Interventions

Type	Name	Description
DEVICE	Apollo Wearable System	Participants will be provided with the Apollo wearable device and asked to install the study mobile application on their mobile phone. Participants will use the Apollo for at least 30 minutes after waking up in the morning and at least 30 minutes before bed on the corresponding settings for those times of day. They will be given the Apollo Device TVS (10-200 Hz) to borrow which they will be instructed to wear for 6 +/- 2 weeks. They will be asked to continue to wear the device until all study data is collected.

Timeline

• Start date: 2022-02-01
• Primary completion: 2023-06-30
• Completion: 2023-06-30
• First posted: 2021-08-25
• Last updated: 2025-11-17

Locations

1 site across 1 country: United States