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

Lisa Brenner

Status and phase: Completed; Phase 2

Conditions: PTSD

Treatments: Device: Apollo Wearable System

Study type: Interventional

Funder types: Other U.S. Federal agency; Other

Identifiers

NCT05019651

20-2268

Details and patient eligibility

About

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.

Full 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

Enrollment: 63 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Veterans eligible to receive care by a VA provider
2. History of at least one deployment in support of Operation Enduring Freedom (OEF), Operation Iraqi Freedom (OIF), and Operation New Dawn (OND)
3. Current diagnosis of PTSD per the Clinician Administered PTSD Scale-5 (CAPS-5)
4. Willingness to wear the Apollo daily and to comply with study protocol
5. Android or Apple smart phone on which the participant can download the Apollo mobile app
6. Age between 18 and 65
7. Ability to provide informed consent

Exclusion criteria

1. Inability to adequately respond to questions regarding the informed consent procedure
2. Currently involved in the criminal justice system as a prisoner or ward of the state
3. Current (past month) alcohol or substance abuse or dependence
4. Lifetime history of bipolar disorder, psychosis, or delusional disorders
5. Lifetime history of oppositional defiant disorder or anti-social personality disorder
6. Pregnancy
7. Recent medication changes in the past 4 weeks
8. A current beta blocker prescription (other than prazosin)
9. Active untreated visual impairment

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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63 participants in 1 patient group

Single Arm- Apollo Wearable System

Experimental group

Description:

Apollo Device TVS (10-200 Hz) attached to the subject's wrist or ankle via a commercially available wearable vibration technology can deliver TVS (Transcutaneous Vibratory Stimulation). The intensity will be targeted for the sensory threshold (the level at which the vibration is just noticeable) as this is where the TVS seems to be most effective from prior studies. Similar vibratory stimuli have been demonstrated to be safe in the literature.10-14 The intensity of the vibration will be adjusted to the subjects' comfort and can be controlled by the subject at any time.

Treatment:

Device: Apollo Wearable System