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

NCT ID: NCT05019651

Last Updated: 2025-11-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 63 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-02-01
• Study Completion Date: 2023-06-30

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

Conditions

PTSD

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Single Arm- Apollo Wearable System

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.

Group Type: EXPERIMENTAL

Apollo Wearable System

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Apollo Neuroscience

UNKNOWN

Sponsor Role: collaborator

Lisa Brenner

FED

Sponsor Role: lead

Responsible Party

Lisa Brenner

Director, Rocky Mountain Mental Illness Research, Education, and Clinical Center

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Eastern Colorado Health Care System (ECHCS)

Aurora, Colorado, United States

Countries

United States

Provided Documents

Document Type: Informed Consent Form

View Document

Other Identifiers

20-2268

Identifier Type: -

Identifier Source: org_study_id