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

NCT05019651 | Completed Phase 2

• 1 other identifier: 20-2268
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 1

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.

Conditions

PTSD

Keywords

Stress; Heart Rate Variability; Microbiome

Outcome Measures

Primary Outcomes (8)

• Acceptability via Credibility Scale

  The Credibility Scale is a three-item questionnaire that will be used to assess patients' sense of the Apollo Wearable Device credibility.

  6 +/- 2 weeks

• Acceptability via Expectancy Scale

  The Credibility Scale is a two-item questionnaire that will be used to assess patients' expectations of the Apollo Wearable Device.

  6 +/- 2 weeks

• Acceptability via Client Satisfaction Questionnaire (CSQ)

  Client Satisfaction Questionnaire (CSQ) is an eight-item questionnaire that will be used to assess patients' satisfaction with the intervention. The CSQ has good reliability and validity and has frequently been used to evaluate community mental health care.

  6 +/- 2 weeks

• Acceptability via Narrative Evaluation of Intervention Interview (NEII)

  Narrative Evaluation of Intervention Interview (NEII) is a 16-item semi-structured interview that is designed to help participants evaluate and describe the process and outcome of an intervention.

  6 +/- 2 weeks

• Feasibility via Credibility Scale

  The Credibility Scale is a three-item questionnaire that will be used to assess patients' sense of the Apollo Wearable Device credibility.

  6 +/- 2 weeks

• Feasibility via via Expectancy Scale

  The Credibility Scale is a two-item questionnaire that will be used to assess patients' expectations of the Apollo Wearable Device.

  6 +/- 2 weeks

• Feasibility via Client Satisfaction Questionnaire (CSQ)

  Client Satisfaction Questionnaire (CSQ) is an eight-item questionnaire that will be used to assess patients' satisfaction with the intervention. The CSQ has good reliability and validity and has frequently been used to evaluate community mental health care.

  6 +/- 2 weeks

• Feasibility via Narrative Evaluation of Intervention Interview (NEII)

  Feasibility will be aNarrative Evaluation of Intervention Interview (NEII) is a 16-item semi-structured interview that is designed to help participants evaluate and describe the process and outcome of an intervention. ssessed using the Credibility/Expectancy Scales, Client Satisfaction Questionnaire (CSQ), and the Narrative Evaluation of Intervention Interview (NEII).

  6 +/- 2 weeks

Study Arms (1)

Single Arm- Apollo Wearable System

EXPERIMENTAL

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.

Device: Apollo Wearable System

Interventions

Apollo Wearable System 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.

Single Arm- Apollo Wearable System

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Lisa Brenner: lead
• Apollo Neuroscience: collaborator

Study Sites (1)

Eastern Colorado Health Care System (ECHCS)

Aurora, Colorado, 80045, United States

Location

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: FED
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director, Rocky Mountain Mental Illness Research, Education, and Clinical Center

Model Details: Apollo Wearable System

Study Record Dates

• First Submitted: July 16, 2021
• First Posted: August 25, 2021
• Study Start: February 1, 2022
• Primary Completion: June 30, 2023
• Study Completion: June 30, 2023
• Last Updated: November 17, 2025

Record last verified: 2025-11

Locations

US (1)