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Completed

NCT Number: NCT05019651

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

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.

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Key information

Conditions

PTSD Mental Disorders Stress Disorders, Post-Traumatic Stress Disorders, Traumatic Trauma and Stressor Related Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Eastern Colorado Health Care System (ECHCS)

Aurora, Colorado, 80045, United States

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

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.

Primary outcomes

  1. Acceptability via Credibility Scale

    Time frame: 6 +/- 2 weeks

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

  2. Acceptability via Expectancy Scale

    Time frame: 6 +/- 2 weeks

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

  3. Acceptability via Client Satisfaction Questionnaire (CSQ)

    Time frame: 6 +/- 2 weeks

    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.

  4. Acceptability via Narrative Evaluation of Intervention Interview (NEII)

    Time frame: 6 +/- 2 weeks

    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.

  5. Feasibility via Credibility Scale

    Time frame: 6 +/- 2 weeks

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

  6. Feasibility via via Expectancy Scale

    Time frame: 6 +/- 2 weeks

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

  7. Feasibility via Client Satisfaction Questionnaire (CSQ)

    Time frame: 6 +/- 2 weeks

    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.

  8. Feasibility via Narrative Evaluation of Intervention Interview (NEII)

    Time frame: 6 +/- 2 weeks

    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).

Sponsors and collaborators

Lead sponsor

Lisa Brenner

Fed

Collaborators

  • Apollo Neuroscience

Registry information

Official study title

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

Acronym: Apollo PTSD

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Aug 25, 2021
Registry last updated
Nov 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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