PTSDPhase 2Apollo PTSDNCT05019651
Acceptability and Feasibility of Apollo in Veterans With a History of PTSD
A Phase 2 study testing Apollo Wearable System in people with PTSD, run by Lisa Brenner at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- PTSD
- What is being tested?
- Apollo Wearable System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2022to 30 Jun 2023
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- Recent medication changes in the past 4 weeks
- A current beta blocker prescription (other than prazosin)
- Active untreated visual impairment
Trial locations and contacts
1 site in 1 country.
United States1 site
Eastern Colorado Health Care System (ECHCS)
Aurora, Colorado, 80045
About this study
Official title: Acceptability and Feasibility of Apollo Wearable System, Tuned Vibroacoustic Stimulation (TVS) in Veterans With a History of Post-traumatic Stress Disorder (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.
Read the 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
- Being tested
- Apollo Wearable System
- Keywords
- Stress, Heart Rate Variability, Microbiome
- Medical subject headings
- Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Apollo Wearable SystemDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Apollo Wearable System |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 6 +/- 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2021
- Study start1 Feb 2022
- Primary completion30 Jun 2023
- Study completion30 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PTSDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Apollo Wearable System
- Masking
- None (open label)
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lisa Brenner
- Sponsor type
- US federal agency
- Collaborators
- Apollo Neuroscience
- Responsible party
- Sponsor-investigator, Lisa Brenner, VA Eastern Colorado Health Care System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05019651
- Sponsor's protocol ID
- 20-2268
- Acronym
- Apollo PTSD
- Status last verified
- Nov 2025
- First submitted
- 16 Jul 2021
- Last updated
- 17 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acceptability and Feasibility of Apollo Wearable System, Tuned Vibroacoustic Stimulation (TVS) in Veterans With a History of Post-traumatic Stress Disorder (PTSD)
- ClinicalTrials.gov ID
- NCT05019651
- Acronym / sponsor ID
- Apollo PTSD / 20-2268
- Conditions
- PTSD
- Keywords
- Stress, Heart Rate Variability, Microbiome
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- Lisa BrennerUS federal agency
- Collaborators
- Apollo Neuroscience
- Study start
- 1 Feb 2022 (actual)
- Primary completion
- 30 Jun 2023 (actual)
- Study completion
- 30 Jun 2023 (actual)
- First posted
- 25 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Apollo Wearable System
| Arm | Type | Receives |
|---|---|---|
| Single Arm- Apollo Wearable System | Experimental | Device: Apollo Wearable SystemApollo 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Apollo Wearable SystemParticipants 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. | Device | Single Arm- Apollo Wearable System |
Primary outcome
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.
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.
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.
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.
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.
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.
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.
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Apollo Wearable System in people with PTSD, run by Lisa Brenner at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acceptability via Credibility Scale (time frame: 6 +/- 2 weeks). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Nov 2025.