Clinical trial NCT05019651: Acceptability and Feasibility of Apollo in Veterans With a History of PTSD
Official title: Acceptability and Feasibility of Apollo Wearable System, Tuned Vibroacoustic Stimulation (TVS) in Veterans With a History of Post-traumatic Stress Disorder (PTSD)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: PTSD
Keywords: Stress
Heart Rate Variability
Microbiome
Lead sponsor: VA Eastern Colorado Health Care System
Sponsor class: FED
Collaborators: name: Apollo Neuroscience
First posted: 2021-08-25
Enrollment: 63
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Apollo Wearable System
Primary purpose: OTHER

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

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

Primary outcomes:
measure: Acceptability via Credibility Scale
timeFrame: 6 +/- 2 weeks
measure: Acceptability via Expectancy Scale
timeFrame: 6 +/- 2 weeks
measure: Acceptability via Client Satisfaction Questionnaire (CSQ)
timeFrame: 6 +/- 2 weeks
measure: Acceptability via Narrative Evaluation of Intervention Interview (NEII)
timeFrame: 6 +/- 2 weeks
measure: Feasibility via Credibility Scale
timeFrame: 6 +/- 2 weeks
measure: Feasibility via via Expectancy Scale
timeFrame: 6 +/- 2 weeks
measure: Feasibility via Client Satisfaction Questionnaire (CSQ)
timeFrame: 6 +/- 2 weeks
measure: Feasibility via Narrative Evaluation of Intervention Interview (NEII)
timeFrame: 6 +/- 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Aurora
country: United States
facility: Eastern Colorado Health Care System (ECHCS)
state: Colorado
Study officials:
References: