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

PTSD Clinical Trial

— Apollo 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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05019651
• Other study ID #: 20-2268
• Status: Completed
• Phase: Phase 2
• Start date: February 1, 2022
• Est. completion date: June 30, 2023

Study information

• Verified date: September 2023
• Source: VA Eastern Colorado Health Care System
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 63
• Est. completion date: June 30, 2023
• Est. primary completion date: June 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• PTSD

Intervention

Device:
• 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.

Locations

Country	Name	City	State
United States	Eastern Colorado Health Care System (ECHCS)	Aurora	Colorado

Sponsors (2)

Lead Sponsor	Collaborator
Lisa Brenner	Apollo Neuroscience

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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