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Behavioural Intervention
Apollo Wearable System for Post-Traumatic Stress Disorder (Apollo PTSD Trial)
Phase 2
Waitlist Available
Research Sponsored by Lisa Brenner
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 +/- 2 weeks
Awards & highlights
Apollo PTSD Trial Summary
This trial will test a new medical device called the Apollo in a group of Veterans. They will also collect data about how the device affects the body.
Apollo PTSD Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 +/- 2 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 +/- 2 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Acceptability via Client Satisfaction Questionnaire (CSQ)
Acceptability via Credibility Scale
Acceptability via Expectancy Scale
+5 moreApollo PTSD Trial Design
1Treatment groups
Experimental Treatment
Group I: Single Arm- Apollo Wearable SystemExperimental Treatment1 Intervention
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Apollo Wearable System
2022
Completed Phase 2
~70
Find a Location
Who is running the clinical trial?
Apollo NeuroscienceUNKNOWN
1 Previous Clinical Trials
25 Total Patients Enrolled
Lisa BrennerLead Sponsor
1 Previous Clinical Trials
44 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You are currently taking a beta blocker medication, except for prazosin.You have a history of bipolar disorder, psychosis, or delusional disorders at any point in your life.You have had a diagnosis of oppositional defiant disorder or anti-social personality disorder at any point in your life.You currently have untreated vision problems that are affecting your ability to see.You have been using drugs or drinking alcohol excessively in the past month.
Research Study Groups:
This trial has the following groups:- Group 1: Single Arm- Apollo Wearable System
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any specific medical criteria that would make a person ineligible for this research?
"This study is seeking around 100 individuals that suffer from PTSD and are aged 18-65."
Answered by AI
Does this research project restrict its participants to those who are under 65 years old?
"The target population for this trial are individuals who are over 18 but have not yet reached 65 years of age."
Answered by AI
Are there any openings for volunteers in this research project?
"Yes. The clinical trial, which was originally posted on February 1st, is currently looking for 100 patients from 1 site, according to the data on clinicaltrials.gov."
Answered by AI
Are there any health concerns associated with the Apollo wearable device?
"The Apollo Wearable System is still being tested for efficacy, but there is already some evidence supporting its safety. Our team gives it a 2."
Answered by AI
Who else is applying?
What state do they live in?
Colorado
North Carolina
How old are they?
18 - 65
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
What site did they apply to?
Eastern Colorado Health Care System (ECHCS)
How many prior treatments have patients received?
3+
Why did patients apply to this trial?
Dealing with mental challenges of PTSD.
PatientReceived 1 prior treatment
How responsive is this trial?
Average response time
- < 2 Days
Typically responds via
Phone Call
Most responsive sites:
- Eastern Colorado Health Care System (ECHCS): < 48 hours
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