Apollo Wearable System for Post Traumatic Stress Disorder (PTSD)

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Eastern Colorado Health Care System (ECHCS), Aurora, CO
Post Traumatic Stress Disorder (PTSD)
Apollo Wearable System - Device
Eligibility
18+
All Sexes
Eligible conditions
Select

Study Summary

This study is evaluating whether a meditation program is acceptable to people with traumatic brain injury.

See full description

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Post Traumatic Stress Disorder (PTSD)

Study Objectives

This trial is evaluating whether Apollo Wearable System will improve 8 primary outcomes in patients with Post Traumatic Stress Disorder (PTSD). Measurement will happen over the course of 6 +/- 2 weeks.

6 +/- 2 weeks
Acceptability via Client Satisfaction Questionnaire (CSQ)
Acceptability via Credibility Scale
Acceptability via Expectancy Scale
Acceptability via Narrative Evaluation of Intervention Interview (NEII)
Feasibility via Client Satisfaction Questionnaire (CSQ)
Feasibility via Credibility Scale
Feasibility via Narrative Evaluation of Intervention Interview (NEII)
Feasibility via via Expectancy Scale

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Other trials for Post Traumatic Stress Disorder (PTSD)

Trial Design

1 Treatment Group

Single Arm- Apollo Wearable System
1 of 1
Experimental Treatment

This trial requires 100 total participants across 1 different treatment group

This trial involves a single treatment. Apollo Wearable System is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 2 and have already been tested with other people.

Single Arm- Apollo Wearable System
Device
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.

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 6 +/- 2 weeks
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 6 +/- 2 weeks for reporting.

Closest Location

Eastern Colorado Health Care System (ECHCS) - Aurora, CO

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 7 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
PTSD diagnosis is currently based on the Clinician Administered PTSD Scale-5 (CAPS-5). show original
The Apollo mobile app can be downloaded on an Android or Apple smart phone. show original
Ability to provide informed consent
will have that care coordinated by their VA health care provider show original
The soldier has a history of participating in at least one deployment in support of Operation Enduring Freedom, Operation Iraqi Freedom, and Operation New Dawn. show original
People between the ages of 18 and 65. show original
I am willing to wear the Apollo daily and to comply with the study protocol. show original

Patient Q&A Section

How many people get post traumatic stress disorder (ptsd) a year in the United States?

"In 2004, 1.8 million people in the U.S. had posttraumatic stress disorder (PTSD). The majority (77%) of PTSD cases in the U.S. were seen by a physician, or by some other medical provider. PTSD remains a public health problem and warrants further study to determine the best ways to prevent, reduce, and treat the disorder." - Anonymous Online Contributor

Unverified Answer

What are common treatments for post traumatic stress disorder (ptsd)?

"When PTSD develops secondary to a traumatic event, the number one recommendation has always been to have counselling. The first therapist consulted, however, was often the family or close relationship to make the decision to use CBT." - Anonymous Online Contributor

Unverified Answer

Can post traumatic stress disorder (ptsd) be cured?

"This is an interesting study that uses both qualitative and quantitative measures, and both quantitative and qualitative methods allow for the exploration of the many facets that the experience of trauma. The use of both qualitative and quantitative methods leads to a greater understanding and appreciation for the complex dynamics of the experience of trauma and this in turn, may help to guide the clinician and the client through the challenging processes of change. We are still unsure where to find and who should seek help for a number of complicated issues related to the life trajectory of clients post traumatic stress disorder. The authors aim of this study is, to increase research knowledge, and further clinical skills training of the clinician." - Anonymous Online Contributor

Unverified Answer

What causes post traumatic stress disorder (ptsd)?

"Nearly 85% of patients diagnosed with PTSD develop other psychological problems that are most likely a direct result of the trauma and not caused by the trauma itself. It is important to identify these causes early in the treatment of trauma patients to ensure most patients can be placed back into healthy, socially adaptive functioning and not suffer further emotional and physical stress from chronic relapses. Effective treatment for posttraumatic stress disorder requires that both the patient and the clinician be in a state of mindful awareness in order to prevent overstating or understating the nature of trauma and thus the patient's capacity to heal." - Anonymous Online Contributor

Unverified Answer

What is post traumatic stress disorder (ptsd)?

"PTSDs is a disease that results in the body not being able to regulate emotions that would normally trigger it to handle fear. It often leads survivors to develop suicidal thoughts, commit suicide, act aggressively, act in unpredictable ways and to have difficulty adjusting to normal life. These can lead to significant damage in a person's life. If left untreated, post traumatic stress disorder can cause significant physical and mental health issues such as depression, anxiety, panic disorder, panic attacks, and PTSD. There seems to be a huge increase in incidence of PTSD in recent years across the world." - Anonymous Online Contributor

Unverified Answer

What are the signs of post traumatic stress disorder (ptsd)?

"Symptoms of PTSD typically begin to appear 3 to 5 months after the traumatic event and include symptoms like flashbacks, persistent fear of reminders, problems in social behaviour, and insomnia. Some of these symptoms may linger for the rest of a person's life. A person with PTSD may also be unable to function in their current role due to flashbacks. There are several sub-categories within the disorder and different levels of severity in each case.\n" - Anonymous Online Contributor

Unverified Answer

Is apollo wearable system typically used in combination with any other treatments?

"Apollo is a well-accepted and well-used treatment for PTSD. The combination of Apollo and one other treatment is a highly effective treatment for PTSD; a study of these combinations is a new area for research." - Anonymous Online Contributor

Unverified Answer

Have there been any new discoveries for treating post traumatic stress disorder (ptsd)?

"There have been several discoveries relating to treating PTSD/PTSD and new treatment options are emerging. There is great need for development of new treatment options for treating PTSD/PTSD." - Anonymous Online Contributor

Unverified Answer

How does apollo wearable system work?

"Apollo system is a simple, low-technology wearable, sleep monitor that can be used to identify and classify sleep disorders among US veterans with PTSD. This is a preliminary report only. Please discuss with a scientist before using this paper." - Anonymous Online Contributor

Unverified Answer

How serious can post traumatic stress disorder (ptsd) be?

"PDSM symptoms are common in military veterans, especially those with a history of maltreatment. Although most PDSM symptoms resolve after a brief period of supportive psychotherapy, some PDSM symptom trajectories may persist." - Anonymous Online Contributor

Unverified Answer

Does apollo wearable system improve quality of life for those with post traumatic stress disorder (ptsd)?

"There was a significant improvement in patients who wore the headbands, over the course of 3 months compared with the control group who did not undergo a WST. The improvement was seen in the domains of perceived social functioning and general health, which was a small improvement. In addition, patients who wore the Apollo headbands reported on fewer days of PTSD symptoms. While this does not demonstrate a causal link, the positive results suggest that it is worth looking at in more detail as a potential adjunct to therapy for PTSD." - Anonymous Online Contributor

Unverified Answer

Have there been other clinical trials involving apollo wearable system?

"In a recent study, findings has demonstrated for the first time that it is possible to effectively detect PTSD symptom in a short period of time by using apollo wearable system, although there are some limitations such as the small number of trials." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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