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| Name | Class |
|---|---|
| Apollo Neuroscience | UNKNOWN |
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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Apollo Wearable System | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Eastern Colorado Health Care System (ECHCS) | Aurora | Colorado | 80045 | United States |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Aug 28, 2023 | Nov 13, 2025 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D013313 | Stress Disorders, Post-Traumatic |
| ID | Term |
|---|---|
| D040921 | Stress Disorders, Traumatic |
| D000068099 | Trauma and Stressor Related Disorders |
| D001523 | Mental Disorders |
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Apollo Wearable System
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| 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 |
| 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 |