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NCT03230890 · ClinicalTrials.gov registry record · NA

HIRREM in Military Personnel

A NA study of Stress Disorders, Post-Traumatic, sponsored by Wake Forest University Health Sciences.

Completed
Registry status
NA
Development phase
32
Enrollment target
1
Study location

NCT03230890 is a NA study of Stress Disorders, Post-Traumatic that has completed, run by Wake Forest University Health Sciences. The registered enrollment target is 32 participants, below the 155-participant average among 64 other Stress Disorders, Post-Traumatic trials with a reported enrollment target (79% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT03230890, a NA study of Stress Disorders, Post-Traumatic, has completed, sponsored by Wake Forest University Health Sciences.

COMPLETED
Registry status
NA
Development phase
32 participants
Enrollment target
1
Study location

Study Summary

The purpose of this study is to evaluate the effects associated with the use of in-office High-resolution, relational, resonance-based, electroencephalic mirroring (HIRREM) for participants with symptoms of military-related traumatic stress. This is a single site, non-randomized, open label pilot study. Outcome measures collected before, and after the intervention evaluate effects on self-reported symptoms, autonomic cardiovascular regulation, functional measures, blood and saliva biomarkers of stress and inflammation, and network connectivity on whole brain, rest MRI testing. Self-reported symptom outcomes will also be collected remotely at 1, 3, and 6 months after completion of intervention. The study will assess feasibility in this cohort, focused on the Special Operations community, will provide estimates of effect size, and durability of symptom changes, while providing important pilot data for future proposals and investigations.

Interventions

  • DEVICE HIRREM

Study Locations (1)

North Carolina

  • Wake Forest School of Medicine - Winston-Salem

Trial Details

FieldValue
Enrollment Target 32 participants
Start Date 2015-02-16
Est. Completion 2021-04-05
Phase NA

Sponsor

Wake Forest University Health Sciences

1,140 total trials

What the Registry Record Tells You About NCT03230890

The ClinicalTrials.gov registry entry for NCT03230890 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 32 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 155-participant average among 64 other Stress Disorders, Post-Traumatic trials with a reported enrollment target (79% lower). The listed sponsor is Wake Forest University Health Sciences, which has 1,140 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Stress Disorders, Post-Traumatic appearing as the primary indexed condition, and to 1 intervention - of which HIRREM is the first listed.

NCT03230890 reports 1 study location spanning 1 distinct geographic area - top geographies include North Carolina.

Frequently Asked Questions

What is clinical trial NCT03230890 about?

NCT03230890 is a clinical study titled "HIRREM in Military Personnel". The purpose of this study is to evaluate the effects associated with the use of in-office High-resolution, relational, resonance-based, electroencephalic mirroring (HIRREM) for participants with symptoms of military-related traumatic stress. This is a single site, non-randomized, open label pilot st...

What is the current status of trial NCT03230890?

This trial is currently completed. It is a NA study. The enrollment target is 32 participants. The study started on 2015-02-16. Estimated completion is 2021-04-05.

What conditions does trial NCT03230890 study?

This clinical trial studies the following conditions: Stress Disorders, Post-Traumatic.

What interventions are being tested in trial NCT03230890?

The interventions under investigation include: HIRREM (DEVICE).

Who is sponsoring clinical trial NCT03230890?

This trial is sponsored by Wake Forest University Health Sciences, which has 1,140 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT03230890 being conducted?

This trial has 1 study location across North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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