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

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 156-participant average among 66 other Stress Disorders, Post-Traumatic trials with a reported enrollment target (79% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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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.

Primary Outcome

The PTSD Checklist (PCL) - Military (M) is a symptom checklist to measure stress severity due to a traumatic experience in military settings. The PCL-M measures the American Psychiatric Association's Diagnostic and statistical manual of mental disorders (DSM-IV) of PTSD symptoms based on traumatic life experience. Seventeen items are rated on a Likert scale from 1 (not at all) to 5 (extremely), with a total score ranging from 17 to 85. Higher scores suggest more PTSD symptoms. Primary outcome fo

Conditions Studied

Stress Disorders, Post-Traumatic

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
Wake Forest University Health Sciences

1,140 total trials

What the finished NCT03230890 record still lists

NCT03230890 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 32 participants, a relatively small participant target, below the 156-participant average among 66 other Stress Disorders, Post-Traumatic trials with a reported enrollment target (79% lower).

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 a single indexed study location in 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.

Learn More About Clinical Trials

Similar trials for Stress Disorders, Post-Traumatic

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT03230890's enrollment target sits among peer trials

32 56th of 66 higher than 11 of 66 other Stress Disorders, Post-Traumatic trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Stress Disorders, Post-Traumatic trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Related registry views

Source: ClinicalTrials.gov NCT03230890, the US trial registry maintained by the National Library of Medicine. NCT03230890 (small enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.