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Behavioural Intervention

HIRREM for Post-Traumatic Stress Disorder

N/A

Waitlist Available

Led By Charles H Tegeler, MD

Research Sponsored by Wake Forest University Health Sciences

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 sleep diary data will be collected daily via online access from baseline to a month following completion of intervention (up to 42 days)

Awards & highlights

Study Summary

This trial is testing a new treatment for military-related traumatic stress. The treatment is called HIRREM and is a type of brainwave therapy. 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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ sleep diary data will be collected daily via online access from baseline to a month following completion of intervention (up to 42 days)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~sleep diary data will be collected daily via online access from baseline to a month following completion of intervention (up to 42 days)

This trial's timeline: 3 weeks for screening, Varies for treatment, and sleep diary data will be collected daily via online access from baseline to a month following completion of intervention (up to 42 days) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in PCL-M Score From Baseline to 12 Days

Secondary outcome measures

Change in Baroreflex Sensitivity HF Alpha From Baseline to 12 Days

Change in Baroreflex Sensitivity Sequence All From Baseline to 12 Days

Change in Baroreflex Sensitivity Sequence Down From Baseline to 12 Days

+16 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: HIRREMExperimental Treatment1 Intervention

This is the intervention, treatment arm that all participants receive in this open label, single arm trial. The intervention is High-resolution, relational, resonance-based, electroencephalic mirroring (HIRREM).

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

HIRREM

2018

N/A

~460

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Who is running the clinical trial?

Brain State Technologies, LLCIndustry Sponsor

1 Previous Clinical Trials

80 Total Patients Enrolled

Wake Forest University Health SciencesLead Sponsor

1,241 Previous Clinical Trials

1,004,205 Total Patients Enrolled

Charles H Tegeler, MDPrincipal InvestigatorWake Forest University Health Sciences

5 Previous Clinical Trials

556 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any vacancies for potential participants in this clinical investigation?

"Data posted to clinicaltrials.gov indicates that this particular medical trial is not presently accepting patients, though it was initially added on February 16th 2015 and last updated October 26th 2022. Fortunately, there are 338 alternative studies in search of participants at the moment."

Answered by AI