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HIRREM Developmental Study

Primary Purpose

Sleep Initiation and Maintenance Disorders, Anxiety, Post-Traumatic Stress Disorder

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
HIRREM
Sponsored by
Wake Forest University Health Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sleep Initiation and Maintenance Disorders focused on measuring HIRREM, Neuro-technology, Closed-loop, Acoustic stimulation, Allostatic, heart rate variability, baroreflex sensitivity, traumatic brain injury, sports concussion, PTSD, hot flashes, headache, insomnia

Eligibility Criteria

11 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Male and female adults and children aged 11 years and older.
  • Subjects who are over the age of 18 must be able to give informed consent. Children must be able to sign an assent form and have a signed parental permission form.
  • Subjects must have the ability to comply with basic instructions and be able to sit still comfortably with the sensor leads attached.
  • Subjects previously diagnosed with a neurologic, cardiovascular, or psychophysiological disease such as attention deficit hyperactivity disorder, Asperger Syndrome, chronic pain, dyslexia, depression, insomnia, migraines, anxiety, PTSD, substance abuse disorder, traumatic brain injury, and others.

Exclusion Criteria:

  • Subjects who fail to meet inclusion criteria.
  • Subjects who are unable, unwilling, or incompetent to provide informed consent, assent and/or parental permission.
  • Subjects physically unable to come to the study visits.
  • Subjects with a known seizure disorder.
  • Subjects with severe bilateral hearing impairment (HIRREM requires the use of headphones).
  • Subjects receiving ongoing treatment with opiate, benzodiazepine, anti-psychotic or sleep medications, as well as some anti-depressants or stimulants, except those cases deemed acceptable by the principal investigator.
  • Subjects with anticipated and ongoing use of recreational drugs except when deemed acceptable by the principal investigator.

Sites / Locations

  • Department of Neurology, Wake Forest School of Medicine

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Active HIRREM

Arm Description

This is a single site, single-arm, open-label, developmental study. Participants are recruited to receive eight to twenty sessions of High-resolution, relational, resonance-based electroencephalic mirroring (HIRREM), in addition to their usual care.

Outcomes

Primary Outcome Measures

Heart Rate Variability Standard Deviation of NN Intervals (SDNN)
Heart rate variability is measured in the time domain as standard deviation of beat-to-beat interval
Heart Rate Variability (SDNN)
Heart rate variability is measured in the time domain as standard deviation of beat-to-beat interval
Baroreflex Sensitivity High Frequency (HF) Alpha
Analysis is conducted on the first complete 5-minute epoch that is considered to be acceptable for analysis using Nevrokard Baroreflex Sensitivity (BRS) software.
Baroreflex Sensitivity High Frequency (HF) Alpha
Analysis is conducted on the first complete 5-minute epoch that is considered to be acceptable for analysis using Nevrokard Baroreflex Sensitivity (BRS) software.
Baroreflex Sensitivity Sequence Up
Analysis is conducted on the first complete 5-minute epoch that is considered to be acceptable for analysis using Nevrokard Baroreflex Sensitivity (BRS) software.
Baroreflex Sensitivity Sequence Up
Analysis is conducted on the first complete 5-minute epoch that is considered to be acceptable for analysis using Nevrokard Baroreflex Sensitivity (BRS) software.
Baroreflex Sensitivity Sequence Down
Analysis is conducted on the first complete 5-minute epoch that is considered to be acceptable for analysis using Nevrokard Baroreflex Sensitivity (BRS) software.
Baroreflex Sensitivity Sequence Down
Analysis is conducted on the first complete 5-minute epoch that is considered to be acceptable for analysis using Nevrokard Baroreflex Sensitivity (BRS) software.
Baroreflex Sensitivity Sequence All
Analysis is conducted on the first complete 5-minute epoch that is considered to be acceptable for analysis using Nevrokard Baroreflex Sensitivity (BRS) software.
Baroreflex Sensitivity Sequence All
Analysis is conducted on the first complete 5-minute epoch that is considered to be acceptable for analysis using Nevrokard Baroreflex Sensitivity (BRS) software.

Secondary Outcome Measures

Center for Epidemiologic Studies Depression Scale (CES-D)
The CES-D is a 20-item survey assessing affective depressive symptomatology to screen for risk of depression. Scores range from 0-60, with a score of 16 commonly used as a clinically relevant cut-off. Higher scores suggest the presence of more symptomatology.
Center for Epidemiologic Studies Depression Scale (CES-D)
The CES-D is a 20-item survey assessing affective depressive symptomatology to screen for risk of depression. Scores range from 0-60, with a score of 16 commonly used as a clinically relevant cut-off. Higher scores suggest the presence of more symptomatology.
Center for Epidemiologic Studies Depression Scale (CES-D)
The CES-D is a 20-item survey assessing affective depressive symptomatology to screen for risk of depression. Scores range from 0-60, with a score of 16 commonly used as a clinically relevant cut-off. Higher scores suggest the presence of more symptomatology.
Euro Quality of Life--Five Dimension (EQ-5D)
The EQ-5D is a brief, standardized measure of health status developed by the EuroQol Group, and is a paper and pencil survey providing a single index value for health status. The score reported is current health status which ranges from 0 to 100 with a higher score denoting a better outcome.
Euro Quality of Life--Five Dimension (EQ-5D)
The EQ-5D is a brief, standardized measure of health status developed by the EuroQol Group, and is a paper and pencil survey providing a single index value for health status. The score reported is current health status which ranges from 0 to 100 with a higher score denoting a better outcome.
Euro Quality of Life--Five Dimension (EQ-5D)
The EQ-5D is a brief, standardized measure of health status developed by the EuroQol Group, and is a paper and pencil survey providing a single index value for health status. The score reported is current health status which ranges from 0 to 100 with a higher score denoting a better outcome.
Generalized Anxiety Disorder-7 (GAD-7)
The Generalized Anxiety Disorder-7 (GAD-7) is a seven item screening tool for anxiety that is widely used in primary care. Scores range from 0 to 21 with higher scores suggesting anxiety.
Generalized Anxiety Disorder-7 (GAD-7)
The Generalized Anxiety Disorder-7 (GAD-7) is a seven item screening tool for anxiety that is widely used in primary care. Scores range from 0 to 21 with higher scores suggesting anxiety.
Generalized Anxiety Disorder-7 (GAD-7)
The Generalized Anxiety Disorder-7 (GAD-7) is a seven item screening tool for anxiety that is widely used in primary care. Scores range from 0 to 21 with higher scores suggesting anxiety.
Insomnia Severity Index (ISI)
The ISI measures the severity of insomnia symptoms. The ISI is a 7 question measure, with responses from 0-4 for each question, yielding scores ranging from 0-28 where lower scores denote a healthier sleep quality.
Insomnia Severity Index (ISI)
The ISI measures the severity of insomnia symptoms. The ISI is a 7 question measure, with responses from 0-4 for each question, yielding scores ranging from 0-28 where lower scores denote a healthier sleep quality.
Insomnia Severity Index (ISI)
The ISI measures the severity of insomnia symptoms. The ISI is a 7 question measure, with responses from 0-4 for each question, yielding scores ranging from 0-28 where lower scores denote a healthier sleep quality.
Posttraumatic Stress Disorder Checklist (PCL-C)
The PCL - Civilian (C) is a symptom checklist to measure stress severity due to a traumatic experience, in civilian settings. Seventeen items are rated on a Likert scale with a composite score range of 17 to 85. A score of 44 or higher correlates with probability of civilian-related PTSD.
Posttraumatic Stress Disorder Checklist (PCL)
The PCL - Civilian (C) is a symptom checklist to measure stress severity due to a traumatic experience, in civilian settings. Seventeen items are rated on a Likert scale with a composite score range of 17 to 85. A score of 44 or higher correlates with probability of civilian-related PTSD.
Posttraumatic Stress Disorder Checklist (PCL)
The PCL - Civilian (C) is a symptom checklist to measure stress severity due to a traumatic experience, in civilian settings. Seventeen items are rated on a Likert scale with a composite score range of 17 to 85. A score of 44 or higher correlates with probability of civilian-related PTSD.
Rivermead Post-Concussion Symptoms Questionnaire (RPQ)
The Rivermead Post-Concussion Symptoms Questionnaire (RPQ) is a 16-item survey that assesses the severity of the most common post-concussion symptoms on a scale of 0 to 4, with a total score range from 0 to 64 with 64 denoting the greatest symptom severity.
Rivermead Post-Concussion Symptoms Questionnaire (RPQ)
The Rivermead Post-Concussion Symptoms Questionnaire (RPQ) is a 16-item survey that assesses the severity of the most common post-concussion symptoms on a scale of 0 to 4, with a total score range from 0 to 64 with a higher score denoting the greatest symptom severity.
Rivermead Post-Concussion Symptoms Questionnaire (RPQ)
The Rivermead Post-Concussion Symptoms Questionnaire (RPQ) is a 16-item survey that assesses the severity of the most common post-concussion symptoms on a scale of 0 to 4, with a total score range from 0 to 64 with 64 denoting the greatest symptom severity.
Drop Stick Reaction Testing
Reaction testing is measured by a drop-stick apparatus that has been validated as a way to quantify the impact of athletic concussion on psychomotor performance. Following two practice trials, participants perform eight trials, and a mean distance value is calculated. Better reaction time is denoted by a lower score. The scores range from 0 to 100.
Drop Stick Reaction Testing
Reaction testing is measured by a drop-stick apparatus that has been validated as a way to quantify the impact of athletic concussion on psychomotor performance. Following two practice trials, participants perform eight trials, and a mean distance value is calculated. Better reaction time is denoted by a lower score. The scores range from 0 to 100.
Drop Stick Reaction Testing
Reaction testing is measured by a drop-stick apparatus that has been validated as a way to quantify the impact of athletic concussion on psychomotor performance. Following two practice trials, participants perform eight trials, and a mean distance value is calculated. Better reaction time is denoted by a lower score. The scores range from 0 to 100.

Full Information

First Posted
March 4, 2016
Last Updated
December 11, 2019
Sponsor
Wake Forest University Health Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT02709369
Brief Title
HIRREM Developmental Study
Official Title
Functional and Physiological Effects of High-resolution, Relational, Resonance-based, Electroencephalic Mirroring (HIRREM) for Neurological, Cardiovascular and Psychophysiological Disorders
Study Type
Interventional

2. Study Status

Record Verification Date
November 2018
Overall Recruitment Status
Completed
Study Start Date
August 23, 2011 (Actual)
Primary Completion Date
October 25, 2018 (Actual)
Study Completion Date
October 25, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wake Forest University Health Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to explore the functional and physiological effects associated with the use of High-resolution, relational, resonance-based, electroencephalic mirroring (HIRREM), as supplemental care, for symptoms of neurological, cardiovascular, and neuropsychological disorders. This is a non-randomized, open label, and unblinded before-and-after trial, evaluating the effect of HIRREM on an objective, physiological common denominator (heart rate variability, HRV), across a variety of relevant conditions, as well as changes in clinical symptoms inventories, to generate hypotheses and pilot data for investigation in future proposals.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep Initiation and Maintenance Disorders, Anxiety, Post-Traumatic Stress Disorder, Hot Flashes, Headache, Traumatic Brain Injury, Post Concussion Symptoms
Keywords
HIRREM, Neuro-technology, Closed-loop, Acoustic stimulation, Allostatic, heart rate variability, baroreflex sensitivity, traumatic brain injury, sports concussion, PTSD, hot flashes, headache, insomnia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
300 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Active HIRREM
Arm Type
Experimental
Arm Description
This is a single site, single-arm, open-label, developmental study. Participants are recruited to receive eight to twenty sessions of High-resolution, relational, resonance-based electroencephalic mirroring (HIRREM), in addition to their usual care.
Intervention Type
Device
Intervention Name(s)
HIRREM
Intervention Description
HIRREM is a noninvasive, closed-loop, allostatic, acoustic stimulation neuro-technology to facilitate recipient-unique relaxation, auto-calibration, and self-optimization of cortical neural oscillations by reflecting auditory tones in near real time. After an initial HIRREM assessment, evaluating patterns of brain electrical rhythms, subjects get a series of 90-120 minute HIRREM sessions, including 5 to 9 individualized protocols. A protocol is a combination of sensor montage and specific software design, during which dominant brain frequencies, recorded at high spectral resolutions, are translated to audible tones, and reflected back via earphones with as little as 8 milliseconds delay. Protocols are received sitting or reclining in a chair, some with eyes open, others eyes closed.
Primary Outcome Measure Information:
Title
Heart Rate Variability Standard Deviation of NN Intervals (SDNN)
Description
Heart rate variability is measured in the time domain as standard deviation of beat-to-beat interval
Time Frame
Baseline/Enrollment visit
Title
Heart Rate Variability (SDNN)
Description
Heart rate variability is measured in the time domain as standard deviation of beat-to-beat interval
Time Frame
Up to 2 weeks after the intervention is completed
Title
Baroreflex Sensitivity High Frequency (HF) Alpha
Description
Analysis is conducted on the first complete 5-minute epoch that is considered to be acceptable for analysis using Nevrokard Baroreflex Sensitivity (BRS) software.
Time Frame
Baseline/Enrollment visit
Title
Baroreflex Sensitivity High Frequency (HF) Alpha
Description
Analysis is conducted on the first complete 5-minute epoch that is considered to be acceptable for analysis using Nevrokard Baroreflex Sensitivity (BRS) software.
Time Frame
Up to two weeks after the intervention is completed
Title
Baroreflex Sensitivity Sequence Up
Description
Analysis is conducted on the first complete 5-minute epoch that is considered to be acceptable for analysis using Nevrokard Baroreflex Sensitivity (BRS) software.
Time Frame
Baseline/Enrollment visit
Title
Baroreflex Sensitivity Sequence Up
Description
Analysis is conducted on the first complete 5-minute epoch that is considered to be acceptable for analysis using Nevrokard Baroreflex Sensitivity (BRS) software.
Time Frame
Up to two weeks after the intervention is completed
Title
Baroreflex Sensitivity Sequence Down
Description
Analysis is conducted on the first complete 5-minute epoch that is considered to be acceptable for analysis using Nevrokard Baroreflex Sensitivity (BRS) software.
Time Frame
Baseline/Enrollment visit
Title
Baroreflex Sensitivity Sequence Down
Description
Analysis is conducted on the first complete 5-minute epoch that is considered to be acceptable for analysis using Nevrokard Baroreflex Sensitivity (BRS) software.
Time Frame
Up to two weeks after the intervention is completed
Title
Baroreflex Sensitivity Sequence All
Description
Analysis is conducted on the first complete 5-minute epoch that is considered to be acceptable for analysis using Nevrokard Baroreflex Sensitivity (BRS) software.
Time Frame
Baseline/Enrollment visit
Title
Baroreflex Sensitivity Sequence All
Description
Analysis is conducted on the first complete 5-minute epoch that is considered to be acceptable for analysis using Nevrokard Baroreflex Sensitivity (BRS) software.
Time Frame
Up to 2 weeks after the intervention is completed
Secondary Outcome Measure Information:
Title
Center for Epidemiologic Studies Depression Scale (CES-D)
Description
The CES-D is a 20-item survey assessing affective depressive symptomatology to screen for risk of depression. Scores range from 0-60, with a score of 16 commonly used as a clinically relevant cut-off. Higher scores suggest the presence of more symptomatology.
Time Frame
enrollment visit/baseline
Title
Center for Epidemiologic Studies Depression Scale (CES-D)
Description
The CES-D is a 20-item survey assessing affective depressive symptomatology to screen for risk of depression. Scores range from 0-60, with a score of 16 commonly used as a clinically relevant cut-off. Higher scores suggest the presence of more symptomatology.
Time Frame
1-2 weeks after intervention is completed
Title
Center for Epidemiologic Studies Depression Scale (CES-D)
Description
The CES-D is a 20-item survey assessing affective depressive symptomatology to screen for risk of depression. Scores range from 0-60, with a score of 16 commonly used as a clinically relevant cut-off. Higher scores suggest the presence of more symptomatology.
Time Frame
4-8 weeks after completion of the intervention
Title
Euro Quality of Life--Five Dimension (EQ-5D)
Description
The EQ-5D is a brief, standardized measure of health status developed by the EuroQol Group, and is a paper and pencil survey providing a single index value for health status. The score reported is current health status which ranges from 0 to 100 with a higher score denoting a better outcome.
Time Frame
enrollment visit/baseline
Title
Euro Quality of Life--Five Dimension (EQ-5D)
Description
The EQ-5D is a brief, standardized measure of health status developed by the EuroQol Group, and is a paper and pencil survey providing a single index value for health status. The score reported is current health status which ranges from 0 to 100 with a higher score denoting a better outcome.
Time Frame
1-2 weeks after the intervention is completed
Title
Euro Quality of Life--Five Dimension (EQ-5D)
Description
The EQ-5D is a brief, standardized measure of health status developed by the EuroQol Group, and is a paper and pencil survey providing a single index value for health status. The score reported is current health status which ranges from 0 to 100 with a higher score denoting a better outcome.
Time Frame
4-8 weeks after completion of the intervention
Title
Generalized Anxiety Disorder-7 (GAD-7)
Description
The Generalized Anxiety Disorder-7 (GAD-7) is a seven item screening tool for anxiety that is widely used in primary care. Scores range from 0 to 21 with higher scores suggesting anxiety.
Time Frame
enrollment visit/baseline
Title
Generalized Anxiety Disorder-7 (GAD-7)
Description
The Generalized Anxiety Disorder-7 (GAD-7) is a seven item screening tool for anxiety that is widely used in primary care. Scores range from 0 to 21 with higher scores suggesting anxiety.
Time Frame
1-2 weeks after the intervention is completed
Title
Generalized Anxiety Disorder-7 (GAD-7)
Description
The Generalized Anxiety Disorder-7 (GAD-7) is a seven item screening tool for anxiety that is widely used in primary care. Scores range from 0 to 21 with higher scores suggesting anxiety.
Time Frame
4-8 weeks after completion of the intervention
Title
Insomnia Severity Index (ISI)
Description
The ISI measures the severity of insomnia symptoms. The ISI is a 7 question measure, with responses from 0-4 for each question, yielding scores ranging from 0-28 where lower scores denote a healthier sleep quality.
Time Frame
enrollment visit/baseline
Title
Insomnia Severity Index (ISI)
Description
The ISI measures the severity of insomnia symptoms. The ISI is a 7 question measure, with responses from 0-4 for each question, yielding scores ranging from 0-28 where lower scores denote a healthier sleep quality.
Time Frame
1-2 weeks after the intervention is completed
Title
Insomnia Severity Index (ISI)
Description
The ISI measures the severity of insomnia symptoms. The ISI is a 7 question measure, with responses from 0-4 for each question, yielding scores ranging from 0-28 where lower scores denote a healthier sleep quality.
Time Frame
4-8 weeks after completion of the intervention
Title
Posttraumatic Stress Disorder Checklist (PCL-C)
Description
The PCL - Civilian (C) is a symptom checklist to measure stress severity due to a traumatic experience, in civilian settings. Seventeen items are rated on a Likert scale with a composite score range of 17 to 85. A score of 44 or higher correlates with probability of civilian-related PTSD.
Time Frame
enrollment visit/baseline
Title
Posttraumatic Stress Disorder Checklist (PCL)
Description
The PCL - Civilian (C) is a symptom checklist to measure stress severity due to a traumatic experience, in civilian settings. Seventeen items are rated on a Likert scale with a composite score range of 17 to 85. A score of 44 or higher correlates with probability of civilian-related PTSD.
Time Frame
1-2 weeks after the intervention is completed
Title
Posttraumatic Stress Disorder Checklist (PCL)
Description
The PCL - Civilian (C) is a symptom checklist to measure stress severity due to a traumatic experience, in civilian settings. Seventeen items are rated on a Likert scale with a composite score range of 17 to 85. A score of 44 or higher correlates with probability of civilian-related PTSD.
Time Frame
4-8 weeks after completion of the intervention
Title
Rivermead Post-Concussion Symptoms Questionnaire (RPQ)
Description
The Rivermead Post-Concussion Symptoms Questionnaire (RPQ) is a 16-item survey that assesses the severity of the most common post-concussion symptoms on a scale of 0 to 4, with a total score range from 0 to 64 with 64 denoting the greatest symptom severity.
Time Frame
enrollment visit/baseline
Title
Rivermead Post-Concussion Symptoms Questionnaire (RPQ)
Description
The Rivermead Post-Concussion Symptoms Questionnaire (RPQ) is a 16-item survey that assesses the severity of the most common post-concussion symptoms on a scale of 0 to 4, with a total score range from 0 to 64 with a higher score denoting the greatest symptom severity.
Time Frame
1-2 weeks after the intervention is completed
Title
Rivermead Post-Concussion Symptoms Questionnaire (RPQ)
Description
The Rivermead Post-Concussion Symptoms Questionnaire (RPQ) is a 16-item survey that assesses the severity of the most common post-concussion symptoms on a scale of 0 to 4, with a total score range from 0 to 64 with 64 denoting the greatest symptom severity.
Time Frame
4-8 weeks after completion of the intervention
Title
Drop Stick Reaction Testing
Description
Reaction testing is measured by a drop-stick apparatus that has been validated as a way to quantify the impact of athletic concussion on psychomotor performance. Following two practice trials, participants perform eight trials, and a mean distance value is calculated. Better reaction time is denoted by a lower score. The scores range from 0 to 100.
Time Frame
enrollment visit/baseline
Title
Drop Stick Reaction Testing
Description
Reaction testing is measured by a drop-stick apparatus that has been validated as a way to quantify the impact of athletic concussion on psychomotor performance. Following two practice trials, participants perform eight trials, and a mean distance value is calculated. Better reaction time is denoted by a lower score. The scores range from 0 to 100.
Time Frame
1-2 weeks after the intervention is completed
Title
Drop Stick Reaction Testing
Description
Reaction testing is measured by a drop-stick apparatus that has been validated as a way to quantify the impact of athletic concussion on psychomotor performance. Following two practice trials, participants perform eight trials, and a mean distance value is calculated. Better reaction time is denoted by a lower score. The scores range from 0 to 100.
Time Frame
4-8 weeks after completion of the intervention
Other Pre-specified Outcome Measures:
Title
Heart Rate Variability Standard Deviation of NN Intervals (SDNN)
Description
Heart rate variability is measured in the time domain as standard deviation of beat-to-beat interval
Time Frame
4-8 weeks after completion of the intervention
Title
Baroreflex Sensitivity High Frequency (HF) Alpha
Description
Analysis is conducted on the first complete 5-minute epoch that is considered to be acceptable for analysis using Nevrokard Baroreflex Sensitivity (BRS) software.
Time Frame
4-8 weeks after completion of the intervention
Title
Baroreflex Sensitivity Sequence Up
Description
Analysis is conducted on the first complete 5-minute epoch that is considered to be acceptable for analysis using Nevrokard Baroreflex Sensitivity (BRS) software.
Time Frame
4-8 weeks after completion of the intervention
Title
Baroreflex Sensitivity Sequence Down
Description
Analysis is conducted on the first complete 5-minute epoch that is considered to be acceptable for analysis using Nevrokard Baroreflex Sensitivity (BRS) software.
Time Frame
4-8 weeks after completion of the intervention
Title
Baroreflex Sensitivity Sequence All
Description
Analysis is conducted on the first complete 5-minute epoch that is considered to be acceptable for analysis using Nevrokard Baroreflex Sensitivity (BRS) software.
Time Frame
4-8 weeks after completion of the intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
11 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male and female adults and children aged 11 years and older. Subjects who are over the age of 18 must be able to give informed consent. Children must be able to sign an assent form and have a signed parental permission form. Subjects must have the ability to comply with basic instructions and be able to sit still comfortably with the sensor leads attached. Subjects previously diagnosed with a neurologic, cardiovascular, or psychophysiological disease such as attention deficit hyperactivity disorder, Asperger Syndrome, chronic pain, dyslexia, depression, insomnia, migraines, anxiety, PTSD, substance abuse disorder, traumatic brain injury, and others. Exclusion Criteria: Subjects who fail to meet inclusion criteria. Subjects who are unable, unwilling, or incompetent to provide informed consent, assent and/or parental permission. Subjects physically unable to come to the study visits. Subjects with a known seizure disorder. Subjects with severe bilateral hearing impairment (HIRREM requires the use of headphones). Subjects receiving ongoing treatment with opiate, benzodiazepine, anti-psychotic or sleep medications, as well as some anti-depressants or stimulants, except those cases deemed acceptable by the principal investigator. Subjects with anticipated and ongoing use of recreational drugs except when deemed acceptable by the principal investigator.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Charles H Tegeler, MD
Organizational Affiliation
Wake Forest University Health Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Neurology, Wake Forest School of Medicine
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Data will be shared in publications and presentations. No plan to formally make individual participant data available for this exploratory study
Citations:
PubMed Identifier
23532171
Citation
Gerdes L, Gerdes P, Lee SW, H Tegeler C. HIRREM: a noninvasive, allostatic methodology for relaxation and auto-calibration of neural oscillations. Brain Behav. 2013 Mar;3(2):193-205. doi: 10.1002/brb3.116. Epub 2013 Jan 14.
Results Reference
background
PubMed Identifier
23170244
Citation
Tegeler CH, Kumar SR, Conklin D, Lee SW, Gerdes L, Turner DP, Tegeler CL, C Fidali B, Houle TT. Open label, randomized, crossover pilot trial of high-resolution, relational, resonance-based, electroencephalic mirroring to relieve insomnia. Brain Behav. 2012 Nov;2(6):814-24. doi: 10.1002/brb3.101. Epub 2012 Oct 28.
Results Reference
background
PubMed Identifier
24599239
Citation
Tegeler CH, Lee SW, Shaltout HA. Significance of right anterior insula activity for mental health intervention. JAMA Psychiatry. 2014 Mar;71(3):336. doi: 10.1001/jamapsychiatry.2013.3507. No abstract available.
Results Reference
background
PubMed Identifier
26347688
Citation
Gerdes L, Tegeler CH, Lee SW. A groundwork for allostatic neuro-education. Front Psychol. 2015 Aug 17;6:1224. doi: 10.3389/fpsyg.2015.01224. eCollection 2015.
Results Reference
background
PubMed Identifier
25136325
Citation
Lee SW, Gerdes L, Tegeler CL, Shaltout HA, Tegeler CH. A bihemispheric autonomic model for traumatic stress effects on health and behavior. Front Psychol. 2014 Aug 1;5:843. doi: 10.3389/fpsyg.2014.00843. eCollection 2014.
Results Reference
result
PubMed Identifier
25668305
Citation
Tegeler CH, Tegeler CL, Cook JF, Lee SW, Pajewski NM. Reduction in menopause-related symptoms associated with use of a noninvasive neurotechnology for autocalibration of neural oscillations. Menopause. 2015 Jun;22(6):650-5. doi: 10.1097/GME.0000000000000422.
Results Reference
result
PubMed Identifier
26085968
Citation
Tegeler CH, Shaltout HA, Tegeler CL, Gerdes L, Lee SW. Rightward dominance in temporal high-frequency electrical asymmetry corresponds to higher resting heart rate and lower baroreflex sensitivity in a heterogeneous population. Brain Behav. 2015 Jun;5(6):e00343. doi: 10.1002/brb3.343. Epub 2015 May 1.
Results Reference
result
PubMed Identifier
26645307
Citation
Fortunato JE, Tegeler CL, Gerdes L, Lee SW, Pajewski NM, Franco ME, Cook JF, Shaltout HA, Tegeler CH. Use of an allostatic neurotechnology by adolescents with postural orthostatic tachycardia syndrome (POTS) is associated with improvements in heart rate variability and changes in temporal lobe electrical activity. Exp Brain Res. 2016 Mar;234(3):791-8. doi: 10.1007/s00221-015-4499-y. Epub 2015 Dec 8.
Results Reference
result
PubMed Identifier
27747793
Citation
Tegeler CH, Tegeler CL, Cook JF, Lee SW, Gerdes L, Shaltout HA, Miles CM, Simpson SL. A Preliminary Study of the Effectiveness of an Allostatic, Closed-Loop, Acoustic Stimulation Neurotechnology in the Treatment of Athletes with Persisting Post-concussion Symptoms. Sports Med Open. 2016 Dec;2(1):39. doi: 10.1186/s40798-016-0063-y. Epub 2016 Sep 14.
Results Reference
result
PubMed Identifier
28420362
Citation
Tegeler CH, Cook JF, Tegeler CL, Hirsch JR, Shaltout HA, Simpson SL, Fidali BC, Gerdes L, Lee SW. Clinical, hemispheric, and autonomic changes associated with use of closed-loop, allostatic neurotechnology by a case series of individuals with self-reported symptoms of post-traumatic stress. BMC Psychiatry. 2017 Apr 19;17(1):141. doi: 10.1186/s12888-017-1299-x.
Results Reference
derived

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HIRREM Developmental Study

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