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HIRREM Developmental Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02709369
Recruitment Status : Completed
First Posted : March 16, 2016
Results First Posted : December 24, 2019
Last Update Posted : December 24, 2019
Sponsor:
Information provided by (Responsible Party):
Wake Forest University Health Sciences

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.

Condition or disease Intervention/treatment Phase
Sleep Initiation and Maintenance Disorders Anxiety Post-Traumatic Stress Disorder Hot Flashes Headache Traumatic Brain Injury Post Concussion Symptoms Device: HIRREM Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 300 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Functional and Physiological Effects of High-resolution, Relational, Resonance-based, Electroencephalic Mirroring (HIRREM) for Neurological, Cardiovascular and Psychophysiological Disorders
Actual Study Start Date : August 23, 2011
Actual Primary Completion Date : October 25, 2018
Actual Study Completion Date : October 25, 2018

Arm Intervention/treatment
Experimental: Active HIRREM
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.
Device: HIRREM
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 Measures :
  1. Heart Rate Variability Standard Deviation of NN Intervals (SDNN) [ Time Frame: Baseline/Enrollment visit ]
    Heart rate variability is measured in the time domain as standard deviation of beat-to-beat interval

  2. Heart Rate Variability (SDNN) [ Time Frame: Up to 2 weeks after the intervention is completed ]
    Heart rate variability is measured in the time domain as standard deviation of beat-to-beat interval

  3. Baroreflex Sensitivity High Frequency (HF) Alpha [ Time Frame: Baseline/Enrollment visit ]
    Analysis is conducted on the first complete 5-minute epoch that is considered to be acceptable for analysis using Nevrokard Baroreflex Sensitivity (BRS) software.

  4. Baroreflex Sensitivity High Frequency (HF) Alpha [ Time Frame: Up to two weeks after the intervention is completed ]
    Analysis is conducted on the first complete 5-minute epoch that is considered to be acceptable for analysis using Nevrokard Baroreflex Sensitivity (BRS) software.

  5. Baroreflex Sensitivity Sequence Up [ Time Frame: Baseline/Enrollment visit ]
    Analysis is conducted on the first complete 5-minute epoch that is considered to be acceptable for analysis using Nevrokard Baroreflex Sensitivity (BRS) software.

  6. Baroreflex Sensitivity Sequence Up [ Time Frame: Up to two weeks after the intervention is completed ]
    Analysis is conducted on the first complete 5-minute epoch that is considered to be acceptable for analysis using Nevrokard Baroreflex Sensitivity (BRS) software.

  7. Baroreflex Sensitivity Sequence Down [ Time Frame: Baseline/Enrollment visit ]
    Analysis is conducted on the first complete 5-minute epoch that is considered to be acceptable for analysis using Nevrokard Baroreflex Sensitivity (BRS) software.

  8. Baroreflex Sensitivity Sequence Down [ Time Frame: Up to two weeks after the intervention is completed ]
    Analysis is conducted on the first complete 5-minute epoch that is considered to be acceptable for analysis using Nevrokard Baroreflex Sensitivity (BRS) software.

  9. Baroreflex Sensitivity Sequence All [ Time Frame: Baseline/Enrollment visit ]
    Analysis is conducted on the first complete 5-minute epoch that is considered to be acceptable for analysis using Nevrokard Baroreflex Sensitivity (BRS) software.

  10. Baroreflex Sensitivity Sequence All [ Time Frame: Up to 2 weeks after the intervention is completed ]
    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 :
  1. Center for Epidemiologic Studies Depression Scale (CES-D) [ Time Frame: enrollment visit/baseline ]
    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.

  2. Center for Epidemiologic Studies Depression Scale (CES-D) [ Time Frame: 1-2 weeks after intervention is completed ]
    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.

  3. Center for Epidemiologic Studies Depression Scale (CES-D) [ Time Frame: 4-8 weeks after completion of the intervention ]
    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.

  4. Euro Quality of Life--Five Dimension (EQ-5D) [ Time Frame: enrollment visit/baseline ]
    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.

  5. Euro Quality of Life--Five Dimension (EQ-5D) [ Time Frame: 1-2 weeks after the intervention is completed ]
    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.

  6. Euro Quality of Life--Five Dimension (EQ-5D) [ Time Frame: 4-8 weeks after completion of the intervention ]
    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.

  7. Generalized Anxiety Disorder-7 (GAD-7) [ Time Frame: enrollment visit/baseline ]
    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.

  8. Generalized Anxiety Disorder-7 (GAD-7) [ Time Frame: 1-2 weeks after the intervention is completed ]
    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.

  9. Generalized Anxiety Disorder-7 (GAD-7) [ Time Frame: 4-8 weeks after completion of the intervention ]
    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.

  10. Insomnia Severity Index (ISI) [ Time Frame: enrollment visit/baseline ]
    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.

  11. Insomnia Severity Index (ISI) [ Time Frame: 1-2 weeks after the intervention is completed ]
    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.

  12. Insomnia Severity Index (ISI) [ Time Frame: 4-8 weeks after completion of the intervention ]
    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.

  13. Posttraumatic Stress Disorder Checklist (PCL-C) [ Time Frame: enrollment visit/baseline ]
    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.

  14. Posttraumatic Stress Disorder Checklist (PCL) [ Time Frame: 1-2 weeks after the intervention is completed ]
    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.

  15. Posttraumatic Stress Disorder Checklist (PCL) [ Time Frame: 4-8 weeks after completion of the intervention ]
    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.

  16. Rivermead Post-Concussion Symptoms Questionnaire (RPQ) [ Time Frame: enrollment visit/baseline ]
    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.

  17. Rivermead Post-Concussion Symptoms Questionnaire (RPQ) [ Time Frame: 1-2 weeks after the intervention is completed ]
    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.

  18. Rivermead Post-Concussion Symptoms Questionnaire (RPQ) [ Time Frame: 4-8 weeks after completion of the intervention ]
    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.

  19. Drop Stick Reaction Testing [ Time Frame: enrollment visit/baseline ]
    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.

  20. Drop Stick Reaction Testing [ Time Frame: 1-2 weeks after the intervention is completed ]
    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.

  21. Drop Stick Reaction Testing [ Time Frame: 4-8 weeks after completion of the intervention ]
    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.


Other Outcome Measures:
  1. Heart Rate Variability Standard Deviation of NN Intervals (SDNN) [ Time Frame: 4-8 weeks after completion of the intervention ]
    Heart rate variability is measured in the time domain as standard deviation of beat-to-beat interval

  2. Baroreflex Sensitivity High Frequency (HF) Alpha [ Time Frame: 4-8 weeks after completion of the intervention ]
    Analysis is conducted on the first complete 5-minute epoch that is considered to be acceptable for analysis using Nevrokard Baroreflex Sensitivity (BRS) software.

  3. Baroreflex Sensitivity Sequence Up [ Time Frame: 4-8 weeks after completion of the intervention ]
    Analysis is conducted on the first complete 5-minute epoch that is considered to be acceptable for analysis using Nevrokard Baroreflex Sensitivity (BRS) software.

  4. Baroreflex Sensitivity Sequence Down [ Time Frame: 4-8 weeks after completion of the intervention ]
    Analysis is conducted on the first complete 5-minute epoch that is considered to be acceptable for analysis using Nevrokard Baroreflex Sensitivity (BRS) software.

  5. Baroreflex Sensitivity Sequence All [ Time Frame: 4-8 weeks after completion of the intervention ]
    Analysis is conducted on the first complete 5-minute epoch that is considered to be acceptable for analysis using Nevrokard Baroreflex Sensitivity (BRS) software.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   11 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02709369


Locations
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United States, North Carolina
Department of Neurology, Wake Forest School of Medicine
Winston-Salem, North Carolina, United States, 27157
Sponsors and Collaborators
Wake Forest University Health Sciences
Investigators
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Principal Investigator: Charles H Tegeler, MD Wake Forest University Health Sciences
  Study Documents (Full-Text)

Documents provided by Wake Forest University Health Sciences:
Publications of Results:

Other Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Wake Forest University Health Sciences
ClinicalTrials.gov Identifier: NCT02709369    
Other Study ID Numbers: IRB00017651
First Posted: March 16, 2016    Key Record Dates
Results First Posted: December 24, 2019
Last Update Posted: December 24, 2019
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Data will be shared in publications and presentations. No plan to formally make individual participant data available for this exploratory study

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Keywords provided by Wake Forest University Health Sciences:
HIRREM
Neuro-technology
Closed-loop
Acoustic stimulation
Allostatic
heart rate variability
baroreflex sensitivity
traumatic brain injury
sports concussion
PTSD
hot flashes
headache
insomnia
Additional relevant MeSH terms:
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Brain Injuries
Brain Injuries, Traumatic
Sleep Initiation and Maintenance Disorders
Post-Concussion Syndrome
Disease
Headache
Hot Flashes
Stress Disorders, Traumatic
Stress Disorders, Post-Traumatic
Pathologic Processes
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries
Trauma and Stressor Related Disorders
Mental Disorders
Pain
Neurologic Manifestations
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Brain Concussion
Head Injuries, Closed
Wounds, Nonpenetrating