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Completed

NCT Number: NCT02709369

HIRREM Developmental Study

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.

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Key information

Conditions

Sleep Initiation and Maintenance Disorders Anxiety Anxiety Disorders Brain Concussion Brain Diseases Brain Injuries Brain Injuries, Traumatic Central Nervous System Diseases Craniocerebral Trauma Dyssomnias Head Injuries, Closed Headache Hot Flashes Mental Disorders Nervous System Diseases Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Post Concussion Symptoms Post-Concussion Syndrome Post-traumatic Stress Disorder Signs and Symptoms Sleep Disorders, Intrinsic Sleep Wake Disorders Stress Disorders, Post-Traumatic Stress Disorders, Traumatic Trauma and Stressor Related Disorders Trauma, Nervous System Traumatic Brain Injury Wounds and Injuries Wounds, Nonpenetrating

Age range

11 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Neurology, Wake Forest School of Medicine

Winston-Salem, North Carolina, 27157, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

HIRREM

Device

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 outcomes

  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 outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Wake Forest University Health Sciences

Other

Registry information

Official study title

Functional and Physiological Effects of High-resolution, Relational, Resonance-based, Electroencephalic Mirroring (HIRREM) for Neurological, Cardiovascular and Psychophysiological Disorders

Important dates

Study start
2011
Primary completion
2018
Study completion
2018
First posted
Mar 16, 2016
Registry last updated
Dec 24, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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