Sleep Initiation and Maintenance DisordersNCT02709369

HIRREM Developmental Study

A study testing HIRREM in people with Sleep Initiation and Maintenance Disorders and Anxiety, run by Wake Forest University Health Sciences at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 11 years and older
Conditions the study is for: Sleep Initiation and Maintenance Disorders, Anxiety, Post-Traumatic Stress Disorder
What is being tested?: HIRREM
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 300 participants
Where: 1 siteUnited States
Study dates: 23 Aug 2011to 25 Oct 2018
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 11 years and older
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

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.

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

United States1 site

Department of Neurology, Wake Forest School of Medicine
Winston-Salem, North Carolina, 27157

Other trials in United States

About this study

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

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.

Conditions: Sleep Initiation and Maintenance Disorders, Anxiety, Post-Traumatic Stress Disorder, Hot Flashes, Headache, Traumatic Brain Injury
Being tested: HIRREM
Keywords: HIRREM, Neuro-technology, Closed-loop, Acoustic stimulation, Allostatic, heart rate variability, baroreflex sensitivity, traumatic brain injury, sports concussion, PTSD, hot flashes, headache, insomnia
Medical subject headings: Sleep Initiation and Maintenance Disorders, Anxiety Disorders, Stress Disorders, Post-Traumatic, Hot Flashes, Headache, Brain Injuries, Traumatic, Post-Concussion Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

HIRREMDevice
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.

Study groups in NCT02709369
Study group	Role	What they receive
Active HIRREM	Experimental	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. Receives: Device: HIRREM

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: Baseline/Enrollment visit
Heart Rate Variability (SDNN)
Heart rate variability is measured in the time domain as standard deviation of beat-to-beat interval
Measured: Up to 2 weeks after the intervention is completed
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.
Measured: Baseline/Enrollment visit
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.
Measured: Up to two weeks after the intervention is completed
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.
Measured: Baseline/Enrollment visit
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.
Measured: Up to two weeks after the intervention is completed
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.
Measured: Baseline/Enrollment visit
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.
Measured: Up to two weeks after the intervention is completed
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.
Measured: Baseline/Enrollment visit
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.
Measured: Up to 2 weeks after the intervention is completed

Secondary outcomes (21)

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.
Measured: enrollment visit/baseline
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.
Measured: 1-2 weeks after intervention is completed
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.
Measured: 4-8 weeks after completion of the intervention
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.
Measured: enrollment visit/baseline
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.
Measured: 1-2 weeks after the intervention is completed
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.
Measured: 4-8 weeks after completion of the intervention
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.
Measured: enrollment visit/baseline
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.
Measured: 1-2 weeks after the intervention is completed
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.
Measured: 4-8 weeks after completion of the intervention
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.
Measured: enrollment visit/baseline
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.
Measured: 1-2 weeks after the intervention is completed
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.
Measured: 4-8 weeks after completion of the intervention
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.
Measured: enrollment visit/baseline
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.
Measured: 1-2 weeks after the intervention is completed
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.
Measured: 4-8 weeks after completion of the intervention
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.
Measured: enrollment visit/baseline
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.
Measured: 1-2 weeks after the intervention is completed
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.
Measured: 4-8 weeks after completion of the intervention
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.
Measured: enrollment visit/baseline
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.
Measured: 1-2 weeks after the intervention is completed
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.
Measured: 4-8 weeks after completion of the intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

23 Aug 201125 Oct 2018

First posted16 Mar 2016 (estimated)
Study start23 Aug 2011
Primary completion25 Oct 2018
Study completion25 Oct 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (10)Papers the sponsor has linked to this study.
Other trials for Sleep Initiation and Maintenance DisordersStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 300 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02709369
Sponsor's protocol ID: IRB00017651
Status last verified: Nov 2018
First submitted: 4 Mar 2016
Last updated: 24 Dec 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No: Data will be shared in publications and presentations. No plan to formally make individual participant data available for this exploratory study

Publications

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.
PubMed 23532171
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.
PubMed 23170244
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.
PubMed 24599239
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.
PubMed 26347688
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.
PubMed 25136325
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.
PubMed 25668305
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.
PubMed 26085968
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.
PubMed 26645307
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.
PubMed 27747793
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.
PubMed 28420362

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 24 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Functional and Physiological Effects of High-resolution, Relational, Resonance-based, Electroencephalic Mirroring (HIRREM) for Neurological, Cardiovascular and Psychophysiological Disorders
ClinicalTrials.gov ID: NCT02709369
Acronym / sponsor ID: IRB00017651
Conditions: Sleep Initiation and Maintenance Disorders, Anxiety, Post-Traumatic Stress Disorder, Hot Flashes, Headache, Traumatic Brain Injury
Keywords: HIRREM, Neuro-technology, Closed-loop, Acoustic stimulation, Allostatic, heart rate variability, baroreflex sensitivity, traumatic brain injury
Study type: Interventional
Recruitment status: Completed
Enrolment: 300 participants (actual)
Lead sponsor: Wake Forest University Health SciencesUniversity, hospital or other
Study start: 23 Aug 2011 (actual)
Primary completion: 25 Oct 2018 (actual)
Study completion: 25 Oct 2018 (actual)
First posted: 16 Mar 2016 (estimated)
Results: Posted 24 Dec 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Active HIRREM	Experimental	Device: HIRREMThis 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.

Who may qualify

Ages: 11 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (4 listed)

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.

Key exclusion criteria (7 listed)

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).

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
HIRREMHIRREM 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.	Device	Active HIRREM

Primary outcome

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
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
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.
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.
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.
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.
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.
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.
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.
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.

21 secondary outcomes

Center for Epidemiologic Studies Depression Scale (CES-D)
Time frame: enrollment visit/baseline
Center for Epidemiologic Studies Depression Scale (CES-D)
Time frame: 1-2 weeks after intervention is completed
Center for Epidemiologic Studies Depression Scale (CES-D)
Time frame: 4-8 weeks after completion of the intervention
Euro Quality of Life--Five Dimension (EQ-5D)
Time frame: enrollment visit/baseline
Euro Quality of Life--Five Dimension (EQ-5D)
Time frame: 1-2 weeks after the intervention is completed
Euro Quality of Life--Five Dimension (EQ-5D)
Time frame: 4-8 weeks after completion of the intervention
Generalized Anxiety Disorder-7 (GAD-7)
Time frame: enrollment visit/baseline
Generalized Anxiety Disorder-7 (GAD-7)
Time frame: 1-2 weeks after the intervention is completed
Generalized Anxiety Disorder-7 (GAD-7)
Time frame: 4-8 weeks after completion of the intervention
Insomnia Severity Index (ISI)
Time frame: enrollment visit/baseline
Insomnia Severity Index (ISI)
Time frame: 1-2 weeks after the intervention is completed
Insomnia Severity Index (ISI)
Time frame: 4-8 weeks after completion of the intervention
Posttraumatic Stress Disorder Checklist (PCL-C)
Time frame: enrollment visit/baseline
Posttraumatic Stress Disorder Checklist (PCL)
Time frame: 1-2 weeks after the intervention is completed
Posttraumatic Stress Disorder Checklist (PCL)
Time frame: 4-8 weeks after completion of the intervention
Rivermead Post-Concussion Symptoms Questionnaire (RPQ)
Time frame: enrollment visit/baseline
Rivermead Post-Concussion Symptoms Questionnaire (RPQ)
Time frame: 1-2 weeks after the intervention is completed
Rivermead Post-Concussion Symptoms Questionnaire (RPQ)
Time frame: 4-8 weeks after completion of the intervention
Drop Stick Reaction Testing
Time frame: enrollment visit/baseline
Drop Stick Reaction Testing
Time frame: 1-2 weeks after the intervention is completed
Drop Stick Reaction Testing
Time frame: 4-8 weeks after completion of the intervention

Results and safety

Results posted to the registry on 24 Dec 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Active HIRREM	300	273

Primary outcome: Heart Rate Variability Standard Deviation of NN Intervals (SDNN)

Time frame: Baseline/Enrollment visit. Mean (Standard Deviation). Unit: milliseconds

Measure	Active HIRREM n = 227
Value	44.41 (22.94)

Population analysed: BIOPAC device was acquired prior to subject 38. Other entries were excluded due to missing or dropped heartbeats.

Primary outcome: Heart Rate Variability (SDNN)

Time frame: Up to 2 weeks after the intervention is completed. Mean (Standard Deviation). Unit: milliseconds

Measure	Active HIRREM n = 227
Value	54.82 (30.63)

Population analysed: BIOPAC device was acquired prior to subject 38. Other entries were excluded due to missing or dropped heartbeats.

Primary outcome: Baroreflex Sensitivity High Frequency (HF) Alpha

Time frame: Baseline/Enrollment visit. Mean (Standard Deviation). Unit: ms^2

Measure	Active HIRREM n = 227
Value	18.81 (14.45)

Population analysed: BIOPAC device was acquired prior to subject 38. Other entries were excluded due to missing or dropped heartbeats.

Primary outcome: Baroreflex Sensitivity High Frequency (HF) Alpha

Time frame: Up to two weeks after the intervention is completed. Mean (Standard Deviation). Unit: ms^2

Measure	Active HIRREM n = 227
Value	26.68 (20.69)

Population analysed: BIOPAC device was acquired prior to subject 38. Other entries were excluded due to missing or dropped heartbeats.

21 secondary outcomes are reported in the full results.

Adverse events

Time frame: Informed consent until 4-8 weeks after completion of the intervention. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Active HIRREM	0 of 300 (0%)	0 of 300 (0%)	0 of 300

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 23532171Gerdes 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.
Background: PubMed 23170244Tegeler 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.
Background: PubMed 24599239Tegeler 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.
Background: PubMed 26347688Gerdes 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 publication: PubMed 25136325Lee 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 publication: PubMed 25668305Tegeler 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 publication: PubMed 26085968Tegeler 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 publication: PubMed 26645307Fortunato 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 publication: PubMed 27747793Tegeler 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.
Derived from this study: PubMed 28420362Tegeler 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.
Individual participant dataSharing planned: No. 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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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Charles H Tegeler, MD principal investigator

Wake Forest University Health Sciences

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing HIRREM in people with Sleep Initiation and Maintenance Disorders and Anxiety, run by Wake Forest University Health Sciences at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 24 Dec 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Heart Rate Variability Standard Deviation of NN Intervals (SDNN) (time frame: Baseline/Enrollment visit). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02709369, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Dec 2019.