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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

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Sleep Initiation and Maintenance Disorders
Anxiety
Post-Traumatic Stress Disorder
Hot Flashes
Headache
Traumatic Brain Injury
Post Concussion Symptoms
Intervention Device: HIRREM
Enrollment 300
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Active HIRREM
Hide Arm/Group 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.
Period Title: Overall Study
Started 300
Completed 273
Not Completed 27
Reason Not Completed
Lost to Follow-up             15
Withdrawal by Subject             10
Did not received intervention             2
Arm/Group Title Active HIRREM
Hide Arm/Group 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.
Overall Number of Baseline Participants 300
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 300 participants
<=18 years
30
  10.0%
Between 18 and 65 years
228
  76.0%
>=65 years
42
  14.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 300 participants
Female
166
  55.3%
Male
134
  44.7%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 300 participants
African American
15
   5.0%
Asian
5
   1.7%
Hispanic or Latino
3
   1.0%
White
276
  92.0%
Other
1
   0.3%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 300 participants
300
1.Primary Outcome
Title Heart Rate Variability Standard Deviation of NN Intervals (SDNN)
Hide Description Heart rate variability is measured in the time domain as standard deviation of beat-to-beat interval
Time Frame Baseline/Enrollment visit
Hide Outcome Measure Data
Hide Analysis Population Description
BIOPAC device was acquired prior to subject 38. Other entries were excluded due to missing or dropped heartbeats.
Arm/Group Title Active HIRREM
Hide Arm/Group 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.
Overall Number of Participants Analyzed 227
Mean (Standard Deviation)
Unit of Measure: milliseconds
44.41  (22.94)
2.Primary Outcome
Title Heart Rate Variability (SDNN)
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
BIOPAC device was acquired prior to subject 38. Other entries were excluded due to missing or dropped heartbeats.
Arm/Group Title Active HIRREM
Hide Arm/Group 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.
Overall Number of Participants Analyzed 227
Mean (Standard Deviation)
Unit of Measure: milliseconds
54.82  (30.63)
3.Primary Outcome
Title Baroreflex Sensitivity High Frequency (HF) Alpha
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
BIOPAC device was acquired prior to subject 38. Other entries were excluded due to missing or dropped heartbeats.
Arm/Group Title Active HIRREM
Hide Arm/Group 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.
Overall Number of Participants Analyzed 227
Mean (Standard Deviation)
Unit of Measure: ms^2
18.81  (14.45)
4.Primary Outcome
Title Baroreflex Sensitivity High Frequency (HF) Alpha
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
BIOPAC device was acquired prior to subject 38. Other entries were excluded due to missing or dropped heartbeats.
Arm/Group Title Active HIRREM
Hide Arm/Group 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.
Overall Number of Participants Analyzed 227
Mean (Standard Deviation)
Unit of Measure: ms^2
26.68  (20.69)
5.Primary Outcome
Title Baroreflex Sensitivity Sequence Up
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
BIOPAC device was acquired prior to subject 38. Other entries were excluded due to missing or dropped heartbeats.
Arm/Group Title Active HIRREM
Hide Arm/Group 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.
Overall Number of Participants Analyzed 226
Mean (Standard Deviation)
Unit of Measure: ms/mmHg
15.39  (13.88)
6.Primary Outcome
Title Baroreflex Sensitivity Sequence Up
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
BIOPAC device was acquired prior to subject 38. Other entries were excluded due to missing or dropped heartbeats.
Arm/Group Title Active HIRREM
Hide Arm/Group 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.
Overall Number of Participants Analyzed 226
Mean (Standard Deviation)
Unit of Measure: ms/mmHg
14.15  (11.56)
7.Primary Outcome
Title Baroreflex Sensitivity Sequence Down
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
BIOPAC device was acquired prior to subject 38. Other entries were excluded due to missing or dropped heartbeats.
Arm/Group Title Active HIRREM
Hide Arm/Group 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.
Overall Number of Participants Analyzed 227
Mean (Standard Deviation)
Unit of Measure: ms/mmHg
14.15  (11.56)
8.Primary Outcome
Title Baroreflex Sensitivity Sequence Down
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
BIOPAC device was acquired prior to subject 38. Other entries were excluded due to missing or dropped heartbeats.
Arm/Group Title Active HIRREM
Hide Arm/Group 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.
Overall Number of Participants Analyzed 227
Mean (Standard Deviation)
Unit of Measure: ms/mmHg
20.73  (16.76)
9.Primary Outcome
Title Baroreflex Sensitivity Sequence All
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
BIOPAC device was acquired prior to subject 38. Other entries were excluded due to missing or dropped heartbeats.
Arm/Group Title Active HIRREM
Hide Arm/Group 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.
Overall Number of Participants Analyzed 227
Mean (Standard Deviation)
Unit of Measure: ms/mmHg
14.63  (11.80)
10.Primary Outcome
Title Baroreflex Sensitivity Sequence All
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
BIOPAC device was acquired prior to subject 38. Other entries were excluded due to missing or dropped heartbeats.
Arm/Group Title Active HIRREM
Hide Arm/Group 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.
Overall Number of Participants Analyzed 227
Mean (Standard Deviation)
Unit of Measure: ms/mmHg
20.74  (16.30)
11.Secondary Outcome
Title Center for Epidemiologic Studies Depression Scale (CES-D)
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
CES-D was temporarily removed as approved measure of depression (35 subjects). Other entries were excluded if there was incomplete or missing data.
Arm/Group Title Active HIRREM
Hide Arm/Group 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.
Overall Number of Participants Analyzed 233
Mean (Standard Deviation)
Unit of Measure: score on a scale
18.12  (12.16)
12.Secondary Outcome
Title Center for Epidemiologic Studies Depression Scale (CES-D)
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
CES-D was temporarily removed as approved measure of depression (35 subjects). Other entries were excluded if there was incomplete or missing data.
Arm/Group Title Active HIRREM
Hide Arm/Group 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.
Overall Number of Participants Analyzed 233
Mean (Standard Deviation)
Unit of Measure: score on a scale
10.00  (8.96)
13.Secondary Outcome
Title Center for Epidemiologic Studies Depression Scale (CES-D)
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
CES-D was temporarily removed as approved measure of depression (35 subjects). Other entries were excluded if there was incomplete or missing data. Late data collection visit was added at after participant 65. Out of town subjects typically were not able to make it back for late data collections.
Arm/Group Title Active HIRREM
Hide Arm/Group 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.
Overall Number of Participants Analyzed 115
Mean (Standard Deviation)
Unit of Measure: score on a scale
8.91  (8.28)
14.Secondary Outcome
Title Euro Quality of Life--Five Dimension (EQ-5D)
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
EQ-5D was added as a study measure at subject 79. Entries were excluded if there was incomplete or missing data.
Arm/Group Title Active HIRREM
Hide Arm/Group 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.
Overall Number of Participants Analyzed 202
Mean (Standard Deviation)
Unit of Measure: score on a scale
69.55  (19.69)
15.Secondary Outcome
Title Euro Quality of Life--Five Dimension (EQ-5D)
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
EQ-5D was added as a study measure at subject 79. Entries were excluded if there was incomplete or missing data.
Arm/Group Title Active HIRREM
Hide Arm/Group 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.
Overall Number of Participants Analyzed 202
Mean (Standard Deviation)
Unit of Measure: score on a scale
79.12  (16.42)
16.Secondary Outcome
Title Euro Quality of Life--Five Dimension (EQ-5D)
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
EQ-5D was added as a study measure at subject 79. Entries were excluded if there was incomplete or missing data. Late data collection visit was added at after participant 65. Out of town subjects typically were not able to make it back for late data collections.
Arm/Group Title Active HIRREM
Hide Arm/Group 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.
Overall Number of Participants Analyzed 151
Mean (Standard Deviation)
Unit of Measure: score on a scale
78.36  (17.84)
17.Secondary Outcome
Title Generalized Anxiety Disorder-7 (GAD-7)
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
GAD-7 was temporarily removed as approved measure of depression (35 subjects). Other entries were excluded if there was incomplete or missing data.
Arm/Group Title Active HIRREM
Hide Arm/Group 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.
Overall Number of Participants Analyzed 167
Mean (Standard Deviation)
Unit of Measure: score on a scale
8.31  (6.01)
18.Secondary Outcome
Title Generalized Anxiety Disorder-7 (GAD-7)
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
GAD-7 was temporarily removed as approved measure of depression (35 subjects). Other entries were excluded if there was incomplete or missing data.
Arm/Group Title Active HIRREM
Hide Arm/Group 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.
Overall Number of Participants Analyzed 167
Mean (Standard Deviation)
Unit of Measure: score on a scale
4.35  (4.19)
19.Secondary Outcome
Title Generalized Anxiety Disorder-7 (GAD-7)
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
GAD-7 was temporarily removed as approved measure of depression (35 subjects). Other entries were excluded if there was incomplete or missing data. Late data collection visit was added at after participant 65. Out of town subjects typically were not able to make it back for late data collections.
Arm/Group Title Active HIRREM
Hide Arm/Group 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.
Overall Number of Participants Analyzed 133
Mean (Standard Deviation)
Unit of Measure: score on a scale
3.66  (3.49)
20.Secondary Outcome
Title Insomnia Severity Index (ISI)
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Entries were excluded if there was incomplete or missing data.
Arm/Group Title Active HIRREM
Hide Arm/Group 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.
Overall Number of Participants Analyzed 272
Mean (Standard Deviation)
Unit of Measure: score on a scale
13.47  (7.17)
21.Secondary Outcome
Title Insomnia Severity Index (ISI)
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Entries were excluded if there was incomplete or missing data.
Arm/Group Title Active HIRREM
Hide Arm/Group 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.
Overall Number of Participants Analyzed 270
Mean (Standard Deviation)
Unit of Measure: score on a scale
7.09  (5.90)
22.Secondary Outcome
Title Insomnia Severity Index (ISI)
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Entries were excluded if there was incomplete or missing data. Late data collection visit was added at after participant 65. Out of town subjects typically were not able to make it back for late data collections.
Arm/Group Title Active HIRREM
Hide Arm/Group 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.
Overall Number of Participants Analyzed 160
Mean (Standard Deviation)
Unit of Measure: score on a scale
6.22  (5.43)
23.Secondary Outcome
Title Posttraumatic Stress Disorder Checklist (PCL-C)
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Entries were excluded if there was incomplete or missing data. Scale was exploratory and only administered to people who self-reported trauma or PTSD on medical history form.
Arm/Group Title Active HIRREM
Hide Arm/Group 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.
Overall Number of Participants Analyzed 179
Mean (Standard Deviation)
Unit of Measure: score on a scale
38.75  (15.43)
24.Secondary Outcome
Title Posttraumatic Stress Disorder Checklist (PCL)
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Entries were excluded if there was incomplete or missing data. Scale was exploratory and only administered to people who self-reported trauma or PTSD on medical history form.
Arm/Group Title Active HIRREM
Hide Arm/Group 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.
Overall Number of Participants Analyzed 179
Mean (Standard Deviation)
Unit of Measure: score on a scale
28.50  (11.37)
25.Secondary Outcome
Title Posttraumatic Stress Disorder Checklist (PCL)
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Entries were excluded if there was incomplete or missing data. Scale was exploratory and only administered to people who self-reported trauma or PTSD on medical history form. Late data collection visit was added at after participant 65. Out of town subjects typically were not able to make it back for late data collections.
Arm/Group Title Active HIRREM
Hide Arm/Group 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.
Overall Number of Participants Analyzed 91
Mean (Standard Deviation)
Unit of Measure: score on a scale
26.13  (9.58)
26.Secondary Outcome
Title Rivermead Post-Concussion Symptoms Questionnaire (RPQ)
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Entries were excluded if there was incomplete or missing data. Scale was exploratory and only administered to people who self-reported TBI or concussion on medical history form.
Arm/Group Title Active HIRREM
Hide Arm/Group 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.
Overall Number of Participants Analyzed 48
Mean (Standard Deviation)
Unit of Measure: score on a scale
29.60  (12.82)
27.Secondary Outcome
Title Rivermead Post-Concussion Symptoms Questionnaire (RPQ)
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Entries were excluded if there was incomplete or missing data. Scale was exploratory and only administered to people who self-reported TBI or concussion on medical history form.
Arm/Group Title Active HIRREM
Hide Arm/Group 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.
Overall Number of Participants Analyzed 48
Mean (Standard Deviation)
Unit of Measure: score on a scale
15.79  (13.96)
28.Secondary Outcome
Title Rivermead Post-Concussion Symptoms Questionnaire (RPQ)
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Entries were excluded if there was incomplete or missing data. Scale was exploratory and only administered to people who self-reported TBI or concussion on medical history form. Late data collection visit was added at after participant 65. Out of town subjects typically were not able to make it back for late data collections.
Arm/Group Title Active HIRREM
Hide Arm/Group 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.
Overall Number of Participants Analyzed 35
Mean (Standard Deviation)
Unit of Measure: score on a scale
16.89  (14.74)
29.Secondary Outcome
Title Drop Stick Reaction Testing
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Drop stick reaction testing was temporarily removed as approved measure of depression (35 subjects). Other entries were excluded if there was incomplete or missing data.
Arm/Group Title Active HIRREM
Hide Arm/Group 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.
Overall Number of Participants Analyzed 213
Mean (Standard Deviation)
Unit of Measure: cm
27.20  (8.25)
30.Secondary Outcome
Title Drop Stick Reaction Testing
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Drop stick reaction testing was temporarily removed as approved measure of depression (35 subjects). Other entries were excluded if there was incomplete or missing data.
Arm/Group Title Active HIRREM
Hide Arm/Group 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.
Overall Number of Participants Analyzed 213
Mean (Standard Deviation)
Unit of Measure: cm
23.40  (6.78)
31.Secondary Outcome
Title Drop Stick Reaction Testing
Hide 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
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Hide Analysis Population Description
Drop stick reaction testing was temporarily removed as approved measure of depression (35 subjects). Other entries were excluded if there was incomplete or missing data. Late data collection visit was added at after participant 65. Out of town subjects typically were not able to make it back for late data collections.
Arm/Group Title Active HIRREM
Hide Arm/Group 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.
Overall Number of Participants Analyzed 90
Mean (Standard Deviation)
Unit of Measure: cm
22.58  (5.78)
32.Other Pre-specified Outcome
Title Heart Rate Variability Standard Deviation of NN Intervals (SDNN)
Hide 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
Outcome Measure Data Not Reported
33.Other Pre-specified Outcome
Title Baroreflex Sensitivity High Frequency (HF) Alpha
Hide 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
Outcome Measure Data Not Reported
34.Other Pre-specified Outcome
Title Baroreflex Sensitivity Sequence Up
Hide 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
Outcome Measure Data Not Reported
35.Other Pre-specified Outcome
Title Baroreflex Sensitivity Sequence Down
Hide 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
Outcome Measure Data Not Reported
36.Other Pre-specified Outcome
Title Baroreflex Sensitivity Sequence All
Hide 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
Outcome Measure Data Not Reported
Time Frame Informed consent until 4-8 weeks after completion of the intervention
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Active HIRREM
Hide Arm/Group 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.
All-Cause Mortality
Active HIRREM
Affected / at Risk (%)
Total   0/300 (0.00%) 
Hide Serious Adverse Events
Active HIRREM
Affected / at Risk (%)
Total   0/300 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Active HIRREM
Affected / at Risk (%)
Total   0/300 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Charles H. Tegeler
Organization: Wake Forest School of Medicine
Phone: +1 (336) 716-7651
EMail: ctegeler@wakehealth.edu
Publications of Results:
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Responsible Party: Wake Forest University Health Sciences
ClinicalTrials.gov Identifier: NCT02709369    
Other Study ID Numbers: IRB00017651
First Submitted: March 4, 2016
First Posted: March 16, 2016
Results First Submitted: November 8, 2019
Results First Posted: December 24, 2019
Last Update Posted: December 24, 2019