Anxiety, Headache, Hot Flashes, Post Concussion Symptoms, Post-Traumatic Stress Disorder, Sleep Initiation and Maintenance Disorders, Traumatic Brain Injury
Conditions
Keywords
HIRREM, Neuro-technology, Closed-loop, Acoustic stimulation, Allostatic, heart rate variability, baroreflex sensitivity, traumatic brain injury, sports concussion, PTSD, hot flashes, headache, insomnia
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.
Interventions
DEVICEHIRREM
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.
Sponsors
Wake Forest University Health Sciences
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
11 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Heart Rate Variability (SDNN) | 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 |
| Heart Rate Variability Standard Deviation of NN Intervals (SDNN) | Baseline/Enrollment visit | Heart rate variability is measured in the time domain as standard deviation of beat-to-beat interval |
| Baroreflex Sensitivity Sequence All | 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 | 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 | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rivermead Post-Concussion Symptoms Questionnaire (RPQ) | 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. |
| Drop Stick Reaction Testing | 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. |
| Posttraumatic Stress Disorder Checklist (PCL-C) | 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. |
| Center for Epidemiologic Studies Depression Scale (CES-D) | 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. |
| Euro Quality of Life--Five Dimension (EQ-5D) | 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. |
| Generalized Anxiety Disorder-7 (GAD-7) | 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. |
| Insomnia Severity Index (ISI) | 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. |
| Posttraumatic Stress Disorder Checklist (PCL) | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Heart Rate Variability Standard Deviation of NN Intervals (SDNN) | 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 |
| Baroreflex Sensitivity Sequence All | 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. |
| Baroreflex Sensitivity Sequence Down | 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. |
| Baroreflex Sensitivity Sequence Up | 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. |
| Baroreflex Sensitivity High Frequency (HF) Alpha | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 300 |
| Total | 300 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Did not received intervention | 2 |
| Overall Study | Lost to Follow-up | 15 |
| Overall Study | Withdrawal by Subject | 10 |
Baseline characteristics
| Characteristic | Active HIRREM |
|---|---|
| Age, Categorical <=18 years | 30 Participants |
| Age, Categorical >=65 years | 42 Participants |
| Age, Categorical Between 18 and 65 years | 228 Participants |
| Race/Ethnicity, Customized African American | 15 Participants |
| Race/Ethnicity, Customized Asian | 5 Participants |
| Race/Ethnicity, Customized Hispanic or Latino | 3 Participants |
| Race/Ethnicity, Customized Other | 1 Participants |
| Race/Ethnicity, Customized White | 276 Participants |
| Region of Enrollment United States | 300 participants |
| Sex: Female, Male Female | 166 Participants |
| Sex: Female, Male Male | 134 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 300 |
| other Total, other adverse events | 0 / 300 |
| serious Total, serious adverse events | 0 / 300 |
Outcome results
Primary
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.
Time frame: Up to two weeks after the intervention is completed
Population: BIOPAC device was acquired prior to subject 38. Other entries were excluded due to missing or dropped heartbeats.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Active HIRREM | Baroreflex Sensitivity High Frequency (HF) Alpha | 26.68 ms^2 | Standard Deviation 20.69 |
Primary
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.
Time frame: Baseline/Enrollment visit
Population: BIOPAC device was acquired prior to subject 38. Other entries were excluded due to missing or dropped heartbeats.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Active HIRREM | Baroreflex Sensitivity High Frequency (HF) Alpha | 18.81 ms^2 | Standard Deviation 14.45 |
Primary
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.
Time frame: Baseline/Enrollment visit
Population: BIOPAC device was acquired prior to subject 38. Other entries were excluded due to missing or dropped heartbeats.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Active HIRREM | Baroreflex Sensitivity Sequence All | 14.63 ms/mmHg | Standard Deviation 11.8 |
Primary
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.
Time frame: Up to 2 weeks after the intervention is completed
Population: BIOPAC device was acquired prior to subject 38. Other entries were excluded due to missing or dropped heartbeats.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Active HIRREM | Baroreflex Sensitivity Sequence All | 20.74 ms/mmHg | Standard Deviation 16.3 |
Primary
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.
Time frame: Baseline/Enrollment visit
Population: BIOPAC device was acquired prior to subject 38. Other entries were excluded due to missing or dropped heartbeats.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Active HIRREM | Baroreflex Sensitivity Sequence Down | 14.15 ms/mmHg | Standard Deviation 11.56 |
Primary
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.
Time frame: Up to two weeks after the intervention is completed
Population: BIOPAC device was acquired prior to subject 38. Other entries were excluded due to missing or dropped heartbeats.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Active HIRREM | Baroreflex Sensitivity Sequence Down | 20.73 ms/mmHg | Standard Deviation 16.76 |
Primary
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.
Time frame: Baseline/Enrollment visit
Population: BIOPAC device was acquired prior to subject 38. Other entries were excluded due to missing or dropped heartbeats.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Active HIRREM | Baroreflex Sensitivity Sequence Up | 15.39 ms/mmHg | Standard Deviation 13.88 |
Primary
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.
Time frame: Up to two weeks after the intervention is completed
Population: BIOPAC device was acquired prior to subject 38. Other entries were excluded due to missing or dropped heartbeats.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Active HIRREM | Baroreflex Sensitivity Sequence Up | 14.15 ms/mmHg | Standard Deviation 11.56 |
Primary
Heart Rate Variability (SDNN)
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
Population: BIOPAC device was acquired prior to subject 38. Other entries were excluded due to missing or dropped heartbeats.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Active HIRREM | Heart Rate Variability (SDNN) | 54.82 milliseconds | Standard Deviation 30.63 |
Primary
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
Time frame: Baseline/Enrollment visit
Population: BIOPAC device was acquired prior to subject 38. Other entries were excluded due to missing or dropped heartbeats.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Active HIRREM | Heart Rate Variability Standard Deviation of NN Intervals (SDNN) | 44.41 milliseconds | Standard Deviation 22.94 |
Secondary
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.
Time frame: enrollment visit/baseline
Population: CES-D was temporarily removed as approved measure of depression (35 subjects). Other entries were excluded if there was incomplete or missing data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Active HIRREM | Center for Epidemiologic Studies Depression Scale (CES-D) | 18.12 score on a scale | Standard Deviation 12.16 |
Secondary
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.
Time frame: 1-2 weeks after intervention is completed
Population: CES-D was temporarily removed as approved measure of depression (35 subjects). Other entries were excluded if there was incomplete or missing data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Active HIRREM | Center for Epidemiologic Studies Depression Scale (CES-D) | 10.00 score on a scale | Standard Deviation 8.96 |
Secondary
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.
Time frame: 4-8 weeks after completion of the intervention
Population: 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 | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Active HIRREM | Center for Epidemiologic Studies Depression Scale (CES-D) | 8.91 score on a scale | Standard Deviation 8.28 |
Secondary
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.
Time frame: 4-8 weeks after completion of the intervention
Population: 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 | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Active HIRREM | Drop Stick Reaction Testing | 22.58 cm | Standard Deviation 5.78 |
Secondary
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.
Time frame: enrollment visit/baseline
Population: 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 | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Active HIRREM | Drop Stick Reaction Testing | 27.20 cm | Standard Deviation 8.25 |
Secondary
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.
Time frame: 1-2 weeks after the intervention is completed
Population: 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 | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Active HIRREM | Drop Stick Reaction Testing | 23.40 cm | Standard Deviation 6.78 |
Secondary
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.
Time frame: enrollment visit/baseline
Population: EQ-5D was added as a study measure at subject 79. Entries were excluded if there was incomplete or missing data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Active HIRREM | Euro Quality of Life--Five Dimension (EQ-5D) | 69.55 score on a scale | Standard Deviation 19.69 |
Secondary
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.
Time frame: 1-2 weeks after the intervention is completed
Population: EQ-5D was added as a study measure at subject 79. Entries were excluded if there was incomplete or missing data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Active HIRREM | Euro Quality of Life--Five Dimension (EQ-5D) | 79.12 score on a scale | Standard Deviation 16.42 |
Secondary
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.
Time frame: 4-8 weeks after completion of the intervention
Population: 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 | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Active HIRREM | Euro Quality of Life--Five Dimension (EQ-5D) | 78.36 score on a scale | Standard Deviation 17.84 |
Secondary
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.
Time frame: 4-8 weeks after completion of the intervention
Population: 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 | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Active HIRREM | Generalized Anxiety Disorder-7 (GAD-7) | 3.66 score on a scale | Standard Deviation 3.49 |
Secondary
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.
Time frame: enrollment visit/baseline
Population: GAD-7 was temporarily removed as approved measure of depression (35 subjects). Other entries were excluded if there was incomplete or missing data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Active HIRREM | Generalized Anxiety Disorder-7 (GAD-7) | 8.31 score on a scale | Standard Deviation 6.01 |
Secondary
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.
Time frame: 1-2 weeks after the intervention is completed
Population: GAD-7 was temporarily removed as approved measure of depression (35 subjects). Other entries were excluded if there was incomplete or missing data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Active HIRREM | Generalized Anxiety Disorder-7 (GAD-7) | 4.35 score on a scale | Standard Deviation 4.19 |
Secondary
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.
Time frame: 4-8 weeks after completion of the intervention
Population: 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 | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Active HIRREM | Insomnia Severity Index (ISI) | 6.22 score on a scale | Standard Deviation 5.43 |
Secondary
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.
Time frame: enrollment visit/baseline
Population: Entries were excluded if there was incomplete or missing data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Active HIRREM | Insomnia Severity Index (ISI) | 13.47 score on a scale | Standard Deviation 7.17 |
Secondary
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.
Time frame: 1-2 weeks after the intervention is completed
Population: Entries were excluded if there was incomplete or missing data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Active HIRREM | Insomnia Severity Index (ISI) | 7.09 score on a scale | Standard Deviation 5.9 |
Secondary
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.
Time frame: 1-2 weeks after the intervention is completed
Population: 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 | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Active HIRREM | Posttraumatic Stress Disorder Checklist (PCL) | 28.50 score on a scale | Standard Deviation 11.37 |
Secondary
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.
Time frame: 4-8 weeks after completion of the intervention
Population: 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 | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Active HIRREM | Posttraumatic Stress Disorder Checklist (PCL) | 26.13 score on a scale | Standard Deviation 9.58 |
Secondary
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.
Time frame: enrollment visit/baseline
Population: 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 | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Active HIRREM | Posttraumatic Stress Disorder Checklist (PCL-C) | 38.75 score on a scale | Standard Deviation 15.43 |
Secondary
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.
Time frame: 4-8 weeks after completion of the intervention
Population: 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 | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Active HIRREM | Rivermead Post-Concussion Symptoms Questionnaire (RPQ) | 16.89 score on a scale | Standard Deviation 14.74 |
Secondary
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.
Time frame: 1-2 weeks after the intervention is completed
Population: 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 | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Active HIRREM | Rivermead Post-Concussion Symptoms Questionnaire (RPQ) | 15.79 score on a scale | Standard Deviation 13.96 |
Secondary
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.
Time frame: enrollment visit/baseline
Population: 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 | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Active HIRREM | Rivermead Post-Concussion Symptoms Questionnaire (RPQ) | 29.60 score on a scale | Standard Deviation 12.82 |
Other Pre-specified
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.
Time frame: 4-8 weeks after completion of the intervention
Other Pre-specified
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.
Time frame: 4-8 weeks after completion of the intervention
Other Pre-specified
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.
Time frame: 4-8 weeks after completion of the intervention
Other Pre-specified
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.
Time frame: 4-8 weeks after completion of the intervention
Other Pre-specified
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
Time frame: 4-8 weeks after completion of the intervention