Cereset Research In Healthcare Workers During COVID-19
Study Details
Study Description
Brief Summary
The purpose of this study is to evaluate the use of Cereset Research to improve the symptoms of stress in healthcare workers in an open label, waitlist controlled pilot clinical trial, during the period of COVID-19.
Condition or Disease | Intervention/Treatment | Phase |
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N/A |
Detailed Description
The primary objective of this study is to evaluate the effect of CR to improve the Perceived Stress Scale (PSS) in healthcare workers with symptoms of stress, compared to waitlist control, at 4-6 weeks post intervention.
Secondary objectives include evaluating the effect of CR on the self-reported measures of sleep and anxiety. Exploratory measure include a variety of symptom inventories (mood, post-traumatic stress, quality of life, social support, and cognitive function), and autonomic cardiovascular regulation (heart rate variability, HRV).
Methods: This will be a single site, open label, randomized, waitlist controlled pilot clinical trial, enrolling adults aged 18 or older, who have self-reported symptoms of stress or anxiety, and meet a threshold score on self-reported inventories. Up to 166 participants will be enrolled in order to have at least 138 to complete the study. Participants will be randomly assigned to either an Early Intervention (EI) group which will receive 4 CR sessions of audible tones echoing current brainwave activity, following enrollment, or a Delayed Intervention (DI) group which will continue current care only, and will serve as a control group. Participants in both groups will continue their other current care throughout the study.
The primary outcome will be interval change in The Perceived Stress Scale (PSS) which assesses the perception of stress. It is a measure of the degree to which situations in one's life are appraised as stressful. Secondary outcomes include insomnia (Insomnia Severity Index, ISI) and anxiety (Generalized Anxiety Disorder-7, GAD-7). Exploratory outcomes to be collected include symptom inventories for depression (Center for Epidemiological Studies- Depression Scale, CES-D), traumatic stress (PTSD Checklist for civilians, PCL-C), overall quality of life (QOLS), social support (ISEL-12), the Multiple Ability Self-Report Questionnaire (MASQ) for cognitive function, Fatigue Severity Scale (FSS) for fatigue, and mental health (Depression, Anxiety, and Stress Scale, DASS -21). Details about COVID-19 status, interaction, workplace engagement, healthcare utilization, and exposure will be collected. Pre- and post-intervention data collection of physiological parameters (Heart rate, HR, and measures of autonomic cardiovascular regulation assessed by heart rate variability) will be assessed as exploratory outcomes.
All measures will be collected at an enrollment visit (V1), and participants will be randomly assigned to the EI or DI groups. For those in the EI group, the intervention will begin 0-7 days thereafter. Sessions will be administered over 10 days. Post-intervention data collections will be obtained at 0-7 days (V2) after completion of the intervention, and 4-6 weeks (V3, primary outcome) after the V2. Following V3, those in the DI group will be offered the opportunity to cross over to receive 4 CR sessions and will continue to be followed for data collections at 0-7 days (V4) after completing their sessions, and 4-6 weeks (V5) after V4. Because V4 and V5 are not required, these visits will be exploratory. Mean contrasts will be used to compare the changes in measures of autonomic cardiovascular regulation from V1 to V3, the primary outcome, as well as for exploratory outcomes. Linear mixed models, which can accommodate within-subject correlations due to repeated assessments over time, will be used to generate point estimates for effect size along with 95% confidence intervals.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Active Comparator: Cereset Research For this single arm, open label, exploratory trial this will be the intervention arm using 4 CR sessions. |
Device: Cereset Research
The upgraded platform for medical research using the HIRREM technology has been rebranded as Cereset Research® (CR). This system uses the same core technology and algorithms to echo brainwaves in real-time using audible tones, as with HIRREM. The CR system also includes 64-bit processing architecture for faster feedback, the use of 4 sensors, and the use of standard protocols (with flexibility regarding the length and sequencing of the standard protocols), all done with eyes closed. Four sensors are applied to the scalp at a time. However, only two sensors are actively echoing feedback. The software automatically switches from one sensor pair to the other when needed. This reduces the number of sensor placement changes needed, resulting in shorter session time and fewer interruptions.
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Other: Continued Current Care Participants will continue their current care. |
Device: Cereset Research
The upgraded platform for medical research using the HIRREM technology has been rebranded as Cereset Research® (CR). This system uses the same core technology and algorithms to echo brainwaves in real-time using audible tones, as with HIRREM. The CR system also includes 64-bit processing architecture for faster feedback, the use of 4 sensors, and the use of standard protocols (with flexibility regarding the length and sequencing of the standard protocols), all done with eyes closed. Four sensors are applied to the scalp at a time. However, only two sensors are actively echoing feedback. The software automatically switches from one sensor pair to the other when needed. This reduces the number of sensor placement changes needed, resulting in shorter session time and fewer interruptions.
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Outcome Measures
Primary Outcome Measures
- Change in Perceived Stress Scale (PSS) [Baseline]
The Perceived Stress Scale (PSS) is a ten-item psychological instrument for measuring the perception of stress. It is a measure of the degree to which situations in one's life are appraised as stressful. Items were designed to tap how unpredictable, uncontrollable, and overloaded respondents find their lives. The scale, with answers rated from 0-4, also includes a number of direct queries about current levels of experienced stress. Higher scores suggest increase perceived stress.
- Change in Perceived Stress Scale (PSS) [Visit 2 (0-7 days after final session)]
The Perceived Stress Scale (PSS) is a ten-item psychological instrument for measuring the perception of stress. It is a measure of the degree to which situations in one's life are appraised as stressful. Items were designed to tap how unpredictable, uncontrollable, and overloaded respondents find their lives. The scale, with answers rated from 0-4, also includes a number of direct queries about current levels of experienced stress. Higher scores suggest increase perceived stress.
- Change in Perceived Stress Scale (PSS) [Visit 3 (4-6 weeks after V2)]
The Perceived Stress Scale (PSS) is a ten-item psychological instrument for measuring the perception of stress. It is a measure of the degree to which situations in one's life are appraised as stressful. Items were designed to tap how unpredictable, uncontrollable, and overloaded respondents find their lives. The scale, with answers rated from 0-4, also includes a number of direct queries about current levels of experienced stress. Higher scores suggest increase perceived stress.
Secondary Outcome Measures
- Change in Insomnia Severity Index (ISI) [Baseline, V2 (0-7 days after final session), and V3 (4-6 weeks after V2)]
The severity of insomnia symptoms is measured using two self-report symptom inventories with each data collection visit. This includes the Insomnia Severity Index (ISI). The ISI is a 7-question measure, with responses from 0-4 for each question, yielding scores ranging from 0-28. The higher the score, the more suggestive of insomnia.
- Change in Generalized Anxiety Disorder-7 (GAD-7) [Baseline, V2 (0-7 days after final session), and V3 (4-6 weeks after V2)]
The Generalized Anxiety Disorder-7 (GAD-7) is a seven-item screening tool for anxiety that is widely used in primary care. GAD-7 is a brief, reliable and valid measure of assessing generalized anxiety disorder. Higher scores suggest increased anxiety.
Other Outcome Measures
- Change in Center for Epidemiologic Studies Depression Scale (CES-D) [Baseline, V2 (0-7 days after final session), and V3 (4-6 weeks after V2)]
The Center for Epidemiologic Studies Depression Scale (CES-D) is a depression scale, which will help to assess this co-morbidity. 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 increased depression.
- Change in Posttraumatic stress disorder (PTSD) Checklist for Civilians (PCL-C) [Baseline, V2 (0-7 days after final session), and V3 (4-6 weeks after V2)]
The PTSD Checklist for civilians (PCL-C), measures the American Psychiatric Association's Diagnostic and statistical manual of mental disorders (DSM-IV) Criteria B, C, & D of PTSD symptoms based on traumatic life experience either in civilian life, or related to military service, respectively. 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.
- Change in Fatigue Severity Scale (FSS) [Baseline, V2 (0-7 days after final session), and V3 (4-6 weeks after V2)]
Fatigue Severity Scale (FSS) is a nine-item instrument to assess how fatigue interferes with daily activities. Items are scored on a 7-point scale ranging from 1=strongly disagree to 7=strongly agree. Total scores range from 9 to 63 and the higher the rating demonstrates greater fatigue severity .
- Change in Quality of Life Scale (QOLS) [Baseline, V2 (0-7 days after final session), and V3 (4-6 weeks after V2)]
The Quality of Life Scale (QOLS) is a 16-item scale that was modified from a 15-item scale used in chronic disease patients. Topics include different components of daily life such as relationships, community engagement, personal fulfillment, and recreation. Each item is scaled from 1 to 7 and a sum score is calculated to represent higher levels of satisfaction in life (range is 16-112).
- Change in Interpersonal Support Evaluation List (ISEL-12) [Baseline, V2 (0-7 days after final session), and V3 (4-6 weeks after V2)]
The Interpersonal Support Evaluation List - Shortened Version (ISEL-12) is a 12-item scale that was modified from a 40-item scale used to assess perceptions of social support. Three dimensions are evaluated: appraisal support, belonging support, and tangible support. Each item is scaled from 1 to 4 for "Definitely True" to "Definitely False." Scores are summed and higher scores correlate with more perceived social support.
- Change in Multiple Ability Self-Report Questionnaire (MASQ) [Baseline, V2 (0-7 days after final session), and V3 (4-6 weeks after V2)]
The Multiple Ability Self-Report Questionnaire (MASQ) is a self-report questionnaire commonly used to assess perceived cognitive dysfunction. The MASQ has 38 items and assesses five cognitive domains, including language, visual/perceptual ability, verbal memory, visual memory, and attention.
- Change in The Depression, Anxiety, and Stress Scale (DASS-21) [Baseline, V2 (0-7 days after final session), and V3 (4-6 weeks after V2)]
The Depression, Anxiety, and Stress Scale (DASS-21) is a self-report scale with 21 items(Le et al., 2019; D. Lee, 2019). These questions are divided into three subscales to depression, anxiety, and stress, respectively. The depression subscale scoring ranges from normal (0-9), mild depression (10-12), moderate depression (13-20), severe depression (21-27, and extremely severe depression (28-42). The anxiety subscale scoring ranges from normal (0-6), mild anxiety (7-9), moderate anxiety (10-14), severe anxiety (15-19), and extremely severe anxiety (20-42). The stress subscale ranges from normal (0-10), mild stress (11-18), moderate stress (19-26), sever stress (27-34), and extremely severe stress (35-42). This scale is routinely used in COVID-19 (Wang et al., 2020) and SARS literature(McAlonan et al., 2007).
- Heart Rate Variability (HRV) [Baseline, V2 (0-7 days after final session), and V3 (4-6 weeks after V2)]
Measures of heart rate variability in frequency domain will be derived and measures integrated over specified frequency ranges (LF: 0.04-0.15 Hz; HF: 0.15-0.4 Hz). Power of RRI spectra in LF, HF range (LFRRI and HFRRI) and total power (TP) will be calculated in normalized units and ratio of LF/HF used as a measure of sympatho-vagal balance.
- Change in Heart Rate (HR) [Baseline, V2 (0-7 days after final session), and V3 (4-6 weeks after V2)]
Continuous heart rate will be recorded while participant is breathing normally in seated position for 10 minutes using Faros 180 heart rate monitor (Bittium Corporation, Oulu, Finland). Beat to beat intervals (RRI) files will be generated at 1000 Hz via the data acquisition software. Files will be analyzed with Nevrokard HRV software (by Nevrokard Kiauta, d.o.o., Izola, Slovenia). Recordings will be visually inspected to ensure data quality (dropped beats or gross motion artifacts are excluded) and first 5 minutes of usable tracings will be analyzed.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Employed Healthcare workers aged 18 years and older.
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Ability to comply with basic instructions and be able to sit still, comfortably during sessions.
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Subjects experiencing symptoms of stress who meet threshold scores the Perceived Stress Index (PSS, ≥ 14).
Exclusion Criteria:
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Unable, unwilling, or incompetent to provide informed consent/assent.
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Physically unable to come to the study visits, or to sit still, comfortably in a chair for up to 1 hour.
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Severe hearing impairment (because the subject will be using ear buds during CR).
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Weight is over the chair limit (400 pounds).
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Currently enrolled in another active intervention research study.
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Prior use of: HIRREM, HIRREM-SOP, Brainwave Optimization (BWO), Cereset, Cereset Home, or a wearable configuration of the same (B2, or B2v2).
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Prior use of: electroconvulsive therapy (ECT), prior use of transcranial magnetic stimulation (TMS), transcranial direct current stimulation (TDCS), alpha stimulation, Eye movement desensitization and reprocessing (EMDR), brain spotting, neurofeedback, biofeedback, or deep brain stimulation (DBS) within one month before enrollment.
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Known seizure disorder.
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Thoughts of suicide within the last 3 months.
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Current, significant symptoms of long-COVID.
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Current medical student.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | Wake Forest Baptist Health | Winston-Salem | North Carolina | United States | 27104 |
Sponsors and Collaborators
- Wake Forest University Health Sciences
- The Susanne Marcus Collins Foundation, Inc
Investigators
- Principal Investigator: Charles H Tegeler, MD, Wake Forest University Health Sciences
Study Documents (Full-Text)
None provided.More Information
Publications
- Avram J, Balteş FR, Miclea M, Miu AC. Frontal EEG activation asymmetry reflects cognitive biases in anxiety: evidence from an emotional face Stroop task. Appl Psychophysiol Biofeedback. 2010 Dec;35(4):285-92. doi: 10.1007/s10484-010-9138-6.
- Bastien CH, Vallières A, Morin CM. Validation of the Insomnia Severity Index as an outcome measure for insomnia research. Sleep Med. 2001 Jul;2(4):297-307.
- Beauchaine TP, Thayer JF. Heart rate variability as a transdiagnostic biomarker of psychopathology. Int J Psychophysiol. 2015 Nov;98(2 Pt 2):338-350. doi: 10.1016/j.ijpsycho.2015.08.004. Epub 2015 Aug 11. Review.
- Beckham JC, Taft CT, Vrana SR, Feldman ME, Barefoot JC, Moore SD, Mozley SL, Butterfield MI, Calhoun PS. Ambulatory monitoring and physical health report in Vietnam veterans with and without chronic posttraumatic stress disorder. J Trauma Stress. 2003 Aug;16(4):329-35.
- Bellesi M, Riedner BA, Garcia-Molina GN, Cirelli C, Tononi G. Enhancement of sleep slow waves: underlying mechanisms and practical consequences. Front Syst Neurosci. 2014 Oct 28;8:208. doi: 10.3389/fnsys.2014.00208. eCollection 2014.
- Blanchard EB, Jones-Alexander J, Buckley TC, Forneris CA. Psychometric properties of the PTSD Checklist (PCL). Behav Res Ther. 1996 Aug;34(8):669-73.
- Bradley KA, Bush KR, Epler AJ, Dobie DJ, Davis TM, Sporleder JL, Maynard C, Burman ML, Kivlahan DR. Two brief alcohol-screening tests From the Alcohol Use Disorders Identification Test (AUDIT): validation in a female Veterans Affairs patient population. Arch Intern Med. 2003 Apr 14;163(7):821-9.
- Bradley KA, DeBenedetti AF, Volk RJ, Williams EC, Frank D, Kivlahan DR. AUDIT-C as a brief screen for alcohol misuse in primary care. Alcohol Clin Exp Res. 2007 Jul;31(7):1208-17. Epub 2007 Apr 19.
- Burckhardt CS, Anderson KL. The Quality of Life Scale (QOLS): reliability, validity, and utilization. Health Qual Life Outcomes. 2003 Oct 23;1:60. Review.
- Burckhardt CS, Woods SL, Schultz AA, Ziebarth DM. Quality of life of adults with chronic illness: a psychometric study. Res Nurs Health. 1989 Dec;12(6):347-54.
- Bush K, Kivlahan DR, McDonell MB, Fihn SD, Bradley KA. The AUDIT alcohol consumption questions (AUDIT-C): an effective brief screening test for problem drinking. Ambulatory Care Quality Improvement Project (ACQUIP). Alcohol Use Disorders Identification Test. Arch Intern Med. 1998 Sep 14;158(16):1789-95.
- Buysse DJ, Reynolds CF 3rd, Monk TH, Berman SR, Kupfer DJ. The Pittsburgh Sleep Quality Index: a new instrument for psychiatric practice and research. Psychiatry Res. 1989 May;28(2):193-213.
- Carnethon MR, Golden SH, Folsom AR, Haskell W, Liao D. Prospective investigation of autonomic nervous system function and the development of type 2 diabetes: the Atherosclerosis Risk In Communities study, 1987-1998. Circulation. 2003 May 6;107(17):2190-5. Epub 2003 Apr 14.
- Chandra P, Sands RL, Gillespie BW, Levin NW, Kotanko P, Kiser M, Finkelstein F, Hinderliter A, Pop-Busui R, Rajagopalan S, Saran R. Predictors of heart rate variability and its prognostic significance in chronic kidney disease. Nephrol Dial Transplant. 2012 Feb;27(2):700-9. doi: 10.1093/ndt/gfr340. Epub 2011 Sep 12.
- Cohen H, Benjamin J, Geva AB, Matar MA, Kaplan Z, Kotler M. Autonomic dysregulation in panic disorder and in post-traumatic stress disorder: application of power spectrum analysis of heart rate variability at rest and in response to recollection of trauma or panic attacks. Psychiatry Res. 2000 Sep 25;96(1):1-13.
- Cohen S, Kamarck T, Mermelstein R. A global measure of perceived stress. J Health Soc Behav. 1983 Dec;24(4):385-96.
- Dekker JM, Schouten EG, Klootwijk P, Pool J, Swenne CA, Kromhout D. Heart rate variability from short electrocardiographic recordings predicts mortality from all causes in middle-aged and elderly men. The Zutphen Study. Am J Epidemiol. 1997 May 15;145(10):899-908.
- Eckner JT, Kutcher JS, Richardson JK. Pilot evaluation of a novel clinical test of reaction time in national collegiate athletic association division I football players. J Athl Train. 2010 Jul-Aug;45(4):327-32. doi: 10.4085/1062-6050-45.4.327.
- 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.
- FW W, BT L, DS H, JA H, TM K. The PTSD Checklist (PCL): Reliability, validity, and diagnostic utility. 9th Annual Meeting of the International Society for Traumatic Stress Studies. San Antonio, TX.
- 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.
- Hale TS, Smalley SL, Dang J, Hanada G, Macion J, McCracken JT, McGough JJ, Loo SK. ADHD familial loading and abnormal EEG alpha asymmetry in children with ADHD. J Psychiatr Res. 2010 Jul;44(9):605-15. doi: 10.1016/j.jpsychires.2009.11.012. Epub 2009 Dec 16.
- Hale TS, Smalley SL, Hanada G, Macion J, McCracken JT, McGough JJ, Loo SK. Atypical alpha asymmetry in adults with ADHD. Neuropsychologia. 2009 Aug;47(10):2082-8. doi: 10.1016/j.neuropsychologia.2009.03.021. Epub 2009 Apr 5.
- Hale TS, Smalley SL, Walshaw PD, Hanada G, Macion J, McCracken JT, McGough JJ, Loo SK. Atypical EEG beta asymmetry in adults with ADHD. Neuropsychologia. 2010 Oct;48(12):3532-9. doi: 10.1016/j.neuropsychologia.2010.08.002. Epub 2010 Aug 10.
- Heart rate variability: standards of measurement, physiological interpretation and clinical use. Task Force of the European Society of Cardiology and the North American Society of Pacing and Electrophysiology. Circulation. 1996 Mar 1;93(5):1043-65.
- Kaplan NM RB. Technique of blood pressure measurement in the diagnosis of hypertension. UpToDate. Barkris GL, Sheridan AM, eds. Waltham, MA; 2010
- Katz-Leurer M, Rotem H, Keren O, Meyer S. Heart rate and heart rate variability at rest and during exercise in boys who suffered a severe traumatic brain injury and typically-developed controls. Brain Inj. 2010 Feb;24(2):110-4. doi: 10.3109/02699050903508234.
- Kemp AH, Griffiths K, Felmingham KL, Shankman SA, Drinkenburg W, Arns M, Clark CR, Bryant RA. Disorder specificity despite comorbidity: resting EEG alpha asymmetry in major depressive disorder and post-traumatic stress disorder. Biol Psychol. 2010 Oct;85(2):350-4. doi: 10.1016/j.biopsycho.2010.08.001. Epub 2010 Aug 11.
- Kleiger RE, Miller JP, Bigger JT Jr, Moss AJ. Decreased heart rate variability and its association with increased mortality after acute myocardial infarction. Am J Cardiol. 1987 Feb 1;59(4):256-62.
- Lazarev VV, Pontes A, Mitrofanov AA, deAzevedo LC. Interhemispheric asymmetry in EEG photic driving coherence in childhood autism. Clin Neurophysiol. 2010 Feb;121(2):145-52. doi: 10.1016/j.clinph.2009.10.010. Epub 2009 Dec 1.
- Lee EA, Bissett JK, Carter MA, Cowan PA, Pyne JM, Speck PM, Theus SA, Tolley EA. Preliminary findings of the relationship of lower heart rate variability with military sexual trauma and presumed posttraumatic stress disorder. J Trauma Stress. 2013 Apr;26(2):249-56. doi: 10.1002/jts.21797.
- Lee PH, Macfarlane DJ, Lam TH, Stewart SM. Validity of the International Physical Activity Questionnaire Short Form (IPAQ-SF): a systematic review. Int J Behav Nutr Phys Act. 2011 Oct 21;8:115. doi: 10.1186/1479-5868-8-115. Review.
- 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.
- Lee SW, Laurienti PJ, Burdette JH, Tegeler CL, Morgan AR, Simpson SL, Gerdes L, Tegeler CH. Functional Brain Network Changes Following Use of an Allostatic, Closed-Loop, Acoustic Stimulation Neurotechnology for Military-Related Traumatic Stress. J Neuroimaging. 2019 Jan;29(1):70-78. doi: 10.1111/jon.12571. Epub 2018 Oct 10.
- Marsac J. [Heart rate variability: a cardiometabolic risk marker with public health implications]. Bull Acad Natl Med. 2013 Jan;197(1):175-86. Review. French.
- Marzano C, Ferrara M, Sforza E, De Gennaro L. Quantitative electroencephalogram (EEG) in insomnia: a new window on pathophysiological mechanisms. Curr Pharm Des. 2008;14(32):3446-55. Review.
- Metzger LJ, Paige SR, Carson MA, Lasko NB, Paulus LA, Pitman RK, Orr SP. PTSD arousal and depression symptoms associated with increased right-sided parietal EEG asymmetry. J Abnorm Psychol. 2004 May;113(2):324-9.
- Minassian A, Geyer MA, Baker DG, Nievergelt CM, O'Connor DT, Risbrough VB; Marine Resiliency Study Team. Heart rate variability characteristics in a large group of active-duty marines and relationship to posttraumatic stress. Psychosom Med. 2014 May;76(4):292-301. doi: 10.1097/PSY.0000000000000056.
- Morin CM, Belleville G, Bélanger L, Ivers H. The Insomnia Severity Index: psychometric indicators to detect insomnia cases and evaluate treatment response. Sleep. 2011 May 1;34(5):601-8.
- Moscovitch DA, Santesso DL, Miskovic V, McCabe RE, Antony MM, Schmidt LA. Frontal EEG asymmetry and symptom response to cognitive behavioral therapy in patients with social anxiety disorder. Biol Psychol. 2011 Jul;87(3):379-85. doi: 10.1016/j.biopsycho.2011.04.009. Epub 2011 May 13.
- Nolan RP, Jong P, Barry-Bianchi SM, Tanaka TH, Floras JS. Effects of drug, biobehavioral and exercise therapies on heart rate variability in coronary artery disease: a systematic review. Eur J Cardiovasc Prev Rehabil. 2008 Aug;15(4):386-96. doi: 10.1097/HJR.0b013e3283030a97. Review.
- Offenbächer M, Sauer S, Kohls N, Waltz M, Schoeps P. Quality of life in patients with fibromyalgia: validation and psychometric properties of the German Quality of Life Scale (QOLS-G). Rheumatol Int. 2012 Oct;32(10):3243-52. Epub 2011 Oct 30.
- Park J, Marvar PJ, Liao P, Kankam ML, Norrholm SD, Downey RM, McCullough SA, Le NA, Rothbaum BO. Baroreflex dysfunction and augmented sympathetic nerve responses during mental stress in veterans with post-traumatic stress disorder. J Physiol. 2017 Jul 15;595(14):4893-4908. doi: 10.1113/JP274269. Epub 2017 Jun 14.
- Pyne JM, Constans JI, Wiederhold MD, Gibson DP, Kimbrell T, Kramer TL, Pitcock JA, Han X, Williams DK, Chartrand D, Gevirtz RN, Spira J, Wiederhold BK, McCraty R, McCune TR. Heart rate variability: Pre-deployment predictor of post-deployment PTSD symptoms. Biol Psychol. 2016 Dec;121(Pt A):91-98. doi: 10.1016/j.biopsycho.2016.10.008. Epub 2016 Oct 20.
- Rabe S, Beauducel A, Zöllner T, Maercker A, Karl A. Regional brain electrical activity in posttraumatic stress disorder after motor vehicle accident. J Abnorm Psychol. 2006 Nov;115(4):687-98.
- Radloff LS. The CES-D Scale: A Self-Report Depression Scale for Research in the General Population. Applied Psychological Measurement. 1977;1:385-401.
- Riemann D, Spiegelhalder K, Feige B, Voderholzer U, Berger M, Perlis M, Nissen C. The hyperarousal model of insomnia: a review of the concept and its evidence. Sleep Med Rev. 2010 Feb;14(1):19-31. doi: 10.1016/j.smrv.2009.04.002. Epub 2009 May 28. Review.
- Roberts HC, Denison HJ, Martin HJ, Patel HP, Syddall H, Cooper C, Sayer AA. A review of the measurement of grip strength in clinical and epidemiological studies: towards a standardised approach. Age Ageing. 2011 Jul;40(4):423-9. doi: 10.1093/ageing/afr051. Epub 2011 May 30. Review.
- Shah AJ, Lampert R, Goldberg J, Veledar E, Bremner JD, Vaccarino V. Posttraumatic stress disorder and impaired autonomic modulation in male twins. Biol Psychiatry. 2013 Jun 1;73(11):1103-10. doi: 10.1016/j.biopsych.2013.01.019. Epub 2013 Feb 21.
- Shaltout HA, Tegeler CL, Lee SW, Tegeler CH. 0363 IN SUBJECTS WITH INSOMNIA, USE OF A CLOSED-LOOP ACOUSTIC STIMULATION NEUROTECHNOLOGY IMPROVES HEART RATE VARIABILITY AND BAROREFLEX SENSITIVITY: RESULTS OF A PLACEBO-CONTROLLED CLINICAL TRIAL. Sleep. 2017;40:A135-A
- Smarr KL, Keefer AL. Measures of depression and depressive symptoms: Beck Depression Inventory-II (BDI-II), Center for Epidemiologic Studies Depression Scale (CES-D), Geriatric Depression Scale (GDS), Hospital Anxiety and Depression Scale (HADS), and Patient Health Questionnaire-9 (PHQ-9). Arthritis Care Res (Hoboken). 2011 Nov;63 Suppl 11:S454-66. doi: 10.1002/acr.20556. Review.
- Spiegelhalder K, Fuchs L, Ladwig J, Kyle SD, Nissen C, Voderholzer U, Feige B, Riemann D. Heart rate and heart rate variability in subjectively reported insomnia. J Sleep Res. 2011 Mar;20(1 Pt 2):137-45. doi: 10.1111/j.1365-2869.2010.00863.x.
- Spironelli C, Penolazzi B, Angrilli A. Dysfunctional hemispheric asymmetry of theta and beta EEG activity during linguistic tasks in developmental dyslexia. Biol Psychol. 2008 Feb;77(2):123-31. Epub 2007 Oct 2.
- Spitzer RL, Kroenke K, Williams JB, Löwe B. A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med. 2006 May 22;166(10):1092-7.
- Sterling P. Allostasis: a model of predictive regulation. Physiol Behav. 2012 Apr 12;106(1):5-15. doi: 10.1016/j.physbeh.2011.06.004. Epub 2011 Jun 12. Review.
- Stroganova TA, Nygren G, Tsetlin MM, Posikera IN, Gillberg C, Elam M, Orekhova EV. Abnormal EEG lateralization in boys with autism. Clin Neurophysiol. 2007 Aug;118(8):1842-54. Epub 2007 Jun 19.
- 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.
- 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.
- 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. Epub 2016 Sep 14.
- 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.
- Tegeler CL, Gerdes L, Shaltout HA, Cook JF, Simpson SL, Lee SW, Tegeler CH. Successful use of closed-loop allostatic neurotechnology for post-traumatic stress symptoms in military personnel: self-reported and autonomic improvements. Mil Med Res. 2017 Dec 22;4(1):38. doi: 10.1186/s40779-017-0147-0.
- Tegeler CL, Howard LJ, Schmidt KD, Cook JF, Kumar S, Simpson SL, Lee SW, Gerdes L, Tegeler CH. 0389 USE OF A CLOSED-LOOP ACOUSTIC STIMULATION NEUROTECHNOLOGY IMPROVES SYMPTOMS OF MODERATE TO SEVERE INSOMNIA: RESULTS OF A PLACEBO-CONTROLLED TRIAL. Sleep. 2017;40:A145-A.
- Thayer JF, Hansen AL, Saus-Rose E, Johnsen BH. Heart rate variability, prefrontal neural function, and cognitive performance: the neurovisceral integration perspective on self-regulation, adaptation, and health. Ann Behav Med. 2009 Apr;37(2):141-53. doi: 10.1007/s12160-009-9101-z. Epub 2009 May 8.
- Thibodeau R, Jorgensen RS, Kim S. Depression, anxiety, and resting frontal EEG asymmetry: a meta-analytic review. J Abnorm Psychol. 2006 Nov;115(4):715-29.
- Tobaldini E, Nobili L, Strada S, Casali KR, Braghiroli A, Montano N. Heart rate variability in normal and pathological sleep. Front Physiol. 2013 Oct 16;4:294. doi: 10.3389/fphys.2013.00294. Review.
- Tsuji H, Larson MG, Venditti FJ Jr, Manders ES, Evans JC, Feldman CL, Levy D. Impact of reduced heart rate variability on risk for cardiac events. The Framingham Heart Study. Circulation. 1996 Dec 1;94(11):2850-5.
- Wolynczyk-Gmaj D, Szelenberger W. Waking EEG in primary insomnia. Acta Neurobiol Exp (Wars). 2011;71(3):387-92.
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