Clinical trial NCT03777267: Cereset Research Exploratory Study
Official title: Cereset Research Exploratory Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Neurological Diseases or Conditions
Cardiovascular Conditions After Birth
Psychophysiologic Disorders
Keywords: Stress
Neurotechnology
Autonomic Dysregulation
Hyperarousal
Brain electrical activity
Allostasis
HIRREM
Cereset Research
Insomnia
Anxiety
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
Collaborators: name: The Susanne Marcus Collins Foundation, Inc.
First posted: 2018-12-17
Enrollment: 150
Sex: ALL
Minimum age (years): 11
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: This will be a single site, open label, pilot clinical trial, enrolling people aged 11 or older, who have self-reported symptoms of stress, anxiety, or insomnia, and meet a threshold score on self-reported inventories. Up to 100 participants will be enrolled so as to gather pilot data that will help inform regarding effect size, and dosing to support future cohort-specific randomized trials. Participants will receive between 6 and 12 intervention sessions of Cereset Research consisting of audible tones echoing current brainwave activity.
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to evaluate the use of Cereset Research to improve autonomic function in participants with symptoms of stress, anxiety, or insomnia.

Detailed description: The primary objective of this open label exploratory study is to evaluate the effect of CR to improve autonomic cardiovascular regulation in participants with symptoms of stress, anxiety, or insomnia.

The secondary objective is to evaluate the effect of CR on a variety of self-reported symptom inventories.

Tertiary objectives are to explore the impact of selected medications on outcomes associated with use of CR, the effect size in subgroups of participants who also report specific co-morbid symptoms or conditions of interest, and any unexpected challenges or barriers for working with the same. The latter includes those with TBI, PTSD, hypertension, hot flashes, chronic pain, or prior stroke.

Methods: This will be a single site, open label, pilot clinical trial, enrolling people aged 11 or older, who have self-reported symptoms of stress, anxiety, or insomnia, and meet a threshold score on self-reported inventories. Up to 150 participants will be enrolled. Participants will receive between 6 and 12 sessions of audible tones echoing current brainwave activity (CR). Participants will continue their other current care throughout the study. There will be pre- and post-intervention data collection of physiological outcomes (BP, HR, and measures of autonomic cardiovascular regulation assessed by heart rate variability and baroreflex sensitivity), which will alse serve as the primary outcome. Secondary outcomes to be collected include symptom inventories for insomnia (Insomnia Severity Index, ISI; Pittsburgh Sleep Quality Index, PSQI), depression (Center for Epidemiological Studies- Depression Scale, CES-D), anxiety (Generalized Anxiety Disorder-7, GAD-7), stress (Perceived Stress Scale, PSS), traumatic stress (PTSD Checklist for civilians, PCL-C, or military, PCL-M), , and overall quality of life (QOLS). Other secondary outcome inventories will be collected for physical activity (International Physical Activity Questionnaire, IPAQ-SF), and physical activity satisfaction questions, as well. Participants who also self-report having specific co-morbid symptoms or conditions of interest may complete additional condition-specific outcome measures. All measures will be collected at an enrollment visit (V1), and the intervention will begin 0-14 days thereafter. 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 secondary 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.

Eligibility criteria: Inclusion Criteria:

* Subjects must have the ability to comply with basic instructions and be able to sit still comfortably with the sensor leads attached
* Subjects experiencing symptoms of stress, anxiety, or insomnia, who meet threshold scores on one or more self-reported inventories for the same. This includes the Insomnia Severity Index (ISI, ≥ 8), the Perceived Stress Index (PSS, ≥ 14), or the Generalized Anxiety Disorder 7-item (GAD-7, ≥ 5) scale.

Exclusion Criteria:

* Unable, unwilling, or incompetent to provide informed consent/assent.
* Physically unable to come to the study visits, or to sit comfortably in a chair for up to 1.5 hours.
* Severe hearing impairment (because the subject will be using ear buds during CR).
* Anticipated and ongoing use of alcohol or recreational drugs.
* Weight is over the chair limit (285 pounds).
* Currently in another active intervention research study.
* Prior use of HIRREM, Brainwave Optimization, Cereset, or a wearable configuration of the same (B2, or B2v2).
* Prior use of electroconvulsive therapy (ECT).
* Prior use of transcranial magnetic stimulation (TMS), transcranial direct current stimulation (TDCS), alpha stimulation, neurofeedback, biofeedback, or deep brain stimulation (DBS) within one month before enrollment.
* Known seizure disorder.

Primary outcomes:
measure: Change in Heart Rate Variability
timeFrame: Baseline, V2 (0-14 days after final session), and V3 (4-6 weeks after V2)
measure: Change in Baroreflex Sensitivity
timeFrame: Baseline, V2 (0-14 days after final session), and V3 (4-6 weeks after V2)
measure: Change in Blood Pressure
timeFrame: Baseline, V2 (0-14 days after final session), and V3 (4-6 weeks after V2)
measure: Change in Blood Pressure Variability
timeFrame: Baseline, V2 (0-14 days after final session), and V3 (4-6 weeks after V2)
Secondary outcomes:
measure: Change in Insomnia Severity Index (ISI)
timeFrame: Baseline, V2 (0-14 days after final session), and V3 (4-6 weeks after V2)
measure: Change in Pittsburgh Sleep Quality Index (PSQI)
timeFrame: Baseline, V2 (0-14 days after final session), and V3 (4-6 weeks after V2)
measure: Change in Center for Epidemiologic Studies Depression Scale (CES-D)
timeFrame: Baseline, V2 (0-14 days after final session), and V3 (4-6 weeks after V2)
measure: Change in Generalized Anxiety Disorder-7 (GAD-7)
timeFrame: Baseline, V2 (0-14 days after final session), and V3 (4-6 weeks after V2)
measure: Change in Perceived Stress Scale (PSS)
timeFrame: Baseline, V2 (0-14 days after final session), and V3 (4-6 weeks after V2)
measure: Change in Quality of Life Scale (QOLS)
timeFrame: Baseline, V2 (0-14 days after final session), and V3 (4-6 weeks after V2)
measure: Change in PTSD Checklist for Civilians (PCL-C)
timeFrame: Baseline, V2 (0-14 days after final session), and V3 (4-6 weeks after V2)
measure: Change in International Physical Activity Questionnaire (IPAQ-SF)
timeFrame: Baseline, V2 (0-14 days after final session), and V3 (4-6 weeks after V2)
measure: Change in HIRREM Physical Activity Satisfaction Questions
timeFrame: Baseline, V2 (0-14 days after final session), and V3 (4-6 weeks after V2)
Other outcomes:
Locations:
city: Winston-Salem
country: United States
facility: Department of Neurology, Wake Forest School of Medicine
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: Charles Tegeler, MD
role: PRINCIPAL_INVESTIGATOR
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