Cereset Research Exploratory Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Change in Blood Pressure Variability
研究概览
简要总结
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.
详细描述
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 200 participants will be enrolled. Participants will receive between 4 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 also serve as the primary outcome. Secondary outcomes to be collected include symptom inventories for insomnia (Insomnia Severity Index, ISI; depression (Center for Epidemiological Studies- Depression Scale, CES-D), anxiety (Generalized Anxiety Disorder-7, GAD-7), and stress (Perceived Stress Scale, PSS). Other tertiary measures include traumatic stress (PTSD Checklist for civilians, PCL-C, or military, PCL-M), and overall quality of life (QOLS). 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 and appropriate tertiary 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 11 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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).
- •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) within the last 3 years.
- •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.
研究组 & 干预措施
Experimental: Active CR
For this single arm, open label, exploratory trial this will be the intervention arm using active CR.
干预措施: Active CR (Device)
结局指标
主要结局
Change in Blood Pressure Variability
时间窗: Baseline, and V3 (4-6 weeks after V2)
Systolic BP and beat to beat, RR intervals (RRI) files generated via the data acquisition system (BIOPAC acquisition system and software, Santa Barbara, CA) at 1000 Hz are analyzed using Nevrokard SA-BRS software (by Nevrokard Kiauta, d.o.o., Izola, Slovenia) for measures BPV.Frequency Method. Power spectral densities of SBP and RRI oscillations are computed by 512 points Fast Fourier Transform (FFT) and integrated over specified frequency ranges (LF: 0.04-0.15 Hz; HF: 0.15-0.4 Hz).
Change in Heart Rate Variability
时间窗: Baseline, and V3 (4-6 weeks after V2)
Heart rate variability is measured in the time domain as standard deviation of beat-to-beat interval (SDNN, milliseconds). For calculation of SDNN, the R-R intervals are visually inspected, and data considered as artifact is manually removed. Heart rate are acquired from 10 minute recordings of noninvasive finger arterial pressure measurements and ECG with participants lying quietly, supine. Systolic BP and beat to beat, RR intervals files generated via the data acquisition system (BIOPAC acquisition system and Acknowledge 4.2 software, Santa Barbara, CA), at 1000 Hz, are analyzed using Nevrokard BRS software (Nevrokard BRS, Medistar, Ljubljana, Slovenia). Analysis is conducted on the first complete 5-minute epoch that is considered to be acceptable for analysis.
Change in Baroreflex Sensitivity
时间窗: Baseline, and V3 (4-6 weeks after V2)
BRS calculated by this method is based on quantification of sequences of at least three beats (n) in which SBP consecutively increases (UP sequence) or decreases (DOWN sequence), which are accompanied by changes in the same direction of the RRI of subsequent beats (n+1). The software scans the RRI and SBP records, identifies sequences, and calculates linear correlation between RRI and SBP for each sequence. The mean of all individual regression coefficients (slopes), a measure of sequence BRS, is calculated for Sequence UP, DOWN and ALL (ms/mmHg). Blood pressure and heart rate are acquired from 10 minute recordings of noninvasive finger arterial pressure measurements and ECG with participants lying quietly, supine. Systolic BP and beat to beat, RR intervals files generated via the data acquisition system (BIOPAC acquisition system and Acknowledge 4.2 software, Santa Barbara, CA), at 1000 Hz, are analyzed using Nevrokard BRS software (Nevrokard BRS, Medistar, Ljubljana, Slovenia).
次要结局
- Change in Insomnia Severity Index (ISI)(Baseline, V2 (0-14 days after final session), and V3 (4-6 weeks after V2))
- Change in Center for Epidemiologic Studies Depression Scale (CES-D)(Baseline, V2 (0-14 days after final session), and V3 (4-6 weeks after V2))
- Change in Generalized Anxiety Disorder-7 (GAD-7)(Baseline, V2 (0-14 days after final session), and V3 (4-6 weeks after V2))
- Change in Perceived Stress Scale (PSS)(Baseline, V2 (0-14 days after final session), and V3 (4-6 weeks after V2))
- Change in Insomnia Severity Index (ISI)(Baseline, V2 (0-14 days after final session), and V3 (4-6 weeks after V2))
- Change in Center for Epidemiologic Studies Depression Scale (CES-D)(Baseline, V2 (0-14 days after final session), and V3 (4-6 weeks after V2))
- Change in Generalized Anxiety Disorder-7 (GAD-7)(Baseline, V2 (0-14 days after final session), and V3 (4-6 weeks after V2))
- Change in Perceived Stress Scale (PSS)(Baseline, V2 (0-14 days after final session), and V3 (4-6 weeks after V2))