High-Resolution, Relational, Resonance-Based, Electroencephalic Mirroring (HIRREM) for Stage 1 Primary Hypertension
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 5
- 试验地点
- 1
- 主要终点
- Change From Baseline in Blood Pressure, as Measured by an Automated Oscillometric Blood Pressure Device.
研究概览
简要总结
The purpose of this study is to determine that effects of an intervention called High-resolution, relational, resonance-based, electroencephalic mirroring (HIRREM), on Stage 1 Primary Hypertension (systolic BP 130-139, and/or diastolic BP 80-89).
详细描述
The purpose of this research study is to determine the effects of a technique called High-resolution, relational, resonance-based, electroencephalic mirroring (HIRREM®), for hypertension. HIRREM uses scalp sensors to monitor brain electrical activity, and computer software algorithms translate selected brain frequencies into audible tones in real time. Those tones are reflected back to participants via ear buds in as little as four to eight milliseconds, providing the brain an opportunity for self-adjustment of its electrical pattern.
This study will compare acoustic stimulation linked to brainwave activity (HIRREM, along with continued current care, HCC), with continued current clinical care alone (CCC). Both groups will continue their other current care throughout, including non-pharmacological, and lifestyle modification therapies.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults, age 18 and above
- •Systolic BP ranging from 130-139mmHg and/or diastolic BP ranging from 80-89mmHg
排除标准
- •Unable, unwilling, or incompetent to provide informed consent
- •Physically unable to come to the study visits, or to sit comfortably in a chair for up to two hours at a time
- •Weight is over the chair limit (285 pounds)
- •Known atherosclerotic cardiovascular disease
- •Cardiovascular risk score of ≥ 10% (per http://tools.acc.org/ASCVD-Risk-Estimator-Plus/#!/calculate/estimate/)
- •Prior diagnosis of stage 2 hypertension
- •Ongoing need for treatment of hypertension with medications
- •Known seizure disorder
- •Known or anticipated pregnancy
- •Severe hearing impairment (because the subject will be using headphones during the interventions)
- •Ongoing need for treatment with opiate, benzodiazepine, or anti-psychotic medications, anti-depressant medications such as SSRI, SNRI, or tricyclic, and sleep medications such as zolpidem or eszopiclone
- •Anticipated and ongoing use of recreational drugs, alcohol, or energy drinks
- •Ongoing need for treatment with thyroid medications
- •Are enrolled in another research study that includes an active intervention
- •Have previously received brainwave optimization (BWO), used a B2 or B2v2 wearable device, or previously participated in a HIRREM research study
研究组 & 干预措施
HIRREM
High-resolution, relational, resonance-based, electroencephalic mirroring (HIRREM) is a novel, noninvasive, closed-loop, brainwave mirroring, acoustic stimulation neurotechnology to support relaxation and auto-calibration of neural oscillations, using auditory tones to reflect brain frequencies in near real time.
干预措施: HIRREM (Device)
HIRREM
High-resolution, relational, resonance-based, electroencephalic mirroring (HIRREM) is a novel, noninvasive, closed-loop, brainwave mirroring, acoustic stimulation neurotechnology to support relaxation and auto-calibration of neural oscillations, using auditory tones to reflect brain frequencies in near real time.
干预措施: Continued Current Care (Other)
Continued Current Care
Participants will continue their current care.
干预措施: HIRREM (Device)
Continued Current Care
Participants will continue their current care.
干预措施: Continued Current Care (Other)
结局指标
主要结局
Change From Baseline in Blood Pressure, as Measured by an Automated Oscillometric Blood Pressure Device.
时间窗: Baseline to V3 (4-6 weeks following completion of the intervention for HCC, 8-10 weeks after V1 for CCC).
BP will be obtained in the left arm, with the participant sitting comfortably, and the left arm resting on a desk/table. Three samples will be obtained and the last two averaged to get the value that will be used as the reading. Primary outcome will be at V3 (4-6 weeks post final session).
次要结局
- Change in Heart Rate Variability (SDNN)(Baseline to V3 (4-6 weeks following completion of the intervention for HCC, 8-10 weeks after V1 for CCC).)
- Change in Insomnia Severity Index (ISI)(Baseline to V3 (4-6 weeks following completion of the intervention for HCC, 8-10 weeks after V1 for CCC).)
- Change in PTSD Checklist for Civilians (PCL-C)(Baseline to V3 (4-6 weeks following completion of the intervention for HCC, 8-10 weeks after V1 for CCC).)
- Change in HIRREM Physical Activity Satisfaction Questions(Baseline to V3 (4-6 weeks following completion of the intervention for HCC, 8-10 weeks after V1 for CCC).)
- Change in Drop Stick Reaction Time(Baseline to V3 (4-6 weeks following completion of the intervention for HCC, 8-10 weeks after V1 for CCC).)
- Change in Quality of Life Scale (QOLS)(Baseline to V3 (4-6 weeks following completion of the intervention for HCC, 8-10 weeks after V1 for CCC).)
- Change in Generalized Anxiety Disorder-7 (GAD-7)(Baseline to V3 (4-6 weeks following completion of the intervention for HCC, 8-10 weeks after V1 for CCC).)
- Change in Perceived Stress Scale (PSS)(Baseline to V3 (4-6 weeks following completion of the intervention for HCC, 8-10 weeks after V1 for CCC).)
- Change in Baroreflex Sensitivity(Baseline to V3 (4-6 weeks following completion of the intervention for HCC, 8-10 weeks after V1 for CCC).)
- Change in Pittsburgh Sleep Quality Index (PSQI)(Baseline to V3 (4-6 weeks following completion of the intervention for HCC, 8-10 weeks after V1 for CCC).)
- Change in Epworth Sleepiness Score (ESS)(Baseline to V3 (4-6 weeks following completion of the intervention for HCC, 8-10 weeks after V1 for CCC).)
- Change in Center for Epidemiologic Studies Depression Scale (CES-D)(Baseline to V3 (4-6 weeks following completion of the intervention for HCC, 8-10 weeks after V1 for CCC).)
- Change in International Physical Activity Questionnaire (IPAQ-SF)(Baseline to V3 (4-6 weeks following completion of the intervention for HCC, 8-10 weeks after V1 for CCC).)
- Change in Grip Strength(Baseline to V3 (4-6 weeks following completion of the intervention for HCC, 8-10 weeks after V1 for CCC).)