Functional and Physiological Effects of High-resolution, Relational, Resonance-based, Electroencephalic Mirroring (HIRREM) for Neurological, Cardiovascular and Psychophysiological Disorders
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 300
- 试验地点
- 2
- 主要终点
- Heart Rate Variability Standard Deviation of NN Intervals (SDNN)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 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
- •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.
排除标准
- •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.
结局指标
主要结局
Heart Rate Variability Standard Deviation of NN Intervals (SDNN)
时间窗: Baseline/Enrollment visit
Heart rate variability is measured in the time domain as standard deviation of beat-to-beat interval
Baroreflex Sensitivity Sequence Up
时间窗: Up to two weeks after the intervention is completed
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 All
时间窗: Up to 2 weeks after the intervention is completed
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
时间窗: Up to two weeks after the intervention is completed
Analysis is conducted on the first complete 5-minute epoch that is considered to be acceptable for analysis using Nevrokard Baroreflex Sensitivity (BRS) software.
Heart Rate Variability (SDNN)
时间窗: 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
Baroreflex Sensitivity High Frequency (HF) Alpha
时间窗: Up to two weeks after the intervention is completed
Analysis is conducted on the first complete 5-minute epoch that is considered to be acceptable for analysis using Nevrokard Baroreflex Sensitivity (BRS) software.
次要结局
- Insomnia Severity Index (ISI)(4-8 weeks after completion of the intervention)
- Center for Epidemiologic Studies Depression Scale (CES-D)(4-8 weeks after completion of the intervention)
- Drop Stick Reaction Testing(4-8 weeks after completion of the intervention)
- Generalized Anxiety Disorder-7 (GAD-7)(4-8 weeks after completion of the intervention)
- Posttraumatic Stress Disorder Checklist (PCL-C)(enrollment visit/baseline)
- Euro Quality of Life--Five Dimension (EQ-5D)(4-8 weeks after completion of the intervention)
- Posttraumatic Stress Disorder Checklist (PCL)(4-8 weeks after completion of the intervention)
- Rivermead Post-Concussion Symptoms Questionnaire (RPQ)(4-8 weeks after completion of the intervention)