Can We Relieve the Stress: Cereset for Caregivers
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- Number of Completed Interventions
研究概览
简要总结
In this single arm, open label study, investigators will evaluate the feasibility of using the Cereset (formerly known as HIRREM - high-resolution relational, resonance-based electroencephalic mirroring) intervention for a stressed population confronting an acute burden on their lives - caregivers of newly diagnosed high-grade glioma patients. The Cereset intervention is a closed-loop acoustic stimulation intervention that has been studied in patients with PTSD, insomnia, postural orthostatic tachycardia, and military veterans.
详细描述
Primary Objective:
• To determine the feasibility of completing the prescribed Cereset Research Office intervention for trial participants in this single arm, open label study.
Secondary Objectives
- To assess the tolerability of the intervention
- To assess changes in trial participant wellbeing and quality of life.
- To assess changes in physiological response at pre-intervention and post-intervention time points.
Exploratory Objectives
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •≥18 years of age
- •Identified as caregiver by patient with glioma as defined as the primary, non-professional, non-paid person who provides the majority of emotional financial and/or physical support. There will only be one trial participant allowed per patient/caregiver dyad.
- •The trial participant must be caring for a patient who is:
- •≥18 years of age
- •Has a histologically confirmed malignancy that is a high grade glioma which includes (astrocytoma, oligodendroglioma, glioblastoma, ependymoma).
- •Any World Health Organization (WHO) grade gliomas
- •Trial participant is able to understand and the willingness to sign an IRB-approved informed consent document.
- •Trial participant is able to sit in a chair for 90 minutes.
排除标准
- •Trial participant is a heavy alcohol user per the Substance Abuse and Mental Health Services Administration.
- •Heavy alcohol use is defined as binge drinking on 5 or more days in the past month.
- •Binge drinking is defined as 4 drinks for women and 5 drinks for men on the same occasion.
- •Trial participant has severe hearing impairment defined as word discrimination at <50% with or without the use of hearing aids.
- •Trial participant's weight is greater than or equal to 400 pounds at time of enrollment (chair limit).
- •Prior trial participant 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.
- •Trial participant has previously used HIRREM, or Cereset.
- •Trial participant has a known seizure disorder requiring ongoing anti-epileptics prescribed specifically for seizure disorder.
- •Trial participant states he or she will not be able to abstain from daily use of alcohol or recreational drugs during the intervention period.
结局指标
主要结局
Number of Completed Interventions
时间窗: 10 days
Intervention feasibility will be the number of trial participants who complete the Cereset Research Office intervention (5 out of 5 prescribed sessions).
次要结局
- Incidence of Adverse Events During Cereset Research Office Intervention(4 months)
- Generalized Anxiety Disorder 7-item scale (GAD-7)(4 months)
- Perceived Stress Scale Questionnaire(4 months)
- Caregiver Interview(4 months)
- Insomnia Severity Index (ISI)(4 months)
- Changes in Heart Rate - FAROS 180 device(4 months)