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.
研究组 & 干预措施
Intervention with Ambulatory Therapy
Caregivers of participants with high-grade glioma will undergo standard Cereset Research Office (CRO) in-office treatment for a total of five (5) treatments. Ambulatory therapy with the Cereset Research Wearable (CRW) will be available to caregivers while they are attending routine radiation therapy with glioma patients.
干预措施: Cereset Research Wearable (Device)
Intervention with Ambulatory Therapy
Caregivers of participants with high-grade glioma will undergo standard Cereset Research Office (CRO) in-office treatment for a total of five (5) treatments. Ambulatory therapy with the Cereset Research Wearable (CRW) will be available to caregivers while they are attending routine radiation therapy with glioma patients.
干预措施: Stress management therapy (Procedure)
Intervention with Ambulatory Therapy
Caregivers of participants with high-grade glioma will undergo standard Cereset Research Office (CRO) in-office treatment for a total of five (5) treatments. Ambulatory therapy with the Cereset Research Wearable (CRW) will be available to caregivers while they are attending routine radiation therapy with glioma patients.
干预措施: Questionnaire administration (Other)
Intervention with Ambulatory Therapy
Caregivers of participants with high-grade glioma will undergo standard Cereset Research Office (CRO) in-office treatment for a total of five (5) treatments. Ambulatory therapy with the Cereset Research Wearable (CRW) will be available to caregivers while they are attending routine radiation therapy with glioma patients.
干预措施: Quality of Life Assessment (Other)
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)