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.
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 * To assess the utilization of Cereset Research Wearable (portable, limited scope wearable device) after the CRO intervention. * To assess the participant acceptability of the Cereset Research Intervention.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
CRW is a stress-relaxation device where participants listen to sounds that help to balance brain rhythms. Participants will be asked to come to an office for 5 days over 1-2 weeks, on your their schedule. Sessions will take approximately one (1) hour to complete.
Undergo Cereset research office intervention
Ancillary studies
Number of Completed Interventions
Intervention feasibility will be the number of trial participants who complete the Cereset Research Office intervention (5 out of 5 prescribed sessions).
Time frame: 10 days
Incidence of Adverse Events During Cereset Research Office Intervention
Tolerability will be reported as the total number, grade, time from enrollment and time to resolution of CTCAE and adverse event detected by investigator monitoring and assessment of adverse events at visits 1, 2, 3, and 4 during Cereset Research Office Intervention using the CTCAE 5.0 (Grade 1-5, 1 = mild, 5 = death). Adverse events will be divided into four categories (common adverse events \>15-20%, uncommon adverse events \<15%, rare but potentially serious adverse events and unexpected toxicities). Any Grade 3 toxicity by CTCAE will be further evaluated as an unacceptable event.
Time frame: 4 months
Caregiver Interview
Caregiver interview is a 21-item questionnaire that contains things a person might do when caring for a loved one with cancer. Scores ranges from 1-9 ('1' would state that the participant is not-at-all confident to accomplish the listed behavior; '9' would state that the participant is totally confident to accomplish the listed behavior. Numbers in the middle of the scale indicate that the participant is moderately confident to accomplish the listed behavior). Mean core values for each survey will be calculated for all participants enrolled. Surveys will be provided to participants pre- and post-intervention. Paired student's t-test will be used to compare scores at these V1, V2, V3, V4 time points.
Time frame: 4 months
Generalized Anxiety Disorder 7-item scale (GAD-7)
The Generalized Anxiety Disorder-7 is a validated, short seven item scale. Response scale = (not at all sure = 0; several days = 1; over half the days = 2; to nearly every day = 3). Scores of 5, 10, and 15 are taken as the cut-off points for mild, moderate and severe anxiety, respectively. Mean core values for each survey will be calculated for all participants enrolled. Surveys will be provided to participants pre- and post-intervention. Paired student's t-test will be used to compare scores at these V1, V2, V3, V4 time points
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Ancillary studies
Time frame: 4 months
Insomnia Severity Index (ISI)
The Insomnia Severity Index is a validated, 7 item self-report questionnaire assessing the nature, severity, and impact of insomnia in the past month. Rating scale (0 = very satisfied to 4 = very dissatisfied; 0 = not at all noticeable to 4 = very much noticeable; 0 = not at all worried to 4 = very much worried; 0 = not at all interfering to 4 = very much interfering). Mean core values for each survey will be calculated for all participants enrolled. Surveys will be provided to participants pre- and post-intervention. Paired student's t-test will be used to compare scores at these V1, V2, V3, V4 time points
Time frame: 4 months
Perceived Stress Scale Questionnaire
The Perceived Stress Scale (PSS) is a 10-item psychological instrument for measuring the perception of stress. It is a measure of the degree to which situations in one's life are appraised as stressful. Scale range is 0 = never, 4 = very often. Mean core values for each survey will be calculated for all participants enrolled. Surveys will be provided to participants pre- and post-intervention. Paired student's t-test will be used to compare scores at these V1, V2, V3, V4 time points
Time frame: 4 months
Changes in Heart Rate - FAROS 180 device
Continuous readings of heart rate will be acquired using FAROS 180 heart rate monitor for a minimum of 10 minutes for physiologic changes in heart rate at pre-intervention (B1) and during, and post-intervention time points (B2, B3, B4). The mean values of HRV will be compared with paired student's t-test.
Time frame: 4 months