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RECRUITING

NCT05209438

Cereset Research for Caregivers

Sponsor: Wake Forest University Health Sciences

View on ClinicalTrials.gov

Summary

Caregivers experience high levels of prolonged stress that can lead to chronic problems with health, including increased risk of cardiovascular disease that is linked to autonomic dysregulation. Heart rate variability (HRV), measures of autonomic cardiovascular regulation, is decreased (worse) in caregivers. Autonomic function is linked to lateralization in the brain, and emerging neuromodulation methods that target lateralized signals in the brain, like Cereset (CR), may be able to improve heart rate variability. Therefore, this pilot study aims to test whether CR can improve HRV in caregivers of a person living with dementia experiencing stress, anxiety, or insomnia, as well as improve self-report measures of stress, sleep and caregiver burden.

Official title: Cereset Research for Caregivers: A Randomized, Controlled Trial

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

Start Date

2022-06-16

Completion Date

2026-07

Last Updated

2025-07-15

Healthy Volunteers

Yes

Conditions

Caregivers

Interventions

DEVICE

Cereset Research

Cereset Research The upgraded platform for medical research using the HIRREM technology has been rebranded as Cereset Research® (CR). This system uses the same core technology and algorithms to echo brainwaves in real-time using audible tones, as with HIRREM. The CR system also includes 64-bit processing architecture for faster feedback, the use of 4 sensors, and the use of standard protocols (with flexibility regarding the length and sequencing of the standard protocols), all done with eyes closed. Four sensors are applied to the scalp at a time. However, only two sensors are actively echoing feedback. The software automatically switches from one sensor pair to the other when needed. This reduces the number of sensor placement changes needed, resulting in shorter session time and fewer interruptions.

Inclusion Criteria: * Participants must provide caregiving at least 10 hours per week. This includes all types of caregiving * participants must be willing to provide informed consent * participants must be able to comply with basic instructions * participants must be able to sit comfortably for up to 90 minutes, and attend up to three 60-minute intervention sessions each week during the 4-week intervention period * participants must self report experiencing symptoms of stress, anxiety, or insomnia and meet threshold scores on one or more self-report inventories of these symptoms (Insomnia Severity Index (ISI, ≥ 8), the Perceived Stress Index (PSS, ≥ 14), or the Generalized Anxiety Disorder 7-item (GAD-7, ≥ 5) scale) Exclusion criteria: * participants providing less than 10 hours a week of care to a person * participants who are unable or unwilling to attend intervention sessions during the planned study period * participants who are unable or unwilling to provide consent * participants who are not exhibiting symptoms of stress, anxiety or insomnia * participants with hearing impairment severe enough that they cannot perceive tones through ear buds * participants with known seizure disorder, or suicidal thoughts within the last 3 months * participants who respond positively to a question about risk for suicide within the last 3 months will be excluded and receive a behavioral health resource list * participants weighing more than 400 pounds (the weight limit of the chair used during intervention) * participants currently enrolled in another intervention study * prior use (past 3 years) of the technology being tested * prior use of neuromodulation, neurostimulation, deep brain stimulation, neurofeedback, biofeedback, alpha stim, Eye Movement Desensitization and Reprocessing (EMDR),or electroconvulsive therapy within the last month * Pace makers and beta blockers that affect the assessment of heart rate variability will also be exclusionary * participants taking Medications that may affect the assessment of heart rate variability (beta blockers.

Locations (1)

Wake Forest University Health Sciences

Winston-Salem, North Carolina, United States