RecruitingNot ApplicableNCT05209438

Cereset Research for Caregivers

Cereset Research for Caregivers: A Randomized, Controlled Trial

Sponsor

Wake Forest University Health Sciences

Enrollment

20 participants

Start Date

Jun 16, 2022

Study Type

INTERVENTIONAL

Conditions

Caregivers

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a brain-based relaxation technology called Cereset Research for family caregivers who are experiencing stress, anxiety, or sleep problems. The device uses sensors to read your brainwaves and plays back tones through headphones to help your brain self-regulate and calm down. **You may be eligible if...** - You provide at least 10 hours of caregiving per week (any type of caregiving) - You experience symptoms of stress, anxiety, or insomnia that score above certain thresholds on standardized questionnaires - You are able to sit comfortably for up to 90 minutes - You are willing to attend up to three 60-minute sessions per week for 4 weeks **You may NOT be eligible if...** - You have a hearing impairment that prevents you from hearing tones through earbuds - You have a known seizure disorder - You have had suicidal thoughts in the last 3 months - You have a pacemaker or take beta blockers that affect heart rate measurement - You have used this technology in the past 3 years - You weigh more than 400 pounds Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICECereset 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.