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Search / Trial NCT05209438

Cereset Research for Caregivers

Launched by WAKE FOREST UNIVERSITY HEALTH SCIENCES · Jan 12, 2022

Trial Information

Current as of July 22, 2025

Recruiting

Keywords

Caregiver Caregiving Stress Anxiety Insomnia Neurotechnology Autonomic Dysregulation Hyperarousal Brain Electrical Activity Allostasis Alzheimer's Dementia Neuromodulation Acoustic Stimulation Heart Rate Variability High Resolution Relational Resonance Based Electroencephalic Mirroring Hirrem Cereset Research

ClinConnect Summary

This clinical trial is exploring a new approach to help caregivers of people living with dementia, as they often experience high levels of stress that can negatively impact their health. The study will investigate whether a treatment called Cereset can improve heart rate variability (HRV), which is a measure of how well the body manages stress. Improved HRV could lead to better overall health for caregivers, helping them feel less stressed, sleep better, and manage their caregiving responsibilities more easily.

To be eligible for this study, participants should provide at least 10 hours of care each week to someone with dementia, such as Alzheimer's or Lewy body dementia, and should be experiencing symptoms of stress, anxiety, or trouble sleeping. They must also be able to attend up to three sessions each week for four weeks, where they will receive the Cereset treatment. Participants will be closely monitored and asked to share how they feel throughout the study. It’s important to note that certain health conditions or medications may exclude someone from participating, but the study aims to provide support and resources for those who need it.

Gender

ALL

Eligibility criteria

  • 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.

About Wake Forest University Health Sciences

Wake Forest University Health Sciences is a leading academic research institution dedicated to advancing healthcare through innovative clinical trials and translational research. With a strong emphasis on multidisciplinary collaboration, the organization leverages its extensive expertise in medical research, patient care, and education to develop and evaluate new therapies and interventions. Committed to improving patient outcomes and public health, Wake Forest University Health Sciences fosters a dynamic environment for scientific inquiry, engaging in a wide range of clinical studies that address pressing health challenges. Through its rigorous methodologies and ethical standards, the institution aims to contribute significantly to the medical field and enhance the quality of life for diverse populations.

Locations

Winston Salem, North Carolina, United States

Winston Salem, North Carolina, United States

Patients applied

0 patients applied

Trial Officials

Charles Tegeler, MD

Principal Investigator

Wake Forest University Health Sciences

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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