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Cereset Research for Caregivers

Wake Forest University Health Sciences · with Memory Counseling Program general fund, Heidi Munger-Clary, MD · NCT05209438

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 18+ · All sexes
Healthy volunteers
Accepted
Study type
Interventional · Not applicable
Target enrollment
20
US sites recruiting
1
Study start
June 16, 2022
Record last updated
June 1, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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.

Being studied: Cereset Research

Conditions: Caregivers

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full 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.

Recruiting US locations

  • Wake Forest University Health Sciences

    Winston-Salem, NC 27157

    Site contact: Kenzie Brown · 336-716-9447 · BBRP@wakehealth.edu

Study contacts (from the official record)

  • Kenzie Brown · 336-716-9447 · BBRP@wakehealth.edu
  • Charles Tegeler, MD · 336-716-7651 · Charles.Tegeler@wfusm.edu
All sleep studies in North Carolina →
Cereset Research for Caregivers (NCT05209438) | Bored Studies