Actively Recruiting
Cereset Research for Caregivers
Led by Wake Forest University Health Sciences · Updated on 2025-07-15
20
Participants Needed
1
Research Sites
210 weeks
Total Duration
On this page
Sponsors
W
Wake Forest University Health Sciences
Lead Sponsor
M
Memory Counseling Program general fund
Collaborating Sponsor
AI-Summary
What this Trial 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.
CONDITIONS
Official Title
Cereset Research for Caregivers
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants must provide caregiving at least 10 hours per week, including 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 symptoms of stress, anxiety, or insomnia and meet threshold scores on one or more self-report inventories (Insomnia Severity Index 9, Perceived Stress Scale 14, or Generalized Anxiety Disorder 7-item scale 5)
You will not qualify if you...
- Participants providing less than 10 hours a week of care
- Participants unable or unwilling to attend intervention sessions during the study period
- Participants unable or unwilling to provide consent
- Participants not exhibiting symptoms of stress, anxiety, or insomnia
- Participants with severe hearing impairment preventing perception of tones through earbuds
- Participants with known seizure disorder or suicidal thoughts within the last 3 months
- Participants who respond positively to suicide risk screening within the last 3 months
- Participants weighing more than 400 pounds (weight limit of intervention chair)
- Participants currently enrolled in another intervention study
- Prior use of the tested technology in the past 3 years
- Prior use within the last month of neuromodulation, neurostimulation, deep brain stimulation, neurofeedback, biofeedback, alpha stim, EMDR, or electroconvulsive therapy
- Participants with pacemakers or taking beta blockers that affect heart rate variability assessment
- Participants taking medications that may affect heart rate variability assessment (beta blockers)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States, 27157
Actively Recruiting
Research Team
K
Kenzie Brown
CONTACT
C
Charles Tegeler, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here