Improving health for dementia caregivers using Cereset

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This pilot study aims to evaluate the effects of Cereset Research (CR) on heart rate variability (HRV) and self-reported symptoms of stress, anxiety, and insomnia in caregivers of individuals living with dementia. The study will involve up to 25 participants who provide significant care to dementia patients and experience related stress. Participants will undergo up to three 60-minute CR intervention sessions each week over a four-week period, with assessments of HRV and various psychological inventories conducted before and after the intervention. The goal is to determine if CR can enhance autonomic cardiovascular regulation and improve overall caregiver well-being.

Why it matters

Who can join: the full rules

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.

Where it's running

• Wake Forest University Health Sciences
  Winston-Salem, North Carolina, United States Recruiting

Study contacts

• Principal investigator: Charles Tegeler, MD — Wake Forest University Health Sciences
• Study coordinator: Kenzie Brown
• Email: BBRP@wakehealth.edu
• Phone: 336-716-9447

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.