NCT05209438 · RECRUITING
Cereset Research for Caregivers
This small pilot study tests whether Cereset, a device that plays sound tones through ear buds while tracking brain activity, can improve heart rate variability in stressed caregivers of people with dementia. It also looks at self-reported stress, sleep, and caregiver burden. It is an early pilot, so it is not proven or approved for anything.
You may qualify if
- 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)
You're excluded if
- 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.
The sponsor's own eligibility wording, lightly reformatted. The study team makes the final eligibility decision — worth discussing with your doctor.
Eligibility criteria as of 2026-06-01