Improving health for dementia caregivers using Cereset
Cereset Research for Caregivers: A Randomized, Controlled Trial
This study is testing if a new treatment called Cereset can help caregivers of people with dementia feel less stressed, anxious, and improve their sleep.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Wake Forest University Health Sciences Academic / other |
| Locations | 1 site (Winston-Salem, North Carolina) |
| Trial ID | NCT05209438 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are caregivers providing at least 10 hours of care per week to a person with dementia who also report symptoms of stress, anxiety, or insomnia.
Not a fit: Patients who do not provide sufficient caregiving hours or do not experience stress, anxiety, or insomnia may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly reduce stress and improve the health and quality of life for dementia caregivers.
How similar studies have performed: While the specific approach of using Cereset is novel, there is emerging evidence that neuromodulation techniques can positively impact caregiver stress and health outcomes.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Winston-Salem, North Carolina
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.