| NCT ID | NCT05209438 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Wake Forest University Health Sciences |
| Condition | Caregivers |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2022-06-16 |
| Primary Completion | 2026-07 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 20 participants in total. It began in 2022-06-16 with a primary completion date of 2026-07.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility 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.
Contact & Investigator
Charles Tegeler, MD
PRINCIPAL INVESTIGATOR
Wake Forest University Health Sciences
Frequently Asked Questions
Who can join the NCT05209438 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Caregivers. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05209438 currently recruiting?
Yes, NCT05209438 is actively recruiting participants. Contact the research team at BBRP@wakehealth.edu for enrollment information.
Where is the NCT05209438 trial being conducted?
This trial is being conducted at Winston-Salem, United States.
Who is sponsoring the NCT05209438 clinical trial?
NCT05209438 is sponsored by Wake Forest University Health Sciences. The principal investigator is Charles Tegeler, MD at Wake Forest University Health Sciences. The trial plans to enroll 20 participants.