Cereset Research for Caregivers (NCT05209438) | Clinical Trial Compass
RecruitingNot Applicable
Cereset Research for Caregivers
United States20 participantsStarted 2022-06-16
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 u…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in Blood Pressure Measurements
Timeframe: Baseline; V3 (4-7 weeks following completion of the intervention)
2
Change in Heart Rate (HR)
Timeframe: Baseline; V3 (4-7 weeks following completion of the intervention)
3
Change in Heart Rate Variability (HRV)
Timeframe: Baseline; V3 (4-7 weeks following completion of the intervention)
4
Change in Baroreflex Sensitivity
Timeframe: Baseline; V3 (4-7 weeks following completion of the intervention)
5
Blood Pressure Variability
Timeframe: Baseline, V3 (4-7 weeks following completion of the intervention)