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New treatment option for Caregivers
Official title Cereset Research for Caregivers
ClinicalTrials.gov ID: NCT05209438
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older. Healthy volunteers may be eligible.
You may be able to join 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...
- participants must self report experiencing symptoms of stress, anxiety, or insomnia and meet threshold scores on one or more self-report inventories...
You likely can't join 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
See the full eligibility 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...
- 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 study team makes the final eligibility decision.
Where it's taking place
- Winston-Salem, North Carolina, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Winston-Salem, North Carolina, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.