20 Participants Needed

Cereset for Dementia Caregiver Stress

Recruiting at 1 trial location
DH
CT
KB
Overseen ByKenzie Brown
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether a treatment called Cereset can reduce stress, anxiety, and insomnia in caregivers of individuals with dementia. Cereset uses sound tones to improve heart rate variability, a measure linked to heart health and stress management. The trial includes two groups: one receiving the actual Cereset treatment and another receiving a sham or placebo version. It suits caregivers who spend at least 10 hours a week caring for someone and struggle with stress, anxiety, or sleep issues. Participants must be comfortable sitting for sessions and willing to attend weekly treatments. As an unphased trial, this study offers caregivers an opportunity to explore a novel approach to managing stress and improving well-being.

Will I have to stop taking my current medications?

Yes, you may need to stop taking certain medications. The trial excludes participants taking medications that affect heart rate variability, such as beta blockers, opiates, benzodiazepines, antipsychotics, antidepressants, sleep medications, stimulants, or thyroid hormones.

What prior data suggests that Cereset is safe for improving heart rate variability in dementia caregivers?

Research has shown that Cereset, a therapy using sound, was tested for safety in earlier studies. Participants generally handled it well, with no serious side effects reported. This treatment uses sound to balance brain activity and evolved from an earlier method called HIRREM, which also aimed to reduce stress with sound. As a non-invasive method, it avoids medications or surgery, reducing the risk of negative reactions. Although this specific trial remains in its early stages, the safety record of similar treatments suggests that participants are unlikely to experience severe negative effects.12345

Why are researchers excited about this trial?

Researchers are excited about Cereset for dementia caregiver stress because it offers a non-invasive, technology-based approach to managing stress. Unlike traditional methods like medication or therapy, Cereset uses audio tones to help reset brain rhythms, potentially reducing stress without side effects. This innovative mechanism targets the brain's natural frequencies, aiming to restore balance and improve overall well-being.

What evidence suggests that Cereset is effective for improving heart rate variability in dementia caregivers?

Research has shown that Cereset, a therapy using sound, might help reduce stress and anxiety in people caring for those with dementia. In this trial, some participants will receive the active Cereset intervention, while others will be in a control group receiving sham control tones. Users of Cereset have reported better sleep and overall well-being. This therapy targets brain signals related to stress and how the body automatically manages functions like heart rate. Although specific results for dementia caregivers are still under study, early findings suggest that Cereset can improve heart rate variability, an indicator of stress and heart health. These improvements might help reduce the stress experienced by caregivers.13456

Who Is on the Research Team?

CT

Charles Tegeler, MD

Principal Investigator

Wake Forest University Health Sciences

Are You a Good Fit for This Trial?

This study is for caregivers providing at least 10 hours of care weekly to someone with dementia and experiencing stress, anxiety, or insomnia. They must be able to sit for up to 90 minutes, attend three sessions a week over four weeks, and not have plans to travel during the study. Those using certain medications or with conditions like seizure disorders or severe hearing impairment cannot participate.

Inclusion Criteria

I provide 10+ hours of care weekly to someone with dementia.
I feel stressed, anxious, or have trouble sleeping and my scores on related tests are high.
Participants must be willing to provide informed consent
See 3 more

Exclusion Criteria

I cannot sit comfortably for 75 minutes.
Participants with hearing impairment severe enough that they cannot perceive tones through earbuds
Participants anticipating ongoing use of alcohol or recreational drugs
See 10 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants undergo 6 Cereset (CR) sessions to evaluate the effect on autonomic cardiovascular regulation and self-reported symptoms

6 weeks

Follow-up

Participants are monitored for changes in heart rate variability, blood pressure, and self-reported symptoms

4-7 weeks
2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

  • Cereset Research
Trial Overview The trial tests Cereset (CR), a neuromodulation method aimed at improving heart rate variability (HRV) in dementia caregivers under stress. It explores whether CR can enhance autonomic cardiovascular regulation through brain lateralization targeting techniques over several sessions.
How Is the Trial Designed?
2Treatment groups
Active Control
Placebo Group
Group I: Cereset ResearchActive Control1 Intervention
Group II: ControlPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Wake Forest University Health Sciences

Lead Sponsor

Trials
1,432
Recruited
2,506,000+

Memory Counseling Program general fund

Collaborator

Trials
1
Recruited
20+

Heidi Munger-Clary, MD

Collaborator

Trials
1
Recruited
20+

Hossam Shaltout, PhD

Collaborator

Trials
1
Recruited
20+

Sean Simpson, PhD

Collaborator

Trials
1
Recruited
20+

Christina Hugenschmidt, PhD

Collaborator

Trials
1
Recruited
20+

Mia Yang, MD

Collaborator

Trials
1
Recruited
20+

Published Research Related to This Trial

A study involving 35 family caregivers of individuals with dementia showed that an evidence-based educational class significantly reduced caregiver stress, with 70% of those initially at high risk for stress moving to a low-risk category after the intervention.
The project highlights the importance of providing educational resources and support to caregivers, suggesting that such interventions can improve their health and well-being, and should be integrated into primary care practices.
Implementation and evaluation of a self-care toolkit for caregivers of families with dementia.Smith, CW., Graves, BA.[2023]
The Berlin Inventory of Caregiver Stress-Dementia (BICS-D) is a reliable and valid tool for assessing the multidimensional stress experienced by caregivers of individuals with dementia, based on a study involving 594 caregivers.
The inventory can differentiate the burden experienced by various caregiver subgroups (like partners and children) and is sensitive to changes in caregiver stress, making it useful for evaluating interventions.
Berlin Inventory of Caregiver Stress-Dementia (BICS-D).Schlomann, A., Schacke, C., Leipold, B., et al.[2021]
Nursing interventions significantly reduced behavioral disturbances in patients with moderate to severe dementia, including aggression and anxiety, over an 18-month period with a sample of 31 subjects.
Caregiver distress also decreased as a result of these interventions, highlighting the potential benefits of education programs that inform caregivers about managing dementia-related challenges.
Behavior disorders and subjective burden among caregivers of demented patients.Eloah, LFC., Bertolucci, PHF., Minett, TSC.[2022]

Citations

Cereset for Dementia Caregiver StressThis trial tests if Cereset, a sound-based brain therapy, can help caregivers of people with dementia who are stressed or anxious.
Cereset for Caregiver Stress · Info for ParticipantsA systematic review of 24 trials (8 open-label and 16 randomized) found that internet-based interventions can effectively reduce caregiver stress, with 6 out of ...
Research to Date - Cereset Research | Wake Forest University ...Cereset Research for Caregivers – This ongoing exploratory study will evaluate the effects of CR in caregivers with symptoms of stress, anxiety, or insomnia.
Cereset researchA Natural Non-invasive Neuro-technology Improves Sleep and Wellbeing in Randomized, Controlled Clinical Trial · Cereset Research Exposes the Secrets of Traumatic ...
Interventions Effective in Decreasing Burden in Caregivers ...Based on the above, this paper seeks to identify which interventions can improve the health of the primary caregiver of patients with dementia, ...
Stress in the Volunteer Caregiver: Human-Centric ...The interview data shows that some behaviors exhibited by the dementia patient caused more stress in the home-based caregiver than did other behaviors. On a ...
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