Cereset for Dementia Caregiver Stress

Recruiting at 1 trial location

Overseen By Kenzie Brown

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Wake Forest University Health Sciences

Must not be taking: Beta blockers, Opiates, Antidepressants, others

Disqualifiers: Hearing impairment, Seizure disorder, Suicidal thoughts, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

20 Participants Needed

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. ^{1 2 3 4 5}

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. ^{1 3 4 5 6}

Who Is on the Research Team?

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

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

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?

Group I: Cereset Research Active Control 1 Intervention

This will be the active intervention arm using 4 Cereset (CR) sessions and participants will continue current care.

Group II: Control Placebo Group 1 Intervention

Participants will have 4 CR sessions of sham control tones and also continue their current care.

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Behavior disorders and subjective burden among caregivers of demented patients. Eloah, LFC., Bertolucci, PHF., Minett, TSC.[2022]

The Balance Study, involving 78 family caregivers of individuals with dementia, found that mindfulness-based stress reduction (MBSR) significantly improved mental health, reduced stress, and decreased depression compared to community caregiver education and support (CCES).

Both MBSR and CCES were effective in enhancing caregiver mental health, but MBSR showed superior benefits, suggesting it could be a valuable intervention for caregivers dealing with the chronic stress of caring for a family member with dementia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mindfulness-based stress reduction for family caregivers: a randomized controlled trial. Whitebird, RR., Kreitzer, M., Crain, AL., et al.[2022]

Caregivers who reported feeling 'completely overwhelmed' at the start of a comprehensive dementia care program experienced significantly higher levels of distress, depression, and burden compared to those who did not feel overwhelmed, indicating a need for targeted support.

Despite the high levels of distress among overwhelmed caregivers, their feelings did not predict long-term outcomes such as nursing home placement or mortality for the patients they care for, suggesting that caregiver support may be crucial without directly impacting patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Overwhelmed: a Dementia Caregiver Vital Sign. Reuben, DB., Romero, T., Evertson, LC., et al.[2023]

Citations

1.

withpower.com

withpower.com/trial/phase-dementia-caregivers-4-2022-df058

Cereset for Dementia Caregiver Stress

This trial tests if Cereset, a sound-based brain therapy, can help caregivers of people with dementia who are stressed or anxious.

2.

withpower.com

withpower.com/trial/phase-glioma-10-2021-75fb6

Cereset for Caregiver Stress · Info for Participants

A 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 ...

3.

school.wakehealth.edu

school.wakehealth.edu/departments/neurology/brain-body-research-program/cereset-research/research-to-date

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.

4.

cereset.com

cereset.com/research/

Cereset research

A Natural Non-invasive Neuro-technology Improves Sleep and Wellbeing in Randomized, Controlled Clinical Trial · Cereset Research Exposes the Secrets of Traumatic ...

5.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11036232/

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, ...

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC7353905/

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 ...