Dementia Caregivers > Cereset Research

Cereset for Dementia Caregiver Stress

Recruiting in Palo Alto (17 mi)

Overseen By Charles Tegeler, MD

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Wake Forest University Health Sciences

No Placebo Group

Trial Summary

What is the purpose of this trial?

This trial tests if Cereset, a sound-based brain therapy, can help caregivers of people with dementia who are stressed or anxious. The therapy aims to improve how their heart responds to stress by balancing brain activity.

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.

How is the Cereset treatment different from other treatments for dementia caregiver stress?

Cereset is unique because it uses BrainEcho technology, which involves listening to brainwave patterns and providing sound feedback to help the brain relax and reset, unlike traditional stress reduction methods like mindfulness or support groups.

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Eligibility Criteria

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.

Exclusion Criteria

I cannot sit comfortably for 75 minutes.

I have not felt at risk of suicide in the last 3 months.

I cannot or do not want to attend the study sessions.

I have had seizures or suicidal thoughts in the last 3 months.

Participant Groups

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.

Group I: Cereset Research Active Control 1 Intervention

This will be the active intervention arm using 6 Cereset (CR) sessions and participants will continue current care.

Group II: Control Placebo Group 1 Intervention

Participants will have 6 CR sessions of sham control tones and also continue their current care.

Find A Clinic Near You

Research locations nearby Select from list below to view details:

Wake Forest Baptist Health Winston-Salem, NC

Who is running the clinical trial?

Wake Forest University Health Sciences Lead Sponsor

Memory Counseling Program general fund Collaborator

Heidi Munger-Clary, MD Collaborator

Hossam Shaltout, PhD Collaborator

Sean Simpson, PhD Collaborator

Christina Hugenschmidt, PhD Collaborator

Mia Yang, MD Collaborator

References

1. United States pubmed.ncbi.nlm.nih.gov

Mindfulness-based stress reduction for family caregivers: a randomized controlled trial. [2022] Caring for a family member with dementia is associated with chronic stress, which can have significant deleterious effects on caregivers. The purpose of the Balance Study was to compare a mindfulness-based stress reduction (MBSR) intervention to a community caregiver education and support (CCES) intervention for family caregivers of people with dementia.

2. United States pubmed.ncbi.nlm.nih.gov

Overwhelmed: a Dementia Caregiver Vital Sign. [2023] The emotional stress of caring for someone with Alzheimer's disease and related dementias is high and results in adverse effects on caregivers and the persons living with disease. In preliminary work, caregiver reports of regularly feeling "completely overwhelmed" were associated with lack of measurable clinical benefit from a comprehensive dementia care program.

3. United States pubmed.ncbi.nlm.nih.gov

Implementation and evaluation of a self-care toolkit for caregivers of families with dementia. [2023] Family caregivers who care for individuals with dementia are more likely to develop chronic stress, major depression, anxiety, and physical health disorders and they have a higher mortality rate compared with the general population.

4. Brazil pubmed.ncbi.nlm.nih.gov

Behavior disorders and subjective burden among caregivers of demented patients. [2022] Many patients with dementia live within the community supported by their family and friends. Majority of patient caregivers suffer from high levels of stress.

5. United States pubmed.ncbi.nlm.nih.gov

Berlin Inventory of Caregiver Stress-Dementia (BICS-D). [2021] Dementia is becoming increasingly prevalent and family caregivers have been providing most of the care for persons with dementia. This caregiving is a mentally and physically demanding task. "The Berlin Inventory of Caregiver Stress-Dementia" (BICS-D) is a theory driven, multidimensional assessment which was developed as part of the Longitudinal Dementia Caregiver Stress Study (LEANDER).