Cereset Research Exploratory Study for Dementia Caregivers
Caregivers of a person living with dementia (PLWD) 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 of a person living with dementia. 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.
Conditions:
🦠 Dementia Caregivers
🗓️ Study Start (Actual) 16 June 2022
🗓️ Primary Completion (Estimated) July 2025
✅ Study Completion (Estimated) July 2025
👥 Enrollment (Estimated) 20
🔬 Study Type INTERVENTIONAL
📊 Phase NA
Locations:
📍 Winston-Salem, North Carolina, United States

📋 Eligibility Criteria

Description

    Inclusion Criteria:

    • * participants must provide at least 10 hours of care a week to a person with a diagnosis of dementia (including Alzheimer's disease (early onset or late onset), frontotemporal dementia, Lewy body dementia, Parkinsonian dementia, and mixed dementias)
    • * participants must be willing to provide informed consent
    • * participants have no planned travel during the study period
    • * 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 with dementia
    • * 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 unable to sit comfortably for up to 75 minutes
    • * 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 anticipating ongoing use of alcohol or recreational drugs
    • * 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 of neuromodulation, neurostimulation, deep brain stimulation, neurofeedback, biofeedback, alpha stim, Eye Movement Desensitization and Reprocessing (EMDR),or electroconvulsive therapy within the last month
    • * participants taking Medications that may affect the assessment of heart rate variability (beta blockers. Ongoing need for treatment with opiate, benzodiazepine, or anti-psychotic medications, anti-depressant medications (SSRI, or SNRI's), sleep medications such as zolpidem or eszopiclone, stimulants such as Adderall, Provigil, or Ritalin, or thyroid hormone)
Ages Eligible for Study: 18 Years to N/A (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: Yes

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 12 January 2022
  • First Submitted that Met QC Criteria 12 January 2022
  • First Posted 26 January 2022

Study Record Updates

  • Last Update Submitted that Met QC Criteria 26 July 2024
  • Last Update Posted 30 July 2024
  • Last Verified July 2024