RECRUITING

Cereset Research for Caregivers

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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. 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.

Official Title

Cereset Research for Caregivers: A Randomized, Controlled Trial

Quick Facts

Study Start:2022-06-16
Study Completion:2026-07
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05209438

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Participants must provide caregiving at least 10 hours per week. This includes all types of caregiving
  2. * participants must be willing to provide informed consent
  3. * participants must be able to comply with basic instructions
  4. * 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
  5. * 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)
  1. * participants providing less than 10 hours a week of care to a person
  2. * participants who are unable or unwilling to attend intervention sessions during the planned study period
  3. * participants who are unable or unwilling to provide consent
  4. * participants who are not exhibiting symptoms of stress, anxiety or insomnia
  5. * participants with hearing impairment severe enough that they cannot perceive tones through ear buds
  6. * participants with known seizure disorder, or suicidal thoughts within the last 3 months
  7. * 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
  8. * participants weighing more than 400 pounds (the weight limit of the chair used during intervention)
  9. * participants currently enrolled in another intervention study
  10. * prior use (past 3 years) of the technology being tested
  11. * 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
  12. * Pace makers and beta blockers that affect the assessment of heart rate variability will also be exclusionary
  13. * participants taking Medications that may affect the assessment of heart rate variability (beta blockers.

Contacts and Locations

Study Contact

Kenzie Brown
CONTACT
336-716-9447
BBRP@wakehealth.edu
Charles Tegeler, MD
CONTACT
336-716-7651
ctegeler@wakehealth.edu

Principal Investigator

Charles Tegeler, MD
PRINCIPAL_INVESTIGATOR
Wake Forest University Health Sciences

Study Locations (Sites)

Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157
United States

Collaborators and Investigators

Sponsor: Wake Forest University Health Sciences

  • Charles Tegeler, MD, PRINCIPAL_INVESTIGATOR, Wake Forest University Health Sciences

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

Study Start Date2022-06-16
Study Completion Date2026-07

Study Record Updates

Study Start Date2022-06-16
Study Completion Date2026-07

Terms related to this study

Keywords Provided by Researchers

  • caregiver
  • caregiving
  • stress
  • anxiety
  • insomnia
  • neurotechnology
  • autonomic dysregulation
  • hyperarousal
  • brain electrical activity
  • allostasis
  • Alzheimer's
  • dementia
  • neuromodulation
  • acoustic stimulation
  • heart rate variability
  • High-resolution relational resonance-based electroencephalic mirroring HIRREM
  • Cereset Research

Additional Relevant MeSH Terms

  • Caregivers