Recruiting

Observational Study

Sponsor:

Wake Forest University Health Sciences

Code:

NCT05209438

Conditions

Caregivers

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Cereset Research

Study Details

Brief summary:

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.

Conditions

Caregivers

Study ID

NCT05209438

Start date

Jun 16, 2022

Status verified date

May, 2026

Completion date

Dec, 2027

Anticipated

Primary completion date

Jul, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • Participants must provide caregiving at least 10 hours per week. This includes all types of caregiving
  • participants must be willing to provide informed consent
  • 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
  • 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 not exhibiting symptoms of stress, anxiety or insomnia
  • participants with hearing impairment severe enough that they cannot perceive tones through ear buds
  • 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 (past 3 years) of the technology being tested
  • 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
  • Pace makers and beta blockers that affect the assessment of heart rate variability will also be exclusionary
  • participants taking Medications that may affect the assessment of heart rate variability (beta blockers.

Study Design

Enrollment

20 participants

Anticipated

Allocation

Randomized

Intervention Model

Single group

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

active comparator: Cereset Research

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

sham comparator: Control

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

Interventions

Cereset Research

Cereset Research The upgraded platform for medical research using the HIRREM technology has been rebranded as Cereset Research® (CR). This system uses the same core technology and algorithms to echo brainwaves in real-time using audible tones, as with HIRREM. The CR system also includes 64-bit processing architecture for faster feedback, the use of 4 sensors, and the use of standard protocols (with flexibility regarding the length and sequencing of the standard protocols), all done with eyes closed. Four sensors are applied to the scalp at a time. However, only two sensors are actively echoing feedback. The software automatically switches from one sensor pair to the other when needed. This reduces the number of sensor placement changes needed, resulting in shorter session time and fewer interruptions.

Primary outcome measure

  • Change in Blood Pressure Measurements [ Time Frame: Baseline; V3 (4-7 weeks following completion of the intervention) ]
  • Change in Heart Rate (HR) [ Time Frame: Baseline; V3 (4-7 weeks following completion of the intervention) ]
  • Change in Heart Rate Variability (HRV) [ Time Frame: Baseline; V3 (4-7 weeks following completion of the intervention) ]
  • Change in Baroreflex Sensitivity [ Time Frame: Baseline; V3 (4-7 weeks following completion of the intervention) ]
  • Blood Pressure Variability [ Time Frame: Baseline, V3 (4-7 weeks following completion of the intervention) ]

Central Contacts and Locations

Central contacts

Kenzie Brown

336-716-9447BBRP@wakehealth.edu

Charles Tegeler, MD

336-716-7651Charles.Tegeler@wfusm.edu

Locations

Wake Forest University Health Sciences

Recruiting

Winston-Salem, North Carolina, United States, 27157

Contacts

Kenzie Brown

336-716-9447BBRP@wakehealth.edu

More Information

Sponsor

Wake Forest University Health Sciences

Last update posted

Jun 1, 2026

Last verified

May, 2026

Keywords

  • 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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Wake Forest University Health Sciences on 2026-06-01.