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Cereset Research for Caregivers

This study is looking at how a device called Cereset Research (CR) might help caregivers who are experiencing stress, anxiety, or trouble sleeping. CR uses sounds to gently echo your brainwaves in real-time. Researchers want to see if CR can improve your heart rate variability (HRV), which is a measure of how well your body handles stress. They will also look at how you feel about your stress, sleep, and caregiving burden. You can join if you are 18 or older, provide at least 10 hours of caregiving per week, and can attend study sessions. The study aims to enroll 20 caregivers, but the current status of enrollment is unclear.

Study design
This is an interventional study planning to enroll 20 caregivers. It is a pilot study to test the effects of Cereset Research.
What's involved
You would need to sit comfortably for up to 90 minutes and attend up to three 60-minute intervention sessions each week for 4 weeks. Your blood pressure, heart rate, and heart rate variability will be measured at the beginning and 4-7 weeks after the intervention.
Compensation
Not stated in the trial record.
Follow-up
Your blood pressure, heart rate, and heart rate variability will be measured 4-7 weeks after you complete the intervention.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05209438

Cereset Research for Caregivers

Recruiting
NAAges 18+InterventionalSupportive care
Wake Forest University Health Sciences
~20 participants
Updated 2026-06-01 on ClinicalTrials.gov
What's tested:Cereset Research

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in Blood Pressure Measurements
Measured over Baseline; V3 (4-7 weeks following completion of the intervention)
+4 more outcomes measured

Conditions

Caregivers

Explore related trials

Caregiver stressors

Where it's being run

1 sites across 1 states
North Carolina1

Study leadership

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

Who to contact

Kenzie Brown
[email protected]
336-716-9447
Email the study team

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • Change in Blood Pressure MeasurementsBaseline; V3 (4-7 weeks following completion of the intervention)

    BP measurements will be obtained using an automate oscillometric blood pressure device. Three samples will be obtained and the last two averaged to get the value that will be used as the reading for that visit.

  • Change in Heart Rate (HR)Baseline; V3 (4-7 weeks following completion of the intervention)

    Continuous heart rate will be recorded while participant is breathing normally in seated position for 10 minutes using Faros 180 heart rate monitor (Bittium Corporation, Oulu, Finland). Beat to beat intervals (RRI) files will be generated at 1000 Hz via the data acquisition software. Files will be analyzed with Nevrokard HRV software (by Nevrokard Kiauta, d.o.o., Izola, Slovenia). Recordings will be visually inspected to ensure data quality (dropped beats or gross motion artifacts are excluded) and first 5 minutes of usable tracings will be analyzed.

  • Change in Heart Rate Variability (HRV)Baseline; V3 (4-7 weeks following completion of the intervention)

    Measures of heart rate variability in frequency domain will be derived and measures integrated over specified frequency ranges (LF: 0.04-0.15 Hz; HF: 0.15-0.4 Hz). Power of RRI spectra in LF, HF range (LFRRI and HFRRI) and total power (TP) will be calculated in normalized units and ratio of LF/HF used as a measure of sympatho-vagal balance.

  • Change in Baroreflex SensitivityBaseline; V3 (4-7 weeks following completion of the intervention)

    BRS calculated by this method is based on quantification of sequences of at least three beats (n) in which Systolic Blood Pressure (SBP) consecutively increases (UP sequence) or decreases (DOWN sequence), which are accompanied by changes in the same direction of the beat-to-beat intervals (RRI) of subsequent beats (n+1). The software scans the RRI and SBP records, identifies sequences, and calculates linear correlation between RRI and SBP for each sequence. The mean of all individual regression coefficients (slopes), a measure of sequence BRS, is calculated for Sequence UP, DOWN and ALL (ms/mmHg).

  • Blood Pressure VariabilityBaseline, V3 (4-7 weeks following completion of the intervention)

    Systolic BP and beat to beat, RR intervals (RRI) files generated via the data acquisition system (BIOPAC acquisition system and software, Santa Barbara, CA) at 1000 Hz are analyzed using Nevrokard SA-BRS software (by Nevrokard Kiauta, d.o.o., Izola, Slovenia) for measures BPV.Frequency Method. Power spectral densities of SBP and RRI oscillations are computed by 512 points Fast Fourier Transform (FFT) and integrated over specified frequency ranges (LF: 0.04-0.15 Hz; HF: 0.15-0.4 Hz).