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CaregiversNCT05209438

Cereset Research for Caregivers

A study testing Cereset Research in people with Caregivers, run by Wake Forest University Health Sciences at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Caregivers
What is being tested?
Cereset Research
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
20 participants
Where
1 siteUnited States
Study dates
16 Jun 2022to Dec 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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)

Who cannot join

  • 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
Show all 13Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Kenzie Brown contact

336-716-9447

BBRP@wakehealth.edu

Charles Tegeler, MD contact

336-716-7651

Charles.Tegeler@wfusm.edu

United States1 site, 1 recruiting

  • Wake Forest University Health Sciences

    Winston-Salem, North Carolina, 27157

    Kenzie Brown, 336-716-9447, BBRP@wakehealth.edu

    Recruiting

Other trials in United States

About this study

Official title: Cereset Research for Caregivers: A Randomized, Controlled Trial

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.

Read the detailed description

Phase I: Intervention only pre-piloting: up to 5 adults; mirroring Phase II characteristics described below

Phase II: 20 caregivers experiencing symptoms of stress, anxiety or insomnia. Primary aims are to:

  1. Evaluate the effect of CR to improve autonomic cardiovascular regulation measured as heart rate variability (HRV) and baroreflex sensitivity (BRS). Impact will be assessed based on changes in standard measures of HRV and BRS such as SDNN, rMSSD, HF Alpha, and Sequence ALL. This will also provide blood pressure values evaluated by an automated oscillometric blood pressure device.
  2. Assess the effect of CR on self-reported symptom inventories of stress, anxiety, insomnia, and caregiver burden and distress.
  3. Insomnia as assessed by the Insomnia Severity Index (ISI).
  4. Behavioral outcomes such as depression (as assessed by the Center for Epidemiological Studies-Depression Scale, CES-D), anxiety (as evaluated by the GAD-7), traumatic stress (as assessed by the PCL-C), and stress (as assessed by the Perceived Stress Scale, PSS).
  5. Overall quality of life as evaluated using the QOLS measure.
  6. Caregiver burden and distress measured with the Zarit Caregiver Burden scale and the Neuropsychiatric Inventory Questionnaire (NPI-Q).
  7. Brief (4-item) caregiver self-efficacy scale.
Conditions
Caregivers
Being tested
Cereset Research
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
Medical subject headings
Anxiety Disorders, Sleep Initiation and Maintenance Disorders, Primary Dysautonomias, Dementia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Cereset ResearchDevice

    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.

Study groups in NCT05209438
Study groupRoleWhat they receive
Cereset ResearchActive comparatorThis will be the active intervention arm using 4 Cereset (CR) sessions and participants will continue current care.
Receives: Device: Cereset Research
ControlSham comparatorParticipants will have 4 CR sessions of sham control tones and also continue their current care.
Receives: Device: Cereset Research

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Blood Pressure Measurements

    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.

    Measured: Baseline; V3 (4-7 weeks following completion of the intervention)

  2. Change in Heart Rate (HR)

    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.

    Measured: Baseline; V3 (4-7 weeks following completion of the intervention)

  3. Change in Heart Rate Variability (HRV)

    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.

    Measured: Baseline; V3 (4-7 weeks following completion of the intervention)

  4. Change in Baroreflex Sensitivity

    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).

    Measured: Baseline; V3 (4-7 weeks following completion of the intervention)

  5. Blood Pressure Variability

    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).

    Measured: Baseline, V3 (4-7 weeks following completion of the intervention)

Secondary outcomes (8)

  1. Severity of Insomnia (ISI)

    The ISI is a 7 question, self-reported measure to evaluate symptoms of insomnia, with responses from 0-4 for each question, yielding scores ranging from 0-28. Lower scores represent better outcomes.

    Measured: Baseline, V2 (0-14 days after intervention completion, and V3 (4-7 weeks following completion of the intervention)

  2. Center for Epidemiologic Studies Depression Scale (CES-D)

    The Center for Epidemiologic Studies Depression Scale (CES-D) is a depression scale, which will help to assess this co-morbidity. CES-D is a 20-item survey assessing affective depressive symptomatology to screen for risk of depression. Scores range from 0-60, with a score of 16 commonly used as a clinically relevant cut-off. The higher the score, the more suggestive of depressive symptoms.

    Measured: Baseline, V2 (0-14 days after intervention completion, and V3 (4-7 weeks following completion of the intervention)

  3. Generalized Anxiety Disorder-7 (GAD-7) scores

    The Generalized Anxiety Disorder-7 (GAD-7) is a seven-item screening tool for anxiety that is widely used in primary care. GAD-7 is a brief, reliable and valid measure of assessing generalized anxiety disorder. A score of 10 or greater on the GAD-7 represents a reasonable cut point for identifying cases. Cut points of 5, 10, and 15 might be interpreted as representing mild, moderate, and severe levels of anxiety.

    Measured: Baseline, V2 (0-14 days after intervention completion, and V3 (4-7 weeks following completion of the intervention)

  4. PTSD Checklist for civilians (PCL-C)

    The PTSD Checklist for civilians (PCL-C), measures the American Psychiatric Association's Diagnostic and statistical manual of mental disorders (DSM-IV) Criteria B, C, \& D of PTSD symptoms based on traumatic life experience either in civilian life. Seventeen items are rated on a Likert scale with a composite score range of 17 to 85. A score of 44 or higher correlates with probability of civilian-related PTSD. Higher scores suggest more traumatic stress.

    Measured: Baseline, V2 (0-14 days after intervention completion, and V3 (4-7 weeks following completion of the intervention)

  5. Perceived Stress Scale (PSS)

    The Perceived Stress Scale (PSS) is a ten-item psychological instrument for measuring the perception of stress. It is a measure of the degree to which situations in one's life are appraised as stressful. Items were designed to tap how unpredictable, uncontrollable, and overloaded respondents find their lives. The scale, with answers rated from 0-4, also includes a number of direct queries about current levels of experienced stress. Total scores range from 0-40. A lower score denotes a lower level of perceived stress.

    Measured: Baseline, V2 (0-14 days after intervention completion, and V3 (4-7 weeks following completion of the intervention)

  6. Quality of Life Scale (QOLS)

    The QOLS is a 16-item scale that was modified from a 15-item scale used in chronic disease patients. Topics include different components of daily life such as relationships, community engagement, personal fulfillment, and recreation. Each item is scaled from 1 to 7 and a sum score is calculated to represent higher levels of satisfaction in life (range is 16-112).

    Measured: Baseline, V2 (0-14 days after intervention completion, and V3 (4-7 weeks following completion of the intervention)

  7. Caregiver Burden (Zarit)

    The Zarit caregiver burden scale scoring system uses a five point scale. Responses can range from zero (which means never) to four (which means nearly always). A screening tool of this type can help identify challenges in a way that is less personal and threatening to the caregiver and the care recipient.

    Measured: Baseline, V2 (0-14 days after intervention completion, and V3 (4-7 weeks following completion of the intervention)

  8. Caregiver Distress (NPI-Q)

    Caregiver distress will be assessed using the Neuropsychiatric Inventory Questionnaire (NPI-Q) and an adaptation of the 22-item Impact of Events Scale-Revised (IES-R) for caregiving. Higher total scores (each question being 0-4 points) equal higher amounts of distress. The rationale for assessing only symptom severity on the NPI-Q is the finding that symptom severity is more strongly correlated with caregiver distress (i.e., more clinically significant) than how often the symptom occurs. The total NPI-Q severity score represents the sum of individual symptom scores and ranges from 0 to 36.

    Measured: Baseline, V2 (0-14 days after intervention completion, and V3 (4-7 weeks following completion of the intervention)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Jan 2022
  2. Study start16 Jun 2022
  3. Primary completionJul 2027 (estimated)
  4. Study completionDec 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Single group
Model description
Prior to the start of the randomized Phase II for the trial, a limited intervention-only pilot will be carried out with up to 5 participants (Phase I). The purpose of this is to confirm feasibility of cohort and identify challenges, intervention, and outcome assessment procedures to ensure they are optimized by the start of the randomized phase, and allow additional time to work towards any obstacles that arise with the placebo. Phase II will be a single-blind, randomized, pilot clinical trial that aims to enroll 20 participants who will be randomized to receive 4 sessions of CR intervention linked to brainwaves (INT) (n=10) or 4 sessions of sham control tones not linked to brainwaves (CON) (n=10). In this study, the tones not linked to brainwaves will be used as the control.
Masking
Single blind
Who is masked
Participant
Enrolment
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05209438
Sponsor's protocol ID
IRB00078620
Status last verified
May 2026
First submitted
12 Jan 2022
Last updated
1 Jun 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Publications

  • Hale TS, Smalley SL, Walshaw PD, Hanada G, Macion J, McCracken JT, McGough JJ, Loo SK. Atypical EEG beta asymmetry in adults with ADHD. Neuropsychologia. 2010 Oct;48(12):3532-9. doi: 10.1016/j.neuropsychologia.2010.08.002. Epub 2010 Aug 10.

    PubMed 20705076

  • Thibodeau R, Jorgensen RS, Kim S. Depression, anxiety, and resting frontal EEG asymmetry: a meta-analytic review. J Abnorm Psychol. 2006 Nov;115(4):715-29. doi: 10.1037/0021-843X.115.4.715.

    PubMed 17100529

  • Spironelli C, Penolazzi B, Angrilli A. Dysfunctional hemispheric asymmetry of theta and beta EEG activity during linguistic tasks in developmental dyslexia. Biol Psychol. 2008 Feb;77(2):123-31. doi: 10.1016/j.biopsycho.2007.09.009. Epub 2007 Oct 2.

    PubMed 17997211

  • Moscovitch DA, Santesso DL, Miskovic V, McCabe RE, Antony MM, Schmidt LA. Frontal EEG asymmetry and symptom response to cognitive behavioral therapy in patients with social anxiety disorder. Biol Psychol. 2011 Jul;87(3):379-85. doi: 10.1016/j.biopsycho.2011.04.009. Epub 2011 May 13.

    PubMed 21571033

  • Kemp AH, Griffiths K, Felmingham KL, Shankman SA, Drinkenburg W, Arns M, Clark CR, Bryant RA. Disorder specificity despite comorbidity: resting EEG alpha asymmetry in major depressive disorder and post-traumatic stress disorder. Biol Psychol. 2010 Oct;85(2):350-4. doi: 10.1016/j.biopsycho.2010.08.001. Epub 2010 Aug 11.

    PubMed 20708650

  • Metzger LJ, Paige SR, Carson MA, Lasko NB, Paulus LA, Pitman RK, Orr SP. PTSD arousal and depression symptoms associated with increased right-sided parietal EEG asymmetry. J Abnorm Psychol. 2004 May;113(2):324-9. doi: 10.1037/0021-843X.113.2.324.

    PubMed 15122952

  • Cohen H, Benjamin J, Geva AB, Matar MA, Kaplan Z, Kotler M. Autonomic dysregulation in panic disorder and in post-traumatic stress disorder: application of power spectrum analysis of heart rate variability at rest and in response to recollection of trauma or panic attacks. Psychiatry Res. 2000 Sep 25;96(1):1-13. doi: 10.1016/s0165-1781(00)00195-5.

    PubMed 10980322

  • Spiegelhalder K, Fuchs L, Ladwig J, Kyle SD, Nissen C, Voderholzer U, Feige B, Riemann D. Heart rate and heart rate variability in subjectively reported insomnia. J Sleep Res. 2011 Mar;20(1 Pt 2):137-45. doi: 10.1111/j.1365-2869.2010.00863.x.

    PubMed 20626615

  • Beauchaine TP, Thayer JF. Heart rate variability as a transdiagnostic biomarker of psychopathology. Int J Psychophysiol. 2015 Nov;98(2 Pt 2):338-350. doi: 10.1016/j.ijpsycho.2015.08.004. Epub 2015 Aug 11.

    PubMed 26272488

  • Minassian A, Geyer MA, Baker DG, Nievergelt CM, O'Connor DT, Risbrough VB; Marine Resiliency Study Team. Heart rate variability characteristics in a large group of active-duty marines and relationship to posttraumatic stress. Psychosom Med. 2014 May;76(4):292-301. doi: 10.1097/PSY.0000000000000056.

    PubMed 24804881

  • Marsac J. [Heart rate variability: a cardiometabolic risk marker with public health implications]. Bull Acad Natl Med. 2013 Jan;197(1):175-86. French.

    PubMed 24672989

  • Thayer JF, Hansen AL, Saus-Rose E, Johnsen BH. Heart rate variability, prefrontal neural function, and cognitive performance: the neurovisceral integration perspective on self-regulation, adaptation, and health. Ann Behav Med. 2009 Apr;37(2):141-53. doi: 10.1007/s12160-009-9101-z. Epub 2009 May 8.

    PubMed 19424767

  • Gerdes L, Gerdes P, Lee SW, H Tegeler C. HIRREM: a noninvasive, allostatic methodology for relaxation and auto-calibration of neural oscillations. Brain Behav. 2013 Mar;3(2):193-205. doi: 10.1002/brb3.116. Epub 2013 Jan 14.

    PubMed 23532171

  • Tegeler CH, Kumar SR, Conklin D, Lee SW, Gerdes L, Turner DP, Tegeler CL, C Fidali B, Houle TT. Open label, randomized, crossover pilot trial of high-resolution, relational, resonance-based, electroencephalic mirroring to relieve insomnia. Brain Behav. 2012 Nov;2(6):814-24. doi: 10.1002/brb3.101. Epub 2012 Oct 28.

    PubMed 23170244

  • Tegeler CL, Gerdes L, Shaltout HA, Cook JF, Simpson SL, Lee SW, Tegeler CH. Successful use of closed-loop allostatic neurotechnology for post-traumatic stress symptoms in military personnel: self-reported and autonomic improvements. Mil Med Res. 2017 Dec 22;4(1):38. doi: 10.1186/s40779-017-0147-0.

    PubMed 29502530

Questions about this trial

What is this clinical trial studying?

A study testing Cereset Research in people with Caregivers, run by Wake Forest University Health Sciences at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 1 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Kenzie Brown (336-716-9447, BBRP@wakehealth.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Blood Pressure Measurements (time frame: Baseline; V3 (4-7 weeks following completion of the intervention)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05209438, which also lists 27 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2026; AzTrials last refreshed its copy on 27 Oct 2026.

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