Cereset Research for Caregivers

NCT05209438 | Recruiting FDA Device

• 1 other identifier: IRB00078620
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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

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

Outcome Measures

Primary Outcomes (5)

• 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.

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

• 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.

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

• 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.

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

• 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).

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

• 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).

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

Secondary Outcomes (8)

• Severity of Insomnia (ISI)

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

• Center for Epidemiologic Studies Depression Scale (CES-D)

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

• Generalized Anxiety Disorder-7 (GAD-7) scores

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

• PTSD Checklist for civilians (PCL-C)

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

• Perceived Stress Scale (PSS)

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

Other Outcomes (2)

• Changes in Chronic Pain (MPQ)

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

• Changes in Chronic Pain (PROMIS)

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

Study Arms (2)

Cereset Research

ACTIVE COMPARATOR

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

Device: Cereset Research

Control

SHAM COMPARATOR

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

Device: Cereset Research

Interventions

Cereset Research DEVICE

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.

Cereset Research; Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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
• participants taking Medications that may affect the assessment of heart rate variability (beta blockers.

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead
• Memory Counseling Program general fund: collaborator
• Heidi Munger-Clary, MD: collaborator
• Hossam Shaltout, PhD: collaborator
• Sean Simpson, PhD: collaborator
• Christina Hugenschmidt, PhD: collaborator
• Mia Yang, MD: collaborator

Study Sites (1)

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157, United States

RECRUITING

Related Publications (27)

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MeSH Terms

Conditions

Anxiety Disorders; Sleep Initiation and Maintenance Disorders; Primary Dysautonomias; Dementia

Condition Hierarchy (Ancestors)

Mental Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Autonomic Nervous System Diseases; Brain Diseases; Central Nervous System Diseases; Neurocognitive Disorders

Study Officials

• Charles Tegeler, MD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kenzie Brown

CONTACT

336-716-9447; BBRP@wakehealth.edu

Charles Tegeler, MD

CONTACT

336-716-7651; ctegeler@wakehealth.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Phase 1 - Participants will receive INT, there is no blinding. Phase 2 - Participants will not be told which group they are assigned to until the end of the study.
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: January 12, 2022
• First Posted: January 26, 2022
• Study Start: June 16, 2022
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: July 15, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)