Cereset Research for Caregivers

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

Interventions

DEVICE

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.

Sponsors & Collaborators

• Memory Counseling Program general fund

  collaborator UNKNOWN

• Heidi Munger-Clary, MD

  collaborator UNKNOWN

• Hossam Shaltout, PhD

  collaborator UNKNOWN

• Sean Simpson, PhD

  collaborator UNKNOWN

• Christina Hugenschmidt, PhD

  collaborator UNKNOWN

• Mia Yang, MD

  collaborator UNKNOWN

• Wake Forest University Health Sciences

  lead OTHER

Principal Investigators

• Charles Tegeler, MD · Wake Forest University Health Sciences

Study Design

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

SINGLE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2022-06-16

Primary Completion

2026-07-31

Completion

2026-07-31

FDA Device

Yes

Countries

• United States

Study Locations