NCT05209438

Cereset Research for Caregivers

Cereset Research for Caregivers: A Randomized, Controlled Trial

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Wake Forest University Health Sciences · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

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. 1. Insomnia as assessed by the Insomnia Severity Index (ISI). 2. 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). 3. Overall quality of life as evaluated using the QOLS measure. 4. Caregiver burden and distress measured with the Zarit Caregiver Burden scale and the Neuropsychiatric Inventory Questionnaire (NPI-Q). 5. Brief (4-item) caregiver self-efficacy scale.

Conditions

• Caregivers

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2022-06-16
• Primary completion: 2026-07-01
• Completion: 2026-07-01
• First posted: 2022-01-26
• Last updated: 2025-07-15

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study