Cereset Research for Caregivers: A Randomized, Controlled Trial
Wake Forest University Health Sciences
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.
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\)…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- Yes
Inclusion Criteria: * 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 Se…
Interventions
- DeviceCereset 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.
Location
- Wake Forest University Health SciencesWinston-Salem, North Carolina