Study of Cereset Research Device to Improve Stress, Sleep, and Caregiver Burden in Adults Caring for People with Dementia

What this Trial Is About

Caregivers often face prolonged stress that can lead to health problems, including a higher risk of cardiovascular disease linked to problems with autonomic nervous system regulation. This study evaluates whether a neuromodulation device called Cereset Research CR can improve heart rate variability HRV, a measure of autonomic cardiovascular function, in caregivers of people living with dementia who experience stress, anxiety, or insomnia. The study also looks at how CR affects self-reported stress, sleep quality, caregiver burden, and related emotional symptoms. Participants will be randomly assigned to receive either four sessions of the CR active intervention or four sessions of sham control tones, while continuing their usual care. The CR system uses sensors placed on the scalp to provide real-time audible feedback of brainwaves, aiming to improve autonomic regulation. The intervention period lasts four weeks, with sessions up to three times per week, each lasting up to 60 minutes. During the study, participants heart rate, blood pressure, heart rate variability, and baroreflex sensitivity will be measured before and after the intervention period. They will also complete questionnaires assessing insomnia severity, depression, anxiety, traumatic stress, perceived stress, quality of life, caregiver burden, distress, and caregiver self-efficacy. Follow-up assessments occur shortly after intervention completion and several weeks later to monitor changes. The entire study participation spans from baseline through follow-up visits four to seven weeks after the intervention ends.

Cereset Research for Caregivers