Study of Cereset Research to Improve Autonomic Function and Reduce Stress, Anxiety, or Insomnia Symptoms in People Aged 11 and Older

What this Trial Is About

Researchers are evaluating Cereset Research CR, a device-based intervention, to improve autonomic cardiovascular regulation in people aged 11 and older who experience symptoms of stress, anxiety, or insomnia. This open-label exploratory study aims to assess how CR affects heart rate variability, baroreflex sensitivity, and blood pressure variability. Secondary and tertiary objectives include examining changes in self-reported symptoms of insomnia, depression, anxiety, stress, and other related conditions, as well as exploring effects in specific subgroups with co-existing medical issues like PTSD, chronic pain, or prior stroke. Participants will receive between 4 and 12 sessions of CR, which uses audible tones echoing brainwave activity to provide real-time feedback. The intervention involves wearing sensors on the scalp while sitting comfortably with eyes closed. The upgraded CR system includes faster processing and fewer interruptions during sessions. Participants will continue their usual care throughout the study. Data collection will occur before and after the intervention, including physiological measures and symptom questionnaires. During the study, participants will attend an enrollment visit for baseline assessments, followed by the intervention period starting within 14 days. Follow-up assessments will take place 4 to 6 weeks after the final session to measure changes in autonomic function and symptoms. Researchers will also collect additional data on quality of life and specific condition-related outcomes. The study will monitor safety and gather information on medication effects, barriers to treatment, and participant experiences. Total participation duration varies based on the number of sessions received and follow-up timing.

Cereset Research Exploratory Study