NCT05994261

Cereset Research Long-Term Healthcare Worker Study

Evaluating Long-Term Feasibility of Cereset Research for Stressed Healthcare Workers

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 94 (actual)
• Sponsor: Wake Forest University Health Sciences · Academic / Other
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Accepted

Summary

Randomized, controlled study of long-term maintenance Cereset Research after an initial 4-session intervention bolus versus usual care control following an initial 4-session intervention bolus.

Detailed description

This randomized, controlled study will evaluate the effects of long-term Cereset Research maintenance intervention in healthcare workers with symptoms of stress in the post era of COVID-19. Healthcare workers of all types have been impacted personally, professionally, and financially by the pandemic and its aftermath, resulting in higher levels of stress and anxiety. Additional, brief, noninvasive, non-drug strategies are needed to help mitigate the effects of the acute trauma associated with the pandemic. The primary outcome will be change in Perceived Stress Scale (PSS) a measurement of how different situations affect feelings and perceived stress in the Intervention group compared to the Control Group. Data will also be collected on a variety of additional relevant symptoms including insomnia, anxiety and autonomic cardiovascular regulation, for which benefits have been shown in prior studies using High-resolution, relational, resonance-based, electroencephalic mirroring (HIRREM). Data collected will assess the long-term effects of a low dose Cereset Research (CR) approach (only 4 sessions) and the importance of long-term maintenance intervention versus control. The Intervention Group will then receive 1 session every 6 weeks beginning 6 weeks after the 4 session bolus is completed. The Control Group continues current care with no additional CR sessions. A successful outcome of reduced stress at 1 year in the Intervention Group vs. Control Group would suggest benefit for long-term maintenance intervention sessions. The effect of this approach on autonomic function and other self-reported symptoms will also be explored. This information will be useful for determining intervention schedules for direct clinical implementation of the intervention. The proposed study might also help to identify characteristics of individuals who may experience differential effects/benefits from application of CR and determine if intermittent "tune-up" sessions may prolong symptom improvement.

Conditions

• Stress
• Anxiety
• Autonomic Dysregulation
• Acoustic Stimulation
• Hyperarousal
• Health Personnel

Interventions

Type	Name	Description
DEVICE	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: 2023-11-06
• Primary completion: 2025-07-01
• Completion: 2025-07-01
• First posted: 2023-08-16
• Last updated: 2025-09-05

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study