Cereset Research Improves Autonomic Function in Stressed Healthcare Workers: A Randomized Clinical Trial
Hossam Shaltout1, Catherine Tegeler2, Gregory Russell3, Kenzie Brown2, Dawn Kellar2, Suzanne Danhauer4, Heidi Munger Clary2, Charles Tegeler2
1Hypertension & Vascular Research Center, 2Neurology, 3Public Health Sciences - Biostatistics and Data Science, 4Public Health Sciences - Social Sciences, Wake Forest School of Medicine
Objective:
To evaluate Cereset Research™ (CR), effect on autonomic regulation in healthcare workers (HCW).
Background:
CR is a closed-loop, acoustic stimulation neurotechnology which improved autonomic regulation in other populations. This trial evaluates CR effect on autonomic regulation in stressed HCW.
Design/Methods:
Adult HCW with stress (Perceived Stress Scale, PSS, of ≥14) enrolled in this waitlist controlled randomized trial. Following consent and baseline measure collection, participants were randomized to early intervention (EI), with 4, 36-minute sessions of CR (tones linked to brainwaves) or a waitlist control condition (WC). Control participants could opt to receive the CR intervention following V3 assessment. Outcomes were collected at 10-24 days (V2; immediate post-intervention for EI group). Primary outcome assessment occurred 4-7 weeks (V3) later. The study was powered to detect a moderate clinically significant between-group difference in change in the PSS score at V3 (primary outcome). Exploratory outcomes included change in heart rate variability (HRV) assessed as standard deviation of beat-to-beat interval (SDNN), root mean square of successive differences (rMSSD), and the ratio of low frequency to high frequency power (LF/HF). Higher SDNN and rMSSD indicates enhanced parasympathetic tone and higher LF/HF indicates higher sympathetic tone. Repeated measures ANOVA analyzed the longitudinal changes between groups.
Results:
Of 144 HCW enrolled, 130 completed HRV data collection for all three visits (84.6% female, mean age 44.0 [SD 10.96]. The adjusted between group differences at V3 in SDNN (milliseconds) were EI 4.8 (SE 1.6), WC 0.3 (1.6) (p=0.049); rMSSD (milliseconds) EI 9.5 (SE 1.5), WC -0.4 (1.5) (p<0.0001); LF/HF ratio: EI -0.48 (SE 0.2), WC 0.19 (0.2) (p=0.018).
Conclusions:
This randomized, waitlist-controlled trial of noninvasive acoustic neuromodulation showed a significant increase in parasympathetic mediated heart rate variability and reduction in sympathetic tone to the heart among stressed HCW. This intervention may be promising for implementation in health systems to improve HCW autonomic regulation.