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Randomized Controlled Trial of Acoustic Neuromodulation to Enhance Well-Being in Healthcare Workers
Catherine L Tegeler1, Heidi Munger Clary1, Hossam A Shaltout2
1Department of Neurology, Wake Forest University School of Medicine (WFUSM), Winston-Salem, NC, USA.
Background:
Increased stress in healthcare workers (HCW) is a global crisis and few brief, scalable interventions exist to support HCW with stress, anxiety, and insomnia. Individual interventions impacting these multiple symptoms are needed.
Objective:
To determine whether a noninvasive brainwave echoing acoustic neuromodulation intervention reduces perceived stress among HCW compared to waitlist control.
Methods:
This was a parallel randomized controlled trial of acoustic neuromodulation vs waitlist control conducted at a large academic health system. Adult HCW with Perceived Stress Scale (PSS) ≥14 were included. Exclusions were factors that would compromise intervention delivery or current engagement with similar interventions. The intervention was a limited dose paradigm of Cereset Research™ Standard Operating Procedures, a noninvasive, closed-loop, brainwave echoing acoustic neuromodulation neurotechnology, composed of four, 36-minute acoustic neuromodulation sessions over 2 weeks. The primary outcome was change in PSS at 6-8 weeks. Secondary outcomes were anxiety (Generalized Anxiety Disorder-7) and insomnia (Insomnia Severity Index). Exploratory outcomes included validated measures of depression, fatigue, and subjective cognition. Group-level changes in outcomes were evaluated using linear mixed models.
Results:
Of 144 participants (72 per group), 134 completed primary outcome assessment (67 per group). Participants had mean age 44.7 years [SD 11.6] and were 86.1% female (N = 124). Intention-to-treat analyses demonstrated mean PSS score reduction of 7.8 (SD 5.9) in the intervention group vs 1.2 (SD 4.1) among controls (difference between groups 6.6 points, 95% CI 4.9-8.2, P < 0.0001). Secondary and exploratory measures also demonstrated significant group-level improvements in intervention vs control, and there were no serious adverse events.
Conclusions:
In HCW with elevated stress, acoustic neuromodulation resulted in clinically meaningful improvements in perceived stress, anxiety, and insomnia. The intervention is safe, scalable, and may merit adoption by health systems to complement organization-level approaches for enhancing HCW well-being. Trial Registration: ClinicalTrials.gov, NCT04682197.
