0523 A Pilot, Placebo-controlled Trial of Closed-Loop, Artificial Intelligence Driven, Acoustic Neuromodulation for Insomnia

Abstract

Abstract Introduction In prior studies, High-resolution, relational, resonance-based, electroencephalic mirroring (HIRREM®) reduced symptoms of insomnia, and improved heart rate variability (HRV), but is operator dependent, and difficult to scale. Cereset Research™ (CR), is a noninvasive, closed-loop, artificial intelligence (AI) driven, acoustic neuromodulation technology. CR uses the same core technology, echoing tones linked to brainwaves, but includes updated components, standardized AI driven protocols, software management of designs, and shorter sessions to improve scalability. This controlled trial explores use of CR for insomnia. Methods Adults with insomnia (Insomnia Severity Index, ISI, of ≥8 points for ≥1 month) receive ten 60 minute sessions of tones linked to brainwaves (CR), versus random tones (RT). Data is collected at baseline (V1), 0-14 days (V2), and 6-8 weeks (V3) after intervention. Primary outcome is change in ISI at V3. Secondary outcomes include HRV (SDNN and rMSSD) based on 10-minute BP and HR recordings using a BIOPAC device. RT subjects can cross-over to CR after V3. Formal analysis of insomnia outcome awaits the target of n = 20 to complete intervention, but we report preliminary changes in ISI, and secondary outcomes, SDNN and rMSSD. Results 21 subjects have enrolled (15 women), with one dropout after first session and one after 6th session due to job changes. For n = 17, change in median ISI score from V1 to V3 is -7 for CR, and -4 for RT. Mean SDNN increased 32.2% (SE 12.8) for CR, and 5.6% (14.7) for RT, while rMSSD increased 88.8% (36.7) for CR, and 33.7% (38.7) for RT, with no serious adverse events reported. Conclusion Preliminary results suggest similar, clinically meaningful reductions in ISI score, and increased HRV with CR, as seen with HIRREM, suggesting promise as a scalable, non-drug intervention for insomnia with accompanying impact on autonomic function. Final results will be presented. Support Research grant from, The Susanne Marcus Collins Foundation, Inc.