Abstract Details

Title A Pilot, Placebo-controlled Clinical Trial of Cereset Research for Insomnia

Topic Sleep

Presentation(s) P2 - Poster Session 2 (8:00 AM-9:00 AM)

Poster/Presentation
Number 5-007

Objective Evaluate the use of Cereset Research® (CR), a noninvasive, closed-loop, artificial intelligence (AI) driven, acoustic neuromodulation technology for insomnia.

Background In prior studies, High-resolution, relational, resonance-based, electroencephalic mirroring (HIRREM®) reduced symptoms of insomnia, and improved heart rate variability (HRV). HIRREM is operator dependent, with difficulty scaling. CR uses HIRREM 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 placebo-controlled trial explores use of CR for insomnia.

Design/Methods 18 adults (13 females) with insomnia (Insomnia Severity Index, ISI, of ≥8 points for ≥1 month) are enrolled in this randomized, controlled trial. Subjects receive ten 60 minute sessions of tones linked to brainwaves (CR), versus random tones (RT), plus continued current care. Data is collected at baseline (V1), 0-14 days (V2), and 6-8 weeks (V3) after intervention. Primary outcome is change in ISI score at V3. Secondary outcome includes HRV (SDNN and rMSSD) based on 10-minute BP and HR recordings using a BIOPAC device. RT subjects can cross-over to receive CR after V3. Formal statistical analysis awaits completion of the target of n=20, but we report initial changes in ISI, SDNN and rMSSD.

Results 18 subjects enrolled, with 1 dropout after first session due to job change. 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.

Conclusions This suggests similar, clinically meaningful reductions in ISI score, and increased HRV with CR, as seen previously with HIRREM, suggesting promise as a scalable, non-drug intervention for insomnia. Final results will be presented.

Authors/Disclosures
Catherine Tegeler (Wake Forest Sch of Med, Neurology) PRESENTER	Ms. Tegeler has nothing to disclose.
Charles H. Tegeler, MD (Wake Forest School of Medicine)	Dr. Tegeler has nothing to disclose.
Lindsay J. Howard (Wake Forest Baptist Health)	Ms. Howard has nothing to disclose.
Kenzie Brown	No disclosure on file
Dawn Kellar	No disclosure on file
	No disclosure on file
Hossam A. Shaltout, PhD (Wake Forest School of Medicine)	Dr. Shaltout has nothing to disclose.

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Abstract Details