Abstract Details

Title A Pilot, Placebo-controlled Trial of Closed-loop Acoustic Stimulation Neurotechnology for Insomnia

Topic Sleep

Presentation(s) Sleep Posters (7:00 AM-5:00 PM)

Poster/Presentation
Number 006

Background In prior studies, High-resolution, relational, resonance-based, electroencephalic mirroring (HIRREM®) reduced symptoms of insomnia, and improved heart rate variability (HRV). CR-SOP uses HIRREM core technology, echoing tones linked to brainwaves, but includes updated components, standardized protocols, software management of designs, and shorter sessions to reduce operator dependence and improve scalability. This placebo-controlled crossover pilot trial explores use of CR-SOP for insomnia.

Objective

Evaluate use of Cereset Research-Standard Operating Procedures® (CR-SOP), a noninvasive, closed-loop, acoustic neuromodulation technology, for insomnia.

Design/Methods 22 adults (16 females) with insomnia (ISI, ≥8 points for ≥1 month) enrolled in this controlled pilot trial. Subjects received ten, 60-minute standardized sessions of tones linked to brainwaves (CR-SOP), versus random tones (RT), plus continued current care. Data was collected at baseline (V1), 0-14 days (V2), and 6-8 weeks (V3) after intervention. Primary outcome was 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 could crossover after V3 to receive CR-SOP with V4 (0-14 days), V5 (6-8 weeks) after intervention. We report changes in ISI and HRV.

Results For n=22 (Intent-to-treat, 2 dropouts), change in ISI from V1 to V3 was -7.3 for CR-SOP, and -4.7 for RT (between groups p=0.2). SDNN increased 32.2% (SE 12.8) for CR-SOP, 5.6% (14.7) for RT (p=0.07), while rMSSD increased 88.8% (36.7) for CR-SOP, 33.7% (38.7) for RT (p=0.03), with no serious adverse events reported. 6 subjects crossed-over to receive CR-SOP. From V3 to V5, within group, ISI had an additional -4.3 (p=0.01), SDNN increased 31.3% (p= 0.04), and rMSSD 45.7% (p=0.03).

Conclusions This pilot trial demonstrates clinically meaningful reduction in ISI, and increased HRV with CR-SOP, similar to HIRREM controlled trials, and additional benefit with crossover to CR-SOP. Similar benefits, with improved scalability, suggest potential as an alternative, non-drug intervention for insomnia.

Authors/Disclosures
Charles H. Tegeler, MD (Wake Forest School of Medicine) PRESENTER	Dr. Tegeler has nothing to disclose.
Catherine Tegeler (Wake Forest Sch of Med, Neurology)	Ms. 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
	No disclosure on file
	No disclosure on file
Hossam A. Shaltout, PhD (Wake Forest School of Medicine)	Dr. Shaltout has nothing to disclose.